natgillin/translations-raw huggingface dataset:
Not known side effects (frequency cannot be estimated from the available data) − swelling of the face and throat (angioedema), trouble breathing (dyspnea)
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Under conditions of clinical use, fidaxomicin has no clinically relevant effect on the exposure of rosuvastatin, a substrate for OATP2B1 and BCRP (see section 4.5).
Pod pogoji za klinično uporabo, fidaksomicin nima klinično pomembnega vpliva na izpostavljenost rosuvastatinu, substratu za
Marketing Authorisation Holder Astellas Pharma Europe B.V. Sylviusweg 62
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Astellas Pharma Europe B.V.
See section 4.
− Navodilo shranite.
18 October 2012
18. oktober 2012
It was expected to be available as tablets (20 mg/10 mg).
Na voljo naj bi bilo v obliki tablet (20 mg/10 mg).
The company did not carry out any new studies in patients with Alzheimer's disease.
Družba ni izvedla nobenih novih študij z bolniki z Alzheimerjevo boleznijo.
In addition, the company pooled and analysed the results from the different studies together.
Družba je prav tako zbrala in skupno analizirala izsledke različnih študij.
What consequences does this refusal have for patients in clinical trials?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih?
Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Živčni prenašalci so kemične snovi v živčnem sistemu, ki omogočajo medsebojno sporazumevanje živčnih celic.
The effectiveness of the combination treatment was assessed by comparing the patients' performance in cognitive tests and in carrying out daily living activities.
Učinkovitost kombiniranega zdravljenja so ocenili s primerjanjem uspešnosti bolnikov na preskusih kognitivnih sposobnosti in pri izvajanju vsakodnevnih opravil.
The effects of Acrescent were first tested in experimental models before being studied in humans.
Učinki zdravila Acrescent so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The company that applied for authorisation is H. Lundbeck A/S, Denmark.
Zahtevo za dovoljenje za promet z zdravilom je vložila danska družba H. Lundbeck A/S.
The causes of Alzheimer's disease are unknown, but the associated memory loss, disorientation and behavioural symptoms are believed to be due to a disturbance of neurotransmitters in the brain.
Vzroki za pojav Alzheimerjeve bolezni niso znani, z njo povezana izguba spomina, izguba orientacije in vedenjski simptomi pa naj bi bili posledica motenj živčnih prenašalcev v možganih.
However, the CHMP considered that the treatment guidelines were not consistent across European countries and the company had not provided enough evidence to support the use of a combination tablet in these patients.
Ne glede na to odbor CHMP meni, da smernice za zdravljenje niso skladne v vseh evropskih državah in da družba ni zagotovila dovolj dokazov, ki bi podpirali uporabo kombiniranih tablet pri teh bolnikih.
On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Acrescent, intended for the treatment of moderate to moderately severe Alzheimer's disease in patients who are already taking memantine and donepezil.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 18. oktobra 2012 sprejel negativno mnenje, s katerim priporoča zavrnitev odobritve dovoljenja za promet z zdravilom Acrescent, ki naj bi se uporabljalo za zdravljenje zmerne do zmerno hude Alzheimerjeve bolezni pri bolnikih, ki že prejemajo memantin in donepezil.
The company also presented information intended to show the use of memantine and donepezil in combination to treat Alzheimer's disease across the European Union, including the available guidelines for treating Alzheimer's disease in different European countries.
Predložila je tudi podatke, ki naj bi prikazali uporabo memantina v kombinaciji z donepezilom za zdravljenje Alzheimerjeve bolezni v Evropski uniji, vključno z razpoložljivimi smernicami za zdravljenje Alzheimerjeve bolezni v različnih evropskih državah.
One main study involved 404 patients with moderate to severe Alzheimer's disease who were already taking donepezil.
V eni od študij so sodelovali 404 bolniki z zmerno do hudo Alzheimerjevo boleznijo, ki so že prejemali donepezil.
The CHMP considered that the additional analyses provided by the company did not satisfy these concerns.
Odbor CHMP je ugotovil, da dodatne analize, ki jih je predložila družba, ne izključujejo teh zadržkov.
Therefore, the CHMP was of the opinion that the benefits of Acrescent did not outweigh its risks and recommended that it be refused marketing authorisation.
Posledično je odbor CHMP menil, da koristi zdravila Acrescent ne odtehtajo z njim povezanih tveganj, zato je priporočil zavrnitev dovoljenja za promet z zdravilom.
The company informed the CHMP that there are no patients currently included in clinical trials with Acrescent in the European Union.
Družba je odbor CHMP obvestila, da v Evropski uniji v klinična preskušanja zdravila Acrescent trenutno ni vključenih bolnikov.
It presented the results of seven main studies, including patients (or a subset of patients) who received memantine and donepezil together.
Predstavila je rezultate sedmih glavnih študij, v katerih so sodelovali bolniki (ali podskupina bolnikov), ki so prejemali hkratno zdravljenje z memantinom in donepezilom.
Acrescent is a medicine that contains two active substances, memantine hydrochloride and donepezil hydrochloride.
Acrescent je zdravilo, ki vsebuje dve zdravilni učinkovini, memantinijev hidroklorid in donepezilijev hidroklorid.
The effects of adding memantine to donepezil was compared with adding placebo for six months of treatment.
Učinke dodatka memantina k donepezilu so primerjali z dodatkom placeba v šestih mesecih zdravljenja.
The combination of memantine and donepezil is used in some European countries to treat patients with moderate to moderately severe Alzheimer's disease.
Kombinacija memantina in donepezila se v nekaterih evropskih državah uporablja za zdravljenje bolnikov z zmerno do zmerno hudo Alzheimerjevo boleznijo.
Acrescent was expected to be used to treat moderate to moderately severe Alzheimer's disease, in patients who are already taking a daily dose of 20 mg memantine and 10 mg donepezil.
Zdravilo Acrescent naj bi se uporabljalo za zdravljenje zmerne do zmerno hude Alzheimerjeve bolezni pri bolnikih, ki že prejemajo dnevni odmerek 20 mg memantina in 10 mg donepezila.
However, due to the study design it did not demonstrate a clear benefit of the combination treatment, since it did not include a control arm for patients treated with memantine alone.
Kljub temu študija zaradi svoje zasnove ni pokazala jasnih koristi kombiniranega zdravljenja, ker ni vključevala kontrolnega kraka z bolniki, ki so prejemali samo zdravljenje z memantinom.
Acrescent is a combination treatment containing two active substances which are already authorised in the EU to treat the symptoms of Alzheimer's disease.
Zdravilo Acrescent je kombinirano zdravilo z dvema zdravilnima učinkovinama, ki sta v EU že odobreni za zdravljenje simptomov Alzheimerjeve bolezni.
What was Acrescent expected to be used for?
Za kaj naj bi se zdravilo Acrescent uporabljalo?
Memantine works by blocking types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Memantin deluje tako, da zavira vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
The Committee was concerned that the studies presented by the company had negative results except for one main study, in which patients already taking donepezil performed better in cognitive tests and in daily living activities when memantine was added to donepezil treatment.
Odbor je menil, da so rezultati študij, ki jih je predstavila družba, negativni, razen rezultati ene glavne študije, po podatkih katere so bili bolniki, ki so prejemali donepezil, uspešnejši na preskusih kognitivnih sposobnosti in pri izvajanju vsakodnevnih opravil, če so zdravljenju z donepezilom dodali memantin.
The Committee also noted that a published study did not show a significant improvement in patients taking the combination treatment when compared with memantine alone.
Odbor je prav tako navedel, da objavljena študija ni pokazala pomembnega napredka pri bolnikih, ki so prejemali kombinirano zdravljenje, v primerjavi z bolniki, ki so prejemali samo memantin.
By slowing down the breakdown of acetylcholine, donepezil helps to reduce the symptoms of Alzheimer's disease.
Donepezil upočasnjuje razgradnjo acetilholina ter tako pomaga lajšati simptome Alzheimerjeve bolezni.
Donepezil works by blocking the action of an enzyme which normally breaks down a neurotransmitter called acetylcholine.
Donepezil deluje tako, da zavira delovanje encima, ki navadno razgrajuje živčni prenašalec, imenovan acetilholin.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease, and over-activity of the NMDA receptors can result in cell damage or death.
Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršna pri Alzheimerjevi bolezni, prekomerna aktivnost receptorjev
Acetylcholine levels are lower in people suffering from dementia in Alzheimer's disease.
Pri osebah z Alzheimerjevo boleznijo, ki imajo demenco, so ravni acetilholina nižje.
It is authorised to treat patients with moderate to severe forms of Alzheimer's disease.
Učinkovina je odobrena za uporabo pri zdravljenju bolnikov z zmerno do hudo obliko Alzheimerjeve bolezni.
How is Acrescent expected to work?
Kako naj bi zdravilo Acrescent delovalo?
By blocking NMDA receptors, memantine helps to reduce the symptoms of Alzheimer's disease.
Memantin zavira receptorje NMDA ter tako pomaga lajšati simptome Alzheimerjeve bolezni.
What is Acrescent?
Kaj je zdravilo Acrescent?
This summary was last updated in September 2015.
Povzetek je bil nazadnje posodobljen septembra 2015.
This will help protect them against the disease.
To bo živalim pomagalo pri zaščiti pred boleznijo.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zulvac SBV's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Zulvac CBV večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR for Zulvac SBV can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Zulvac SBV je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the EU for Zulvac SBV on 6 February 2015.
Evropska komisija je dovoljenje za promet z zdravilom Zulvac SBV, veljavno po vsej Evropski uniji, izdala 6. februarja 2015.
This is a summary of the European public assessment report (EPAR) for Zulvac SBV.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zulvac SBV.
The animals were vaccinated according to the vaccination schedule and were then exposed to the Schmallenberg virus.
Živali so cepili v skladu s shemo cepljenja in jih nato izpostavili virusu Schmallenberg.
Schmallenberg virus vaccine (inactivated)
cepivo proti virusu Schmallenberg (inaktivirano)
The effectiveness of Zulvac SBV has been investigated in laboratory studies in cattle and sheep.
Učinkovitost cepiva Zulvac SBV so proučevali v laboratorijskih študijah na govedu in ovcah.
When it is given to cattle or sheep, the animals' immune system recognises the virus as foreign and makes antibodies against it.
Ko govedo ali ovce prejmejo cepivo, imunski sistem živali prepozna virus kot „tujek“ in začne proti njemu tvoriti protitelesa.
The withdrawal period for meat from cattle and sheep treated with Zulvac SBV is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso goveda in ovac, zdravljenih z zdravilom Zulvac SBV, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Schmallenberg virus is transmitted by midges and causes stillbirths and birth defects in cattle and sheep.
Virus Schmallenberg prenašajo trzače in povzroča mrtvorojene mladiče ter okvare ploda pri govedu in ovcah.
In the future if the animals are exposed to Schmallenberg virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi živali virusu Schmallenberg v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
In pregnant ewes vaccination reduced viraemia and infection of the embryo.
Pri brejih ovcah se je s cepljenjem zmanjšala viremija in okužba zarodka.
Zulvac SBV contains Schmallenberg virus that has been inactivated so that it cannot cause disease.
Cepivo Zulvac SBV vsebuje virus Schmallenberg, ki je bil inaktiviran in zato ne more povzročiti bolezni.
Zulvac SBV is available as a suspension for injection and can only be obtained with a prescription.
Zdravilo Zulvac SBV je na voljo v obliki suspenzije za injiciranje in se izdaja le na recept.
Zulvac SBV is a veterinary vaccine used to protect cattle and sheep from 3.5 months of age against Schmallenberg virus by reducing viraemia (presence of virus in the blood).
Zulvac SBV je zdravilo za uporabo v veterinarski medicini in se uporablja za zaščito goveda in ovac, starejših od treh mesecev in pol, pred virusom Schmallenberg, saj deluje tako, da zmanjša viremijo (prisotnost virusa v krvi).
Other information about Zulvac SBV:
Druge informacije o zdravilu Zulvac SBV:
Zulvac SBV contains the active substance inactivated (killed) Schmallenberg virus strain BH80/11-4.
Zdravilo Zulvac SBV vsebuje kot zdravilno učinkovino inaktivirani (uničeni) sev virusa Schmallenberg BH80/11-4.
Zulvac SBV is a vaccine.
Zdravilo Zulvac SBV je cepivo.
For female sheep vaccination should be at least two weeks before breeding to reduce viraemia (virus in the blood) and infection of the embryo during the first trimester of pregnancy.
Cepljenje ovčjih samic je treba zaključiti vsaj dva tedna pred parjenjem za zmanjšanje viremije (virusa v krvi) in okužbe zarodka v prvem trimesečju brejosti.
In sheep protection starts three weeks after vaccination and lasts six months.
Zaščita pri ovcah se razvije tri tedne po cepljenju in traja šest mesecev.
What is Zulvac SBV and what is it used for?
Kaj je zdravilo Zulvac SBV in za kaj se uporablja?
In cattle protection starts two weeks after vaccination and lasts 12 months.
Zaščita pri govedu se razvije dva tedna po cepljenju in traja 12 mesecev.
For more information about treatment with Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Zulvac SBV naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
What benefits of Zulvac SBV have been shown in studies?
Kakšne koristi je zdravilo Zulvac SBV izkazalo v študijah?
What are the risks associated with Zulvac SBV?
Kakšna tveganja so povezana z zdravilom Zulvac SBV?
For booster vaccination in cattle two injections of 2 ml should be given three weeks apart every 12 months.
Za poživitveno cepljenje goveda je treba injicirati dva odmerka po 2 ml v razmiku treh tednov vsakih 12 mesecev.
For practical information about using Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Zulvac SBV naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For booster vaccination in non-breeding sheep a single injection of 1 ml should be given every six months whilst in female breeding sheep a single injection of 1 ml should be given at least two weeks before breeding.
Za poživitveno cepljenje neplemenskih ovac je treba injicirati en odmerek po 1 ml vsakih šest mesecev, medtem ko je treba pri plemenskih ovčjih samicah enkratni odmerek po 1 ml injicirati vsaj dva tedna pred parjenjem.
The vaccine is given to cattle as two injections of 2 ml into the neck muscle three weeks apart and to sheep as a single injection of 1 ml under the skin behind the elbow.
Cepivo se govedu injicira v dveh odmerkih po 2 ml v vratno mišico v razmiku treh tednov, ovcam pa se injicira v enem odmerku po 1 ml v podkožje za komolčnim sklepom.
The main measure of effectiveness was absence of viraemia following exposure to the virus.The studies showed that Zulvac SBV protects cattle two weeks and sheep three weeks after vaccination.
Študije so pokazale, da cepivo Zulvac SBV zaščiti govedo dva tedna in ovce tri tedne po cepljenju.
In sheep more than one in ten animals may have an increase in body temperature of up to 1.5 °C during the 24 hours after vaccination.
Pri ovcah se lahko pri več kot eni živali od desetih v 24 urah po cepljenju pojavi povišanje telesne temperature za največ 1,5 °C.
Why is Zulvac SBV approved?
Zakaj je bilo zdravilo Zulvac SBV odobreno?
More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, which may last for at least 97 days as granules less than 0.5 cm in diameter.
Pri več kot eni živali od desetih se lahko na mestu injiciranja v podkožju pojavijo otekline ali zatrdline, premera do največ 8 cm, ki lahko v obliki granulomov, premera manj kot 0,5 cm, trajajo najmanj 97 dni.
More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, and swellings less than 2 cm in diameter may last for at least 47 days.
Pri več kot eni živali od desetih se lahko na mestu injiciranja v podkožju pojavijo otekline ali zatrdline, premera do največ 8 cm, otekline, premera manj kot 2 cm, pa lahko trajajo najmanj 47 dni.
In pregnant ewes more than one in ten animals may have an increase in body temperature of up to 0.8 °C during 4 hours after vaccination.
Pri brejih ovcah se lahko pri več kot eni od desetih živali v 4 urah po cepljenju pojavi povišanje telesne temperature do največ 0,8 °C.
In cattle, an increase in body temperature of up to 1.5°C during the 48 hours after vaccination and the appearance of small lumps of up to 0.7 cm in diameter at the vaccination site that resolve within 10 days are very common (seen in more than 1 animal in 10).
Pri govedu sta zelo pogosta (opažena pri več kot eni živali od desetih) povišanje telesne temperature do največ 1,5 °C v 48 urah po cepljenju in pojav manjših zatrdlin, premera do največ 0,7 cm, na mestu cepljenja, ki izginejo v desetih dneh.
How is Zulvac SBV used?
Kako se zdravilo Zulvac SBV uporablja?
How does Zulvac SBV work?
Kako zdravilo Zulvac SBV deluje?
It is not intended to provide practical advice on how to use Zulvac SBV.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
27 January 2011
27. januar 2011
The European Commission issued a decision on 27 January 2011.
Evropska komisija je odločbo izdala dne 27. januarja 2011.
They are available in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and the United Kingdom.
Zdravila so na voljo v naslednjih državah: Avstrija, Belgija, Ciper, Češka, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Luksemburg, Nizozemska, Poljska, Portugalska, Slovaška, Španija, Švedska in Združeno kraljestvo.
Indications restricted following review procedure under Article 31 of Directive 2001/83/EC as amended
Omejitev indikacij po postopku pregleda v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
After re-examination, the Committee confirmed these recommendations on 18 November 2010.
Po ponovnem pregledu je Odbor dne 18. novembra 2010 ta priporočila potrdil.
Why was modafinil reviewed?
Zakaj je bil modafinil pregledan?
Questions and answers on the review of medicines containing modafinil
Vprašanja in odgovori v zvezi s pregledom zdravil, ki vsebujejo modafinil
The Committee recommended that these indications be removed from the product information.
Odbor je priporočil, da se te indikacije izbrišejo iz informacij o zdravilih.
A group of experts on clinical neurosciences was also convened to provide advice.
Sklicana je bila tudi skupina strokovnjakov za klinično nevrološko znanost, da bi podala nasvete.
However, the data from the trials in other disorders did not provide strong evidence to support the use of the product.
Vendar pa podatki iz preskušanj pri drugih motnjah niso zagotovili močnih dokazov v podporo uporabi tega zdravila.
The European Medicines Agency has completed a review of the safety and effectiveness of modafinil.
Evropska agencija za zdravila je končala pregled varnosti in učinkovitosti modafinila.
What is modafinil?
Kaj je modafinil?
The CHMP confirmed the above conclusions after re-examining its opinion.
CHMP je po ponovnem pregledu mnenja potrdil navedene zaključke.
They are available under the following invented names: Modasomil, Modiodal, Provigil and Vigil, and as generic medicines.
Na voljo so pod naslednjimi izmišljenimi imeni: Modasomil, Modiodal, Provigil in Vigil ter kot generična zdravila.
Excessive sleepiness can also happen with no known causes (idiopathic hypersomnia).
Čezmerna zaspanost lahko nastopi tudi brez znanih razlogov (idiopatska hipersomnija).
The exact way modafinil works is not fully understood, but it most likely interacts with some chemicals in the brain called neurotransmitters such as dopamine and norepinephrine.
Natančen način delovanja modafinila še ni povsem znan, vendar najverjetneje medsebojno deluje z nekaterimi kemičnimi snovmi v možganih, imenovanimi živčni prenašalci, kot sta dopamin in norepinefrin.
Because the Committee noted in its review that modafinil has often been used for conditions for which it is not indicated, the companies have also been asked to carry out further studies, including a ‘drug utilisation study' to look at why family doctors prescribe the medicines.
Ker je Odbor med pregledom opazil, da se modafinil pogosto uporablja za zdravljenje stanj, za katera ni indiciran, je družbe pozval, naj izvedejo dodatne študije, vključno s „študijo o uporabi zdravila“, in ugotovijo, zakaj družinski zdravniki predpisujejo ta zdravila.
Modafinil is used to promote wakefulness (help people stay awake).
Modafinil se uporablja za spodbujanje budnosti (ljudem pomaga, da ostanejo budni).
Medicines containing modafinil were first marketed in Europe in 1992.
Zdravila, ki vsebujejo modafinil, so na evropskem trgu od leta 1992.
Once the PhVWP had received and started its assessment of the data, the working party had further concerns about the medicines, and consequently, on 14 May 2009, the UK medicines regulatory agency asked the CHMP to carry out a full assessment of the benefit-risk balance of modafinilcontaining medicines, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Po prejemu in začetku ocenjevanja podatkov je delovna skupina za farmakovigilanco ponovno izrazila zadržke o zdravilu in posledično je britanska regulativna agencija za zdravila dne 14. maja 2009 CHMP zaprosila, naj izvede celotno oceno razmerja med koristmi in tveganji za zdravila, ki vsebujejo modafinil, ter izda mnenje, ali je treba dovoljenja za promet s temi zdravili v Evropski uniji ohraniti, spremeniti, začasno umakniti ali ukiniti.
These include informing healthcare professional of the changes to the product information triggered by this latest review, and putting in place studies looking at the cardiovascular and skin safety of modafinil.
Ti vključujejo obveščanje zdravstvenega osebja o spremembah informacij o zdravilu, ki so nastale po zadnjem pregledu, in zasnovo študij, s katerimi bi preučili srčno-žilno in kožno varnost modafinila.