natgillin/translations-raw huggingface dataset:
Matever can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Zdravilo Matever se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, ki imajo na novo diagnosticirano epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri referenčnem zdravilu Keppra, odtehtajo znana tveganja.
EPAR summary for the public levetiracetam
Povzetek EPAR za javnost
Matever is a ‘generic medicine'.
Zdravilo Matever je generično zdravilo.
When Matever is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Kadar se zdravilo Matever dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat na dan.
The CHMP concluded that, in accordance with EU requirements, Matever has been shown to have comparable quality and to be bioequivalent to Keppra.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Matever primerljivo raven kakovosti kot referenčno zdravilo Keppra ter da mu je biološko enakovredno.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
• miokloničnih napadov (kratkih, krču podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od starosti 12 let dalje;
How has Matever been studied?
Kako je bilo zdravilo Matever raziskano?
What is Matever used for?
Za kaj se zdravilo Matever uporablja?
What is Matever?
Kaj je zdravilo Matever?
How is Matever used?
Kako se zdravilo Matever uporablja?
When Matever is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Matever uporablja kot samostojno zdravilo, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan. Odmerki se lahko glede na bolnikov odziv še naprej povečujejo v dvotedenskih razmakih do največjega odmerka 1 500 mg dvakrat na dan.
How does Matever work?
Kako zdravilo Matever deluje?
This summary was last updated on 16 April 2009.
Ta povzetek je bil nazadnje posodobljen dne 16 aprila 2009.
The vaccine also contains an ‘adjuvant' (mineral oil) to stimulate a better response.
Cepivo vsebuje tudi „adjuvans“ (mineralno olje) za spodbujanje boljšega odziva.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da „učijo“ imunski sistem (naravno obrambo telesa), kako se braniti pred boleznimi.
Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.
Po prvem cepljenju oteklina običajno uplahne v 30 dneh in lahko traja najmanj 35 dni po drugem cepljenju.
Other information about Netvax:
Druge informacije o zdravilu Netvax:
The vaccination schedule consists of two doses: the first dose is given at 10 to 14 weeks of age, and then a second dose is given four to 10 weeks after the first.
Shemo cepljenja sestavljata dva odmerka: prvi odmerek se daje pri 10. do 14. tednu starosti, drugi pa štiri do 10 tednov po prvem odmerku.
The vaccine protected the chicks during the early period of life, when they are at greatest risk of the disease.
Cepivo je zaščitilo piščance v zgodnjem obdobju življenja, ko je tveganje za razvoj bolezni največje.
If pain persists for more than 12 hours after examination, seek medical advice again.
Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom.
What benefit has Netvax shown during the studies?
Kakšne koristi je zdravilo Netvax izkazalo med študijami?
Netvax is a vaccine.
Zdravilo Netvax je cepivo.
The CVMP recommended that Netvax should be given a marketing authorisation.
CVMP je priporočil, da se za zdravilo Netvax odobri dovoljenje za promet.
Vaccination causes swelling at the site of injection.
Cepljenje povzroči oteklino na mestu injiciranja.
The studies showed that the vaccine is effective in stimulating the production of antibodies in chickens and in their eggs.
Študije so pokazale, da je cepivo učinkovito pri spodbujanju proizvodnje protiteles pri kokoših in njihovih jajcih.
Netvax is used to reduce the number of deaths, and the incidence and severity of the disease.
Zdravilo Netvax se uporablja za zmanjšanje števila poginov ter pojavnosti in resnosti bolezni.
Birds with the disease fail to thrive.
Ptice s to boleznijo se ne razvijajo.
The effectiveness of Netvax has been studied in several trials under laboratory and field conditions in chickens and their chicks.
Učinkovitost zdravila Netvax so raziskovali v številnih preskušanjih v laboratorijskih in terenskih razmerah pri kokoših in njihovih potomcih.
Accidental injection of Netvax can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
Nenamerno injiciranje zdravila Netvax lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B.V. on 16 April 2009.
Evropska komisija je dovoljenje za promet z zdravilom Netvax, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
What is the risk associated with Netvax?
Kakšna tveganja so povezana z zdravilom Netvax?
The studies compared chickens vaccinated with Netvax with birds that did not receive the vaccine.
V študijah so primerjale kokoši, cepljene z zdravilom Netvax, s tistimi, ki cepiva niso prejele.
Necrotising enteritis is a disease that causes damage to the gut.
Nekrotični enteritis je bolezen, ki poškoduje prebavni sistem.
The antibodies are transferred from the chicken to the chicks via the eggs.
Protitelesa se prenašajo s kokoši na njihove potomce prek jajc.
Netvax is given by injection into the breast muscle.
Zdravilo Netvax se injicira v prsno mišico.
The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens' blood and in their eggs.
Glavno merilo učinkovitosti je bila proizvodnja zaščitnih protiteles proti C. perfringens tipa A v krvi in jajcih kokoši.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NETVAX EPAR summary for the public
EMEA/V/C/134 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NETVAX Povzetek EPAR za javnost
Why has Netvax been approved?
Zakaj je bilo zdravilo Netvax odobreno?
This second dose should be given at least six weeks before the hen will start to lay eggs.
Drugi odmerek je treba dati najmanj šest tednov pred nesnostjo.
The hen can continue to pass on immunity to her chicks for almost a year after the end of vaccination.
Kokoš lahko še skoraj eno leto po koncu cepljenja prenaša odpornost na svoje potomce.
The studies also looked at death rates in the chicks hatched by vaccinated hens, and at the incidence and the severity of lesions caused by necrotic enteritis in the gut after the chicks were deliberately infected with the bacterium at three weeks of age.
V študijah so prav tako raziskovali pogin piščancev, ki so jih izlegle cepljene kokoši in pojavnost ter resnost okvar, ki jih je povzročil nekrotični enteritis v prebavnem sistemu potem, ko so piščance pri treh tednih starosti namenoma okužili z bakterijo.
If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor.
Ob nenamernem injiciranju se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo.
In chicks hatched from vaccinated hens, the vaccine reduced the number of deaths, and the incidence and the severity of lesions caused by necrotic enteritis.
Pri piščancih, ki so jih izlegle cepljene kokoši, je cepivo zmanjšalo število poginov in pojavnost ter resnost okvar, ki jih je povzročil nekrotični enteritis.
Netvax is a vaccine that contains a toxoid (a weakened toxin) from the bacterium Clostridium perfringens (C. perfringens) type A. The vaccine is an emulsion (a mixture of oil- and water-based liquids) for injection.
Zdravilo Netvax je cepivo, ki vsebuje toksoid (oslabljeni toksin) iz bakterije Clostridium perfringens (C. perfringens) tipa A. Cepivo je na voljo v obliki emulzije (mešanice tekočin na osnovi olja in vode) za injiciranje.
How has Netvax been studied?
Kako je bilo zdravilo Netvax raziskano?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Netvax exceed the risks for the active immunisation of chickens, to provide passive immunisation against necrotic enteritis to their progeny, during the laying period, to reduce mortality and the incidence and severity of lesions caused by C. perfringens type A-induced necrotic enteritis.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Netvax za aktivno imunizacijo kokoši proti nekrotičnemu enteritisu med nesnostjo in prenos pasivne zaščite na njihove potomce, za zmanjšanje pogina ter pojavnosti in resnosti okvar pri nekrotičnem enteritisu, ki jih povzroča bakterija C. perfringens tipa A, večje od z njim povezanih tveganj.
Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid.
Zdravilo Netvax vsebuje eno obliko toksoida bakterije C. perfringens, imenovano alfa toksoid.
Netvax contains small amounts of a toxoid from C. perfringens type A. When it is given to a chicken, its immune system recognises the toxoid as ‘foreign' and makes antibodies against it.
Zdravilo Netvax vsebuje majhne količine toksoida bakterije C. perfringens tipa A. Ko z njim cepimo kokoš, njen imunski sistem prepozna toksoid kot „tujek“ in proti njemu ustvari protitelesa.
These antibodies help the chicks to fight necrotic enteritis caused by C. perfringens type A if they are exposed to the bacterium after they have hatched.
Ta protitelesa pomagajo kokošim pri boju proti nekrotičnemu enteritisu, ki ga povzroča C. perfringens tipa A, če so po izvalitvi izpostavljeni tej bakteriji.
What is Netvax used for?
Za kaj se zdravilo Netvax uporablja?
Netvax is used to vaccinate chickens against necrotic enteritis caused by C. perfringens type A, so that they pass their immunity against the disease on to their chicks.
Zdravilo Netvax se uporablja za cepljenje kokoši proti nekrotičnemu enteritisu, ki ga povzroča C. perfringens tipa A, tako da prenesejo odpornost na bolezen na svoje potomce.
What is Netvax?
Kaj je zdravilo Netvax?
The vaccine was well tolerated by the chickens, with no effect on the production of eggs or chicks.
Cepivo ni vplivalo na izleganje jajc ali potomcev, kokoši pa so ga dobro prenašale.
How does Netvax work?
Kako zdravilo Netvax deluje?
The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.
Odmerek je 120 mg dvakrat na dan prvih sedem dni, nato pa se poveča na 240 mg dvakrat na dan.
The European Commission granted a marketing authorisation valid throughout the European Union for Tecfidera on 30 January 2014.
Evropska komisija je dovoljenje za promet z zdravilom Tecfidera, veljavno po vsej Evropski uniji, izdala dne 30. januarja 2014.
The full EPAR for Tecfidera 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 Tecfidera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tecfidera is available as oral capsules (120 and 240 mg) to be taken with food.
Zdravilo Tecfidera je na voljo v obliki peroralnih kapsul (120 in 240 mg), ki se jemljejo skupaj s hrano.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Tecfidera's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Tecfidera večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Tecfidera?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tecfidera?
This is a summary of the European public assessment report (EPAR) for Tecfidera.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tecfidera.
These side effects tend to start early during treatment, usually in the first month, and may continue intermittently throughout treatment.
Ti neželeni učinki se najpogosteje pojavijo v zgodnjem obdobju zdravljenja, običajno v prvem mesecu, in se lahko nato občasno pojavljajo ves čas zdravljenja.
Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Tecfidera je zdravilo, ki vsebuje zdravilno učinkovino dimetilfumarat.
Other information about Tecfidera
Druge informacije o zdravilu Tecfidera
In addition, a number of studies with Tecfidera are planned or underway to provide further long-term safety data and to monitor the medicine.
Poleg tega se načrtujejo ali že izvajajo številne študije z zdravilom Tecfidera, namenjene pridobitvi dodatnih podatkov o dolgoročni varnosti in spremljanju zdravila.
In a second main study involving 1,417 patients, patients were given Tecfidera, placebo or another medicine, glatiramer acetate.
V drugi glavni študiji, v kateri je sodelovalo 1 417 bolnikov, so bolnikom dajali zdravilo Tecfidera, placebo ali drugo zdravilo, imenovano glatiramer acetat.
A risk management plan has been developed to ensure that Tecfidera is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Tecfidera je bil pripravljen načrt obvladovanja tveganj.
It is not intended to provide practical advice on how to use Tecfidera.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The active substance, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2' that regulates certain ‘antioxidant' genes involved in protecting cells from damage.
Zdravilna učinkovina, dimetilfumarat, naj bi delovala tako, da aktivira beljakovino, imenovano „Nrf2“, ki uravnava določene „antioksidativne“ gene, ki pomagajo ščititi celice pred poškodbami.
It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Uporablja se za zdravljenje multiple skleroze (MS), tj. bolezni, pri kateri vnetje uniči zaščitno ovojnico okoli živcev.
The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells and protein in the urine.
Glavna ugotovljena tveganja, povezana z zdravilom Tecfidera, so bila ocenjena kot obvladljiva ter vključujejo vročinske oblive in težave s prebavili (najpogostejši neželeni učinki) ter znižanje ravni belih krvnih celic in beljakovin v urinu.
What is Tecfidera and what is it used for?
Kaj je zdravilo Tecfidera in za kaj se uporablja?
In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Pri multipli sklerozi imunski sistem telesa ne deluje pravilno in napade dele osrednjega živčevja (možgane in hrbtenjačo), s čimer povzroči vnetje, ki poškoduje ovojnico okoli živcev.
What are the risks associated with Tecfidera?
Kakšna tveganja so povezana z zdravilom Tecfidera?
What benefits of Tecfidera have been shown in studies?
Kakšne koristi je zdravilo Tecfidera izkazalo v študijah?
Why is Tecfidera approved?
Zakaj je bilo zdravilo Tecfidera odobreno?
For more information about treatment with Tecfidera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tecfidera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area).
Najpogostejši neželeni učinki zdravila Tecfidera (ki lahko prizadenejo več kot 1 osebo od 10) so vročinski oblivi (rdečina kože) in težave s prebavili (na primer driska, slabost in bolečine v predelu trebuha).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tecfidera, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Tecfidera in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In a main study involving 1,234 patients, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.
V glavni študiji, v kateri je sodelovalo 1 234 bolnikov, je bil delež bolnikov, ki so v obdobju dveh let imeli recidiv, znatno manjši pri zdravljenju z zdravilom Tecfidera kot pri zdravljenju s placebom (zdravilom brez zdravilne učinkovine): 27 % v primerjavi s 46 %.
This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo.
Ta študija je pokazala, da je zdravilo Tecfidera učinkovitejše od placeba pri zmanjšanju števila recidivov v obdobju dveh let: število recidivov na bolnika na leto je bilo približno 0,2 pri zdravljenju z zdravilom Tecfidera in 0,4 pri zdravljenju s placebom.
For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Tecfidera naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The number of relapses per patient per year for glatiramer acetate was 0.3.
Pri zdravljenju z glatiramer acetatom je bilo število recidivov na bolnika na leto 0,3.
Tecfidera can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Izdaja zdravila Tecfidera je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
For the full list of all side effects reported with Tecfidera, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tecfidera, glejte navodilo za uporabo.
Dimethyl fumarate, has been shown in studies to reduce the inflammation and modulate the activity of the immune system.
Študije so pokazale, da dimetilfumarat zmanjša vnetje in uravnava delovanje imunskega sistema.
Tecfidera has been shown to be effective in reducing the number of relapses in patients with relapsingremitting MS and in reducing the number of patients who have relapses during treatment.
Zdravilo Tecfidera se je izkazalo za učinkovito pri zmanjšanju števila recidivov pri bolnikih z recidivno remitentno multiplo sklerozo in pri zmanjšanju števila bolnikov, pri katerih se med zdravljenjem pojavijo recidivi.
It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Zdravilo Tecfidera se uporablja samo pri odraslih z vrsto multiple skleroze, imenovano recidivno remitentna multipla skleroza, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
How does Tecfidera work?
Kako zdravilo Tecfidera deluje?
How is Tecfidera used?
Kako se zdravilo Tecfidera uporablja?
Tecfidera has been shown to reduce the number of relapses in patients with relapsing-remitting MS and to reduce the number of patients who have them.
Študije so pokazale, da zdravilo Tecfidera zmanjša število recidivov pri bolnikih z recidivno remitentno multiplo sklerozo in zmanjša število bolnikov, ki imajo recidive.
The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal problems.
Pri bolnikih, pri katerih se kot neželeni učinki pojavijo vročinski oblivi in težave s prebavili, se lahko odmerek začasno zmanjša.
Those data can be summarised as follows:
Podatke je mogoče povzeti takole:
The conclusions of the study are accepted.
Zaključki študije se sprejmejo.
The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.
Vloga je bila predložena Irski kot referenčni državi članici ter Belgiji, Danski, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, Nizozemski, Portugalski, Španiji in Veliki Britaniji kot zadevnim državam članicam.
The study was conducted at multiple sites in Germany and Spain.
Študija je potekala na več krajih v Nemčiji in Španiji.
Therefore, its use as the positive control is in line with existing guidance and is considered legitimate.
Zato je njegova uporaba kot pozitivna kontrola v skladu z obstoječimi smernicami in legitimna.
Elimination half-life was estimated to be 13.76 + 6.42 hours.
Ocenjeni razpolovni čas izločanja je bil 13,76 + 6,42 ure.
The concerns raised by Denmark remained unsolved and consequently the matter was referred to the CVMP on 21 September 2011.
Tisti pa, ki jih je izrazila Danska, so ostale nerešeni, zato je bila zadeva 21. septembra 2011 napotena na odbor CVMP.
During the decentralised procedure two concerned Member States identified potential serious risks regarding the proposed indications (France) and the efficacy of the product (Denmark).
Med decentraliziranim postopkom sta dve zadevni državi članici opredelili možna resna tveganja v zvezi s predlaganimi indikacijami (Francija) in učinkovitostjo zdravila (Danska).
The isolates on which the MIC data are based were collected from sheep with respiratory tract disease between 2006 and 2010.
Izolati, na katerih temeljijo podatki MIK, so bili pridobljeni pri ovcah z boleznijo dihalnih poti med letoma 2006 in 2010.
This part of the dossier was not assessed in this referral procedure as no concern was notified by the reference Member State nor was any concern raised during the procedure as the dose remains as proposed and concluded by the reference Member State.
Ta del dokumentacije v tem napotitvenem postopku ni bil ocenjen, ker referenčna država članica ni sporočila nobenih skrbi in ker se med postopkom niso pojavile nobene nove skrbi, saj ostaja odmerek enak predlaganemu, o katerem je odločila referenčna država članica.
The warnings in the product literature remain appropriate with the change indicated in section 2.4 below.
Opozorila v literaturi o zdravilu so ustrezna, razen spremembe v poglavju 2.4, ki je navedena spodaj.
During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Med tem postopkom je predlagatelj predložil dodatne podatke in pomisleki, ki jih je izpostavila Francija glede predlaganih indikacij, so bili rešeni.
The adequacy of the treatment interval was one of the main points of discussion during the referral procedure.
V napotitvenem postopku je bila ustreznost intervalov zdravljenja ena od glavnih točk razprave.
No further risk management or mitigation measures are required as a consequence of this referral procedure.
Nadaljnja obvladovanja tveganj ali ukrepi za njihovo zmanjšanje kot posledica tega napotitvenega postopka niso potrebni.