FrancophonIA/ELRC3.0 huggingface dataset:
English: Ceva Salute Animale S.p.A. Viale Colleoni, 15
Slovenian: Viale Colleoni, 15
English: Rua da Liberdade, n° 77 2050-023 Aveiras de Baixo Portugal
Slovenian: 2050-023 Aveiras de Baixo Portugalska
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 4.5 should be added: For information regarding swine dysentery see section 4.5.
Slovenian: Če indikacija(e) za neko zdravilo ne vključuje(jo) prašičje dizenterije, vendar ne izključuje(jo) take uporabe, je treba dodati referenco na poglavje 4.5: Za informacije o prašičji dizenteriji glejte poglavje 4.5.
English: Elanco Animal Health Kölblgasse 8-10
Slovenian: Elanco Animal Health Grootslag 1-5
English: Pigs and chickens (not producing eggs for human consumption)
Slovenian: Tylmasin prašiči in piščanci (ki ne proizvajajo jajc za prehrano ljudi)
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 12 should be added: For information regarding swine dysentery see section 12.
Slovenian: Če indikacija(e) za neko zdravilo ne vključuje(jo) prašičje dizenterije, vendar ne izključuje(jo) take uporabe, je treba dodati referenco na poglavje 12: Za informacije o prašičji dizenteriji glejte poglavje 12.
English: Pharmasin 500 WSP 500 mg/g ūdenī šķīstošs pulveris iekšķīgai lietošanai cūkām, liellopiem, vistām un tītariem
Slovenian: Pharmasin 500 WSP 500 mg/g ūdenī šķīstošs pulveris iekšķīgai lietošanai cūkām, liellopiem, vistām un tītariem govedo, prašiči, piščanci, purani
English: IRIS Mednarodna trgovina d.o.o.,
Slovenian: Slovenija IRIS Mednarodna trgovina d.o.o., Cesta v Gorice 8
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 12: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Slovenian: Če indikacija(e) za neko zdravilo ne vključuje(jo) prašičje dizenterije, vendar ne izključuje(jo) take uporabe, je treba poglavju 12 dodati naslednji stavek: Pri evropskih sevih Brachyspira hyodysenteriae so ugotovili velik delež odpornosti in vitro, kar kaže, da zdravilo ne bo dovolj učinkovito proti prašičji dizenteriji.
English: TYLOSINA BMP Powder Τylosin (from tylosin tartrate) 200 g/Kg
Slovenian: TYLOSINA BMP Powder Τylosin (from tylosin tartrate) 200 g/Kg Φαρμακούχο πρόμιγμα σε κόκκους για χοίρους και κοτόπουλα κρεωπαραγωγής
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 4.5: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Slovenian: Če indikacija(e) za neko zdravilo ne vključuje(jo) prašičje dizenterije, vendar ne izključuje(jo) take uporabe, je treba poglavju 4.5 dodati naslednji stavek: Pri evropskih sevih Brachyspira hyodysenteriae so ugotovili velik delež odpornosti in vitro, kar kaže, da zdravilo ne bo dovolj učinkovito proti prašičji dizenteriji.
English: Tylan Soluble bottle: 100 g bag: 1000g
Slovenian: Tylan Soluble bottle: 100 g bag: 1000g piščanci, purani, prašiči
English: Lithuania Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
Slovenian: Romunija Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
English: Therefore, on 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Slovenian: Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo peroralno v krmo ali vodo za pitje prašičev.
English: Hens and pigs
Slovenian: kokoši in prašiči
English: Ipswich, Suffolk, IP7 6RD United Kingdom
Slovenian: Ipswich, Suffolk, IP7 6RD Združeno kraljestvo prašiči, perutnina (piščanci, purani)
English: Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
Slovenian: Madžarska Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
English: CONCENTRAT V007 TYLAN 100 Tylosin phosphate
Slovenian: CONCENTRAT V007 TYLAN
English: However, effective alternatives are available (e.g. pleuromutilins) and, as there are very few susceptible outbreaks, the risk for inadequate treatment is deemed to outweigh the possible benefit of an additional treatment option in the unlikely event of confirmed susceptibility.
Slovenian: tveganje neprimernega zdravljenja odtehta morebitno korist dodatne možnosti zdravljenja v malo verjetnem primeru potrjene občutljivosti.
English: and Hidalgo et al. (2009) 6, that 90-100% of Brachyspira isolates demonstrate in vitro resistance.
Slovenian: navaja, da odpornost in vitro kaže 90 100 % izolatov Brachyspira.
English: Germany KLAT-Chemie GmbH Visbeker Str. 12
Slovenian: KLAT-Chemie GmbH Visbeker Str. 12 D-26197 Ahlhorn Nemčija
English: Tylan powder for oral solution Tylosin
Slovenian: Tylan powder for oral solution
English: Dopharma Reasearch B.V. Zalmweg 24
Slovenian: Nizozemska Dopharma Reasearch B.V.
English: Powder, 1 bottle: 70 g
Slovenian: Powder, 1 bottle: 70 g piščanci, purani, prašiči
English: Lithuania Dopharma Research B.V. Zalmweg 24, 4941 VX Raamsdonksveer, the Netherlands
Slovenian: Zalmweg 24, 4941 VX Raamsdonksveer, Nizozemska
English: Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets)
Slovenian: prašiči, perutnina (pitovni piščanci, pitovni piščanci za razplod, kokoši nesnice, nadomestne jarkice)
English: Pigs, poultry and cattle
Slovenian: prašiči, perutnina in govedo
English: Pigs Poultry
Slovenian: prašiči piščanci
English: Kownaty 74
Slovenian: Zalmweg 24
English: ZOOPAN Produtos Pecuários S.A.
Slovenian: Portugalska ZOOPAN Produtos Pecuários S.A. Rua da Liberdade, n° 77
English: PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams
Slovenian: PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams svinje, teleta, piščanci in purani
English: Tylosin tartarate 60 mg/g
Slovenian: Tylosin tartarate 60 mg/g kokoši in prašiči
English: Lithuania bela-pharm GmbH & Co. KG Lohner Str. 19
Slovenian: Litva bela-pharm GmbH & Co.
English: 08150 Parets del Valles (Barcelona)
Slovenian: C-17, km 17. 08150 Parets del Valles (Barcelona)
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Markiesstraat 1
Slovenian: Elanco Animal Health Markiesstraat 1
English: Tilosina 20% liquida Neofarma Tylosin tartarate
Slovenian: Tilosina 20% Chemifarma Tylosin tartarate
English: Delete, where applicable, the indication ‘Swine dysentery caused by Brachyspira hyodysenteriae'.
Slovenian: Če je primerno, izbrišite indikacijo »Prašičja dizenterija, ki jo povzroča Brachyspira hyodysenteriae«.
English: Delete, where applicable, any specific dosing recommendation related to swine dysentery caused by Brachyspira hyodysenteriae.
Slovenian: Če je primerno, izbrišite morebitno posebno priporočilo za odmerjanje, povezano s prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae.
English: TYLOSINE BUVABLE NOE
Slovenian: TYLOSINE BUVABLE NOE Tylosin tartarate
English: Pigs and chicken
Slovenian: prašiči in piščanci
English: Valdlauči, Ķekavas pag.,LV
Slovenian: Valdlauči, Ķekavas pag.,LV-1076 Latvija
English: Tylosintartrat 100% Kompaktat Tylosin tartarate
Slovenian: Tylosintartrat 100% Tylosin tartarate
English: Pigs, poultry (broilers, pullets, layers and turkeys), bovine (preruminants calves).
Slovenian: 1 g/g prašiči, perutnina (pitovni piščanci, jarkice, nesnice in purani), govedo (teleta, ki še ne prežvekujejo)
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Slovenian: Dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
English: D-30625 Hannover Germany
Slovenian: Kon-Pharma GmbH Senator-Bauer-Str. 34 D-30625 Hannover Nemčija
English: Germany bela-pharm GmbH & Co. KG Lohner Str. 19
Slovenian: Nemčija bela-pharm GmbH & Co.
English: Eli Lilly Regional Operations GmbH
Slovenian: Romunija Eli Lilly Regional Operations GmbH Elanco Animal Health
English: Pigs, broilers and replacement pullets
Slovenian: prašiči, pitovni piščanci in nadomestne jarkice
English: Germany Dopharma Research B.V. Zalmweg 24
Slovenian: Dopharma Research B.V.
English: 1g Tylosinum (odpovídající 1.1 g Tylosini tartaras)/1,1 g
Slovenian: 1g Tylosinum (odpovídající 1.1 g Tylosini tartaras)/1,1 g teleta, prašiči, piščanci, purani
English: TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai
Slovenian: TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai prašiči in piščanci
English: TYLOSIN 75 %, geriamieji milteliai
Slovenian: TYLOSIN 75 %, geriamieji milteliai svinje, piščanci
English: 1 g tylosin (as tylosin tartate) per 1 g of powder
Slovenian: 1 g tylosin (as tylosin tartate) per 1 g of powder govedo (teleta) piščanci prašiči purani
English: Calves, Pigs, ChickensBroilers, Turkeys (not producing eggs for human consumption)
Slovenian: 200 g/kg teleta, prašiči, pitovni piščanci, purani (ki ne proizvajajo jajc za prehrano ljudi)
English: Tylo-Suscit 100% Kompaktat Tylosin tartarate
Slovenian: Tylo-Suscit 100% Kompaktat
English: Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych
Slovenian: Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych prašiči, pitovni piščanci in jarkice
English: Pharmasin 20 mg/g Орални гранули за свине
Slovenian: Pharmasin 20 mg/g Орални гранули за свине svinje
English: Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych
Slovenian: Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych prašiči, pitovni piščanci in jarkice
English: Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки
Slovenian: Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки prašiči, pitovni piščanci in jarkice
English: Cattle, pigs, poultry
Slovenian: govedo, prašiči, piščanci, purani
English: TYLAN vodorozpustný prášok Tylosin tartarate
Slovenian: TYLAN vodorozpustný prášok
English: Pharmasin 250 mg/g
Slovenian: PHARMASIN 250 MG/G PREMEZCLA
English: Calves, Pigs, ChickensBroilers (not producing eggs for human consumption)
Slovenian: Tilosina 20% Pagnini teleta, prašiči, pitovni piščanci (ki ne proizvajajo jajc za prehrano ljudi)
English: Swine, chicken
Slovenian: prašiči, perutnina
English: Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки
Slovenian: Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки prašiči, pitovni piščanci in jarkice
English: Pigs, chicken, turkeys
Slovenian: prašiči, piščanci, purani
English: Pharmasin 1000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves
Slovenian: Pharmasin 1000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves govedo, prašiči, piščanci, purani
English: Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae.
Slovenian: Če je primerno, izbrišite morebitno referenco na prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae.
English: Tilosina 20% Vetoquinol
Slovenian: Tilosina 20% Vetoquinol prašiči, piščanci
English: PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS
Slovenian: PHARMASIN 20 G/KG PREMELANGE
English: TRELACON G 50 PREMEZCLA Tylosin
Slovenian: TRELACON G 50 PREMEZCLA Tylosin prašiči, perutnina
English: TILOSINA 100 GANADEXIL
Slovenian: TILOSINA 100 GANADEXIL Tylosin tartarate
English: Pharmasin 100 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets
Slovenian: Pharmasin 100 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets prašiči perutnina
English: Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets
Slovenian: Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets prašiči perutnina
English: 40 000 000 IU (50g) Powder for oral solution
Slovenian: 40 000 000 IU (50g)
English: 1.1 g of granules contains 1 g of tylosin
Slovenian: 1.1 g of granules contains 1 g of tylosin teleta, prašiči, piščanci, purani
English: Poultry, pig
Slovenian: Tylmasin perutnina, prašiči
English: Klato lan feed
Slovenian: Klato lan feed prašiči piščanci
English: Pigs, chicken (broiler), turkeys
Slovenian: prašiči, piščanci (pitovni), purani
English: Calves, pigs, poultry
Slovenian: teleta, prašiči, piščanci, purani
English: Calves Pigs Chicken Turkey
Slovenian: teleta prašiči piščanci purani
English: Pigs, chickens, turkeys and calves
Slovenian: prašiči, piščanci, purani in teleta
English: Cattle Chickens Pigs
Slovenian: Klato lan prašiči piščanci
English: Torre Occidente Rua Galileu Galilei, n.º 2 Piso 7 fração A/D, 1500-392 Lisboa Portugal
Slovenian: Rua Galileu Galilei, n.º 2
English: , Karlsson et al. (1999)
Slovenian: , Karlsson in sod.
English: Germany Huvepharma NV Uitbreidingstraat 80
Slovenian: Romunija Huvepharma NV Uitbreidingstraat 80
English: Lithuania Huvepharma NV Uitbreidingstraat 80
Slovenian: Madžarska Huvepharma NV Uitbreidingstraat 80
English: Pigs
Slovenian: Ciper
English: TYLAN 100 mg/g premix
Slovenian: PHARMASIN 100 MG/G PREMEZCLA
English: Chickens (broilers, pullets, laying hens), turkeys, pigs, calves
Slovenian: PURTYL, geriamieji milteliai piščanci, purani, svinje in teleta
English: Denmark Huvepharma NV Uitbreidingstraat 80
Slovenian: Nizozemska Huvepharma NV Uitbreidingstraat 80
English: Cattle, chickens, turkeys and pigs
Slovenian: 1 g/g govedo, piščanci, purani in prašiči
English: Oral solution Calves, chickens, pigs
Slovenian: peroralna raztopina teleta, piščanci, prašiči
English: 108.18 g/110 g Powder for oral solution
Slovenian: 108.18 g/110 g prašek za peroralno raztopino piščanci, purani in prašiči
English: Poultry, swine, calves
Slovenian: prašiči, pitovni piščanci, jarkice
English: This summary was last updated in 12-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 12-2012.
English: The patches should not be cut into pieces.
Slovenian: Ne sme se jih rezati na manjše koščke.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prometax on 4 December 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Prometax, veljavno po vsej Evropski uniji, odobrila dne 4. decembra 1998.
English: The starting dose is 1.5 mg twice a day.
Slovenian: Začetni odmerek je 1,5 mg dvakrat na dan.
English: EPAR summary for the public rivastigmine
Slovenian: Povzetek EPAR za javnost rivastigmin
English: The patches can be worn during bathing and hot weather.
Slovenian: Obliže je mogoče nositi tudi med kopanjem in v toplem vremenu.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Slovenian: Glavno merilo učinkovitosti je bila sprememba simptomov na dveh glavnih področjih: kognitivnem (sposobnost mišljenja, učenja in pomnjenja) in celostnem (kombinacija več področij, vključno s splošno funkcijo, kognitivnimi simptomi, vedenjem in sposobnostjo izvajanja vsakodnevnih dejavnosti).
English: However, following a re-examination of this opinion, the Committee concluded that the medicine's modest effectiveness could also be of benefit to some of these patients.
Slovenian: Vendar pa je po ponovni presoji svojega mnenja zaključil, da lahko skromna učinkovitost zdravila koristi nekaterim bolnikom.
English: The full EPAR for Prometax 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 Prometax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Slovenian: Kapsule so proučevali pri 2 126 bolnikih v treh glavnih študijah, transdermalne obliže pa v eni glavni študiji, ki je vključevala 1 195 bolnikov.
English: The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Slovenian: Obliže je treba prilepiti na čisto, suho, nepoškodovano in neporaščeno kožo na hrbtu, nadlakti ali prsih in zamenjati vsakih 24 ur.
English: This is a summary of the European public assessment report (EPAR) for Prometax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prometax.
English: Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Slovenian: Zdravljenje je treba nadaljevati, dokler je zdravilo učinkovito, vendar se lahko odmerek zmanjša ali zdravljenje prekine, če se pri bolniku pojavijo neželeni učinki.
English: Other information about Prometax
Slovenian: Druge informacije o zdravilu Prometax
English: Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
Slovenian: Kapsule ali peroralna raztopina zdravila Prometax se dajejo dvakrat na dan ob jutranjem in večernem obroku.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Prometax's benefits did not outweigh its risks.
Slovenian: Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Prometax ne odtehtajo njegovih tveganj.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Slovenian: Rezultat so primerjali s povečanjem za 2,6 točke od 22,5 pri bolnikih, ki so jemali placebo.
English: The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Slovenian: CHMP je zaključil, da ima zdravilo Prometax pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
English: What measures are being taken to ensure the safe use of Prometax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Prometax?
English: Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Prometax is being increased.
Slovenian: Na splošno sta med najpogostejšimi neželenimi učinki (opaženimi pri več kot 1 bolniku od 10) navzeja (slabost) in bruhanje, zlasti v obdobju povečevanja odmerka zdravila Prometax.
English: All of the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment).
Slovenian: Vse študije so trajale šest mesecev, v njih pa so primerjali učinke zdravila Prometax z učinki placeba (zdravila brez zdravilne učinkovine).
English: Prometax is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Slovenian: Zdravilo Prometax se uporablja za zdravljenje bolnikov z blago do zmerno hudo Alzheimerjevo demenco, napredujočo okvaro možganov, ki postopoma prizadene spomin, intelektualne zmožnosti in vedenje.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Slovenian: Pri bolnikih z Alzheimerjevo demenco ali demenco zaradi Parkinsonove bolezni v možganih odmirajo določene živčne celice, zaradi česar se znižajo ravni živčnega prenašalca acetilholina (snovi, ki omogoča medsebojno komunikacijo med živčnimi celicami).
English: Prometax must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Prometax patch.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, pri katerih obstaja sum, da so v preteklosti doživeli hudo alergijsko reakcijo, imenovano „alergijski kontaktni dermatitis“, na obliže zdravila Prometax.
English: Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Prometax by the patient.
Slovenian: Zdravljenje se lahko začne samo, če je na voljo negovalec, ki bo redno dajal zdravilo in spremljal uporabo zdravila Prometax pri bolniku.
English: Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Slovenian: Zdravljenje z zdravilom Prometax mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve bolezni ali demence pri bolnikih s Parkinsonovo boleznijo.
English: For more information about treatment with Prometax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Prometax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Therefore, the Committee decided that Prometax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Prometax večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prometax.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prometax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Prometax capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Slovenian: Kapsule zdravila Prometax so proučevali tudi pri 541 bolnikih z demenco kot posledico Parkinsonove bolezni.
English: What benefit has Prometax shown during the studies?
Slovenian: Kakšne koristi je zdravilo Prometax izkazalo med študijami?
English: Prometax must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Slovenian: Zdravila Prometax ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
English: An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Slovenian: Z dodatno študijo s 27 bolniki so dokazali, da kapsule in peroralna raztopina zdravila Prometax dosegajo podobne ravni zdravilne učinkovine v krvi.
English: The Prometax transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Slovenian: Transdermalni obliži Prometax so bili ravno tako učinkovitejši od placeba pri preprečevanju poslabšanja demence.
English: They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Slovenian: Ne smejo se prilepiti na vzdraženo ali pordelo kožo, na stegno ali trebuh ali na predele, kjer bi se drgnili ob tesna oblačila.