natgillin/translations-raw huggingface dataset:
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.
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.
Hens and pigs
kokoši in prašiči
Ipswich, Suffolk, IP7 6RD United Kingdom
Ipswich, Suffolk, IP7 6RD Združeno kraljestvo prašiči, perutnina (piščanci, purani)
Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
Madžarska Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
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.
tveganje neprimernega zdravljenja odtehta morebitno korist dodatne možnosti zdravljenja v malo verjetnem primeru potrjene občutljivosti.
and Hidalgo et al. (2009) 6, that 90-100% of Brachyspira isolates demonstrate in vitro resistance.
navaja, da odpornost in vitro kaže 90 100 % izolatov Brachyspira.
Germany KLAT-Chemie GmbH Visbeker Str. 12
KLAT-Chemie GmbH Visbeker Str. 12 D-26197 Ahlhorn Nemčija
Tylan powder for oral solution Tylosin
Tylan powder for oral solution
Powder, 1 bottle: 70 g
Powder, 1 bottle: 70 g piščanci, purani, prašiči
Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets)
prašiči, perutnina (pitovni piščanci, pitovni piščanci za razplod, kokoši nesnice, nadomestne jarkice)
Pigs, poultry and cattle
prašiči, perutnina in govedo
Pigs Poultry
prašiči piščanci
Kownaty 74
Zalmweg 24
ZOOPAN Produtos Pecuários S.A.
Portugalska ZOOPAN Produtos Pecuários S.A. Rua da Liberdade, n° 77
PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams
PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams svinje, teleta, piščanci in purani
Tylosin tartarate 60 mg/g
Tylosin tartarate 60 mg/g kokoši in prašiči
08150 Parets del Valles (Barcelona)
C-17, km 17. 08150 Parets del Valles (Barcelona)
Tilosina 20% liquida Neofarma Tylosin tartarate
Tilosina 20% Chemifarma Tylosin tartarate
Delete, where applicable, the indication ‘Swine dysentery caused by Brachyspira hyodysenteriae'.
Če je primerno, izbrišite indikacijo »Prašičja dizenterija, ki jo povzroča Brachyspira hyodysenteriae«.
Delete, where applicable, any specific dosing recommendation related to swine dysentery caused by Brachyspira hyodysenteriae.
Če je primerno, izbrišite morebitno posebno priporočilo za odmerjanje, povezano s prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae.
Pigs and chicken
prašiči in piščanci
Valdlauči, Ķekavas pag.,LV
Valdlauči, Ķekavas pag.,LV-1076 Latvija
Tylosintartrat 100% Kompaktat Tylosin tartarate
Tylosintartrat 100% Tylosin tartarate
Pigs, poultry (broilers, pullets, layers and turkeys), bovine (preruminants calves).
1 g/g prašiči, perutnina (pitovni piščanci, jarkice, nesnice in purani), govedo (teleta, ki še ne prežvekujejo)
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
D-30625 Hannover Germany
Kon-Pharma GmbH Senator-Bauer-Str. 34 D-30625 Hannover Nemčija
Germany bela-pharm GmbH & Co. KG Lohner Str. 19
Nemčija bela-pharm GmbH & Co.
Eli Lilly Regional Operations GmbH
Romunija Eli Lilly Regional Operations GmbH Elanco Animal Health
Pigs, broilers and replacement pullets
prašiči, pitovni piščanci in nadomestne jarkice
1g Tylosinum (odpovídající 1.1 g Tylosini tartaras)/1,1 g
1g Tylosinum (odpovídající 1.1 g Tylosini tartaras)/1,1 g teleta, prašiči, piščanci, purani
TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai
TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai prašiči in piščanci
TYLOSIN 75 %, geriamieji milteliai
TYLOSIN 75 %, geriamieji milteliai svinje, piščanci
1 g tylosin (as tylosin tartate) per 1 g of powder
1 g tylosin (as tylosin tartate) per 1 g of powder govedo (teleta) piščanci prašiči purani
Calves, Pigs, ChickensBroilers, Turkeys (not producing eggs for human consumption)
200 g/kg teleta, prašiči, pitovni piščanci, purani (ki ne proizvajajo jajc za prehrano ljudi)
Tylo-Suscit 100% Kompaktat Tylosin tartarate
Tylo-Suscit 100% Kompaktat
Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych
Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych prašiči, pitovni piščanci in jarkice
Pharmasin 20 mg/g Орални гранули за свине
Pharmasin 20 mg/g Орални гранули за свине svinje
Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych
Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych prašiči, pitovni piščanci in jarkice
Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки
Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки prašiči, pitovni piščanci in jarkice
Cattle, pigs, poultry
govedo, prašiči, piščanci, purani
Pharmasin 250 mg/g
PHARMASIN 250 MG/G PREMEZCLA
Calves, Pigs, ChickensBroilers (not producing eggs for human consumption)
Tilosina 20% Pagnini teleta, prašiči, pitovni piščanci (ki ne proizvajajo jajc za prehrano ljudi)
Swine, chicken
prašiči, perutnina
Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки
Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки prašiči, pitovni piščanci in jarkice
Pigs, chicken, turkeys
prašiči, piščanci, purani
Pharmasin 1000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves
Pharmasin 1000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves govedo, prašiči, piščanci, purani
Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae.
Če je primerno, izbrišite morebitno referenco na prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae.
Tilosina 20% Vetoquinol
Tilosina 20% Vetoquinol prašiči, piščanci
PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS
PHARMASIN 20 G/KG PREMELANGE
TRELACON G 50 PREMEZCLA Tylosin
TRELACON G 50 PREMEZCLA Tylosin prašiči, perutnina
TILOSINA 100 GANADEXIL
TILOSINA 100 GANADEXIL Tylosin tartarate
Pharmasin 100 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets
Pharmasin 100 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets prašiči perutnina
Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets
Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets prašiči perutnina
1.1 g of granules contains 1 g of tylosin
1.1 g of granules contains 1 g of tylosin teleta, prašiči, piščanci, purani
Poultry, pig
Tylmasin perutnina, prašiči
Klato lan feed
Klato lan feed prašiči piščanci
Pigs, chicken (broiler), turkeys
prašiči, piščanci (pitovni), purani
Calves, pigs, poultry
teleta, prašiči, piščanci, purani
Calves Pigs Chicken Turkey
teleta prašiči piščanci purani
Pigs, chickens, turkeys and calves
prašiči, piščanci, purani in teleta
Cattle Chickens Pigs
Klato lan prašiči piščanci
, Karlsson et al. (1999)
, Karlsson in sod.
Germany Huvepharma NV Uitbreidingstraat 80
Romunija Huvepharma NV Uitbreidingstraat 80
Lithuania Huvepharma NV Uitbreidingstraat 80
Madžarska Huvepharma NV Uitbreidingstraat 80
Pigs
Ciper
TYLAN 100 mg/g premix
PHARMASIN 100 MG/G PREMEZCLA
Chickens (broilers, pullets, laying hens), turkeys, pigs, calves
PURTYL, geriamieji milteliai piščanci, purani, svinje in teleta
Cattle, chickens, turkeys and pigs
1 g/g govedo, piščanci, purani in prašiči
Oral solution Calves, chickens, pigs
peroralna raztopina teleta, piščanci, prašiči
108.18 g/110 g Powder for oral solution
108.18 g/110 g prašek za peroralno raztopino piščanci, purani in prašiči
Poultry, swine, calves
prašiči, pitovni piščanci, jarkice
This summary was last updated in 12-2012.
Povzetek je bil nazadnje posodobljen 12-2012.
The patches should not be cut into pieces.
Ne sme se jih rezati na manjše koščke.
The European Commission granted a marketing authorisation valid throughout the European Union for Prometax on 4 December 1998.
Evropska komisija je dovoljenje za promet z zdravilom Prometax, veljavno po vsej Evropski uniji, odobrila dne 4. decembra 1998.
The starting dose is 1.5 mg twice a day.
Začetni odmerek je 1,5 mg dvakrat na dan.
EPAR summary for the public rivastigmine
Povzetek EPAR za javnost rivastigmin
The patches can be worn during bathing and hot weather.
Obliže je mogoče nositi tudi med kopanjem in v toplem vremenu.
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).
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).
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.
Vendar pa je po ponovni presoji svojega mnenja zaključil, da lahko skromna učinkovitost zdravila koristi nekaterim bolnikom.
The full EPAR for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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.
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.
Kapsule so proučevali pri 2 126 bolnikih v treh glavnih študijah, transdermalne obliže pa v eni glavni študiji, ki je vključevala 1 195 bolnikov.
The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Obliže je treba prilepiti na čisto, suho, nepoškodovano in neporaščeno kožo na hrbtu, nadlakti ali prsih in zamenjati vsakih 24 ur.
This is a summary of the European public assessment report (EPAR) for Prometax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prometax.
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.
Zdravljenje je treba nadaljevati, dokler je zdravilo učinkovito, vendar se lahko odmerek zmanjša ali zdravljenje prekine, če se pri bolniku pojavijo neželeni učinki.
Other information about Prometax
Druge informacije o zdravilu Prometax
Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
Kapsule ali peroralna raztopina zdravila Prometax se dajejo dvakrat na dan ob jutranjem in večernem obroku.
The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Prometax's benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Prometax ne odtehtajo njegovih tveganj.
This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Rezultat so primerjali s povečanjem za 2,6 točke od 22,5 pri bolnikih, ki so jemali placebo.
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.
CHMP je zaključil, da ima zdravilo Prometax pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
What measures are being taken to ensure the safe use of Prometax?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Prometax?
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.
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.
All of the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment).
Vse študije so trajale šest mesecev, v njih pa so primerjali učinke zdravila Prometax z učinki placeba (zdravila brez zdravilne učinkovine).
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.
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.
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).
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).
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.
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.
Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Prometax by the patient.
Zdravljenje se lahko začne samo, če je na voljo negovalec, ki bo redno dajal zdravilo in spremljal uporabo zdravila Prometax pri bolniku.
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.
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.
For more information about treatment with Prometax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
Therefore, the Committee decided that Prometax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Prometax večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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.
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.
Prometax capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Kapsule zdravila Prometax so proučevali tudi pri 541 bolnikih z demenco kot posledico Parkinsonove bolezni.
What benefit has Prometax shown during the studies?
Kakšne koristi je zdravilo Prometax izkazalo med študijami?
Prometax must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Zdravila Prometax ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
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.
Z dodatno študijo s 27 bolniki so dokazali, da kapsule in peroralna raztopina zdravila Prometax dosegajo podobne ravni zdravilne učinkovine v krvi.
The Prometax transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Transdermalni obliži Prometax so bili ravno tako učinkovitejši od placeba pri preprečevanju poslabšanja demence.
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.
Ne smejo se prilepiti na vzdraženo ali pordelo kožo, na stegno ali trebuh ali na predele, kjer bi se drgnili ob tesna oblačila.
The global symptom score also improved more in the patients taking Prometax.
Tudi rezultat celostne ocene simptomov je bil boljši pri bolnikih, ki so jemali zdravilo Prometax.
It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6 , 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Na voljo je v obliki kapsul (1,5 mg, 3 mg, 4,5 mg in 6 mg), kot peroralna raztopina (2 mg/ml) in transdermalni obliž, ki v 24 urah skozi kožo sprosti 4,6 mg, 9,5 mg ali 13,3 mg rivastigmina.
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Rivastigmin deluje tako, da zavira encima, ki razgrajujeta acetilholin: acetilholinesterazo in butirilholinesterazo.
The company that makes Prometax must ensure that all doctors who intend to prescribe Prometax transdermal patch receive an information pack containing instructions to be given to patients and caregivers on how to use the patch safely as well as a reminder card for patients and caregivers that contains key information on how to use the patch and allows them to record the application and removal of patches.
Družba, ki proizvaja zdravilo Prometax mora zagotoviti, da vsi zdravniki, ki bodo predpisovali transdermalne obliže zdravila Prometax v odmerku 13,3 mg/24 ur, prejmejo informacijsko gradivo z navodili za varno uporabo obližev, ki jih je treba posredovati bolnikom in negovalcem, ter opozorilno kartico za bolnike in negovalce, ki vsebuje ključne informacije o načinu uporabe obližev in beležko za vodenje evidence o namestitvi in odstranitvi obližev.
The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Kapsule in peroralna raztopina se lahko uporabljajo tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
Prometax was more effective than placebo at controlling symptoms.
Zdravilo Prometax je bilo pri obvladovanju simptomov učinkovitejše od placeba.
Prometax is a medicine containing the active substance rivastigmine.
Prometax je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Vrste neželenih učinkov, opaženih pri zdravilu Prometax, so odvisne od vrste demence, ki se zdravi, in od tega, ali se uporabljajo kapsule, peroralna raztopina ali transdermalni obliži.
By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Zdravilo Prometax z zaviranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi Alzheimerjeve demence in demence zaradi Parkinsonove bolezni ublažijo.
For the transdermal patch application site reactions are the most commonly seen side effects.
Pri uporabi transdermalnega obliža so najpogostejši neželeni učinki reakcije na mestu uporabe obliža.
Prometax has been studied in mild to moderately severe Alzheimer's disease.
Zdravilo Prometax so proučevali pri blagi do zmerno hudi Alzheimerjevi bolezni.
In the three studies of Prometax capsules in patients with Alzheimer's dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
V treh študijah zdravila Prometax pri bolnikih z Alzheimerjevo demenco je bilo pri tistih, ki so jemali od 6- do 9miligramske odmerke zdravila Prometax, opaziti povprečno povečanje kognitivnih simptomov za 0,2 točke od izhodiščne vrednosti 22,9 točke na začetku študije, pri čemer nižji rezultat pomeni boljšo učinkovitost.
What is the risk associated with Prometax?
Kakšna tveganja so povezana z zdravilom Prometax?
The patients with dementia due to Parkinson's disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule zdravila Prometax, je bilo opaziti izboljšanje kognitivnih simptomov za 2,1 točke, v primerjavi s poslabšanjem za 0,7 točke pri tistih, ki so jemali placebo, od izhodiščne vrednosti približno 24 točk.
The active substance in Prometax, rivastigmine, is an antidementia medicine.
Zdravilna učinkovina zdravila Prometax, rivastigmin, je zdravilo za zdravljenje demence.
For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Kar zadeva rezultat celostne ocene simptomov, je pri bolnikih, ki so jemali kapsule zdravila Prometax, prišlo do povečanja simptomov za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
Patients can be switched from the capsules or oral solution to the patches.
Bolniki lahko s kapsul ali peroralne raztopine preidejo na obliže.
Why has Prometax been approved?
Zakaj je bilo zdravilo Prometax odobreno?
For the full list of all side effects reported with Prometax, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prometax, glejte navodilo za uporabo.
See the summary of product characteristics (also part of the EPAR) for detailed information.
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/24 h patch after at least four weeks if the lower dose is well tolerated.
Če se uporabljajo transdermalni obliži, je treba najprej uporabiti obliž, ki v 24 urah sprosti 4,6 mg učinkovine, po najmanj štirih tednih pa je odmerek mogoče povečati na 9,5 mg v 24 urah, če bolnik nižji odmerek dobro prenaša.
The 9.5 mg/24 h patch should be used for as long as the patient benefits from it. After six months of treatment with 9.5 mg/24 hours, the doctor may increase the dose to 13.3 mg/24 hours if the patient's condition has worsened.
Po šestih mesecih zdravljenja z obližem, ki vsebuje odmerek 9,5 mg/24 ur, lahko zdravnik odmerke poviša na 13,3 mg/24 ur, če se bolnikovo stanje poslabša.
In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Pri bolnikih, ki prenašajo navedeni odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler se ne doseže stalni odmerek 3 do 6 mg dvakrat na dan. Za dosego največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar ta ne sme preseči 6 mg dvakrat na dan.