FrancophonIA/ELRC3.0 huggingface dataset:
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Trydonis than with the extemporary combination.
Slovenian: Za glikopironij je bila največja koncentracija v plazmi podobna po dajanju fiksne kombinacije ali trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija,
English: How to store Trydonis
Slovenian: Shranjevanje zdravila Trydonis
English: The daily dose of Trydonis corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Slovenian: Ti učinki so bistveno manj verjetni med uporabo inhaliranih kortikosteroidov kot med uporabo peroralnih kortikosteroidov.
English: • if you have difficulty passing urine.
Slovenian: • če imate težavo z očmi, imenovano glavkom z zaprtim zakotjem; • če imate težave z odvajanjem urina;
English: The long-term co-administration of Trydonis with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Slovenian: niso preučili in se zato ne priporoča (glejte poglavje 4.4).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM CONTAINER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: The combination of Trydonis with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Slovenian: Kombinacija zdravila Trydonis z nekaterimi drugimi zdravili za KOPB ali zdravili, kot so npr. diuretiki (zdravili za odvajanje vode,
English: Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.
Slovenian: Zato vam bo zdravnik morda občasno spremljal koncentracijo kalija v krvi; • če imate katero od bolezni jeter ali ledvic;
English: • fungal infections of the throat or of the food pipe (oesophagus)
Slovenian: • glivične okužbe žrela ali požiralnika;
English: • trembling
Slovenian: Trydonis.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Slovenian: Natančen način delovanja levetiracetama še vedno ni pojasnjen, toda zdi se, da vpliva na beljakovino, imenovano sinaptični vezikularni protein 2A, ki se nahaja v prostoru med živčnimi celicami in zavira sproščanje kemičnih prenašalcev iz živčnih celic.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Matever on 03 October 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Matever, veljavno po vsej Evropski uniji, odobrila dne 03. oktobra 2011.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Slovenian: To je vrsta epilepsije, pri kateri prevelika električna aktivnost na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
English: What are the benefits and risks of Matever?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Matever?
English: The full EPAR for Matever 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 Matever je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Matever, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Matever preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Slovenian: Na voljo je v obliki tablet (250 mg, 500 mg, 750 mg in 1 000 mg) in v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno, 100 mg/ml).
English: This means that Matever is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Slovenian: Manjši odmerki se uporabljajo pri bolnikih, ki imajo težave z delovanjem ledvic (na primer starejši bolniki).
English: This is a summary of the European public assessment report (EPAR) for Matever.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Matever.
English: This helps Matever to stabilise electrical activity in the brain and prevent seizures.
Slovenian: To omogoča zdravilu Matever, da stabilizira električno aktivnost v možganih in prepreči napade.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Slovenian: • primarno generaliziranih tonično-kloničnih napadov (daljših napadov, vključno z izgubo zavesti) pri bolnikih od 12. leta starosti dalje z idiopatsko generalizirano epilepsijo (vrsto epilepsije, za katero se domneva, da je genetskega izvora).
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 Matever.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Matever, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Matever tablets are swallowed with liquid.
Slovenian: Tablete Matever je treba pogoltniti s tekočino.
English: Because Matever is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Matever generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Committee recommended that Matever be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Matever odobri dovoljenje za promet.
English: Matever can also be used as an add-on to other anti-epileptic medicines to treat:
Slovenian: Zdravilo Matever se lahko uporablja kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
English: The active substance in Matever, levetiracetam, is an anti-epileptic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Matever, levetiracetam, je zdravilo proti epilepsiji.
English: Other information about Matever
Slovenian: Druge informacije o zdravilu Matever:
English: The daily dose can be increased up to 1500 mg twice a day.
Slovenian: Dnevni odmerek se lahko poveča do največ 1 500 mg dvakrat na dan.
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Slovenian: Pri otrocih od šestega meseca do 17. leta starosti, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg/kg telesne mase dvakrat dnevno, ki ga je mogoče povečati vse do 30 mg/kg telesne mase dvakrat dnevno.
English: Why has Matever been approved?
Slovenian: Zakaj je bilo zdravilo Matever odobreno?
English: Because Matever is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Slovenian: Ker je zdravilo Matever generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Keppra.
English: Matever can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible.
Slovenian: Zdravilo Matever se lahko daje kot infuzija v enakih odmerkih in enako pogosto, kadar uporaba tablet ali peroralne raztopine ni mogoča.
English: Matever is a medicine that contains the active substance levetiracetam.
Slovenian: Matever je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
English: 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.
Slovenian: 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.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri referenčnem zdravilu Keppra, odtehtajo znana tveganja.
English: EPAR summary for the public levetiracetam
Slovenian: Povzetek EPAR za javnost
English: Matever is a ‘generic medicine'.
Slovenian: Zdravilo Matever je generično zdravilo.
English: 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.
Slovenian: 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.
English: The CHMP concluded that, in accordance with EU requirements, Matever has been shown to have comparable quality and to be bioequivalent to Keppra.
Slovenian: 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.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Slovenian: • miokloničnih napadov (kratkih, krču podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od starosti 12 let dalje;
English: How has Matever been studied?
Slovenian: Kako je bilo zdravilo Matever raziskano?
English: What is Matever used for?
Slovenian: Za kaj se zdravilo Matever uporablja?
English: What is Matever?
Slovenian: Kaj je zdravilo Matever?
English: How is Matever used?
Slovenian: Kako se zdravilo Matever uporablja?
English: 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.
Slovenian: 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.
English: How does Matever work?
Slovenian: Kako zdravilo Matever deluje?
English: This summary was last updated on 16 April 2009.
Slovenian: Ta povzetek je bil nazadnje posodobljen dne 16 aprila 2009.
English: The vaccine also contains an ‘adjuvant' (mineral oil) to stimulate a better response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ (mineralno olje) za spodbujanje boljšega odziva.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Slovenian: Cepiva delujejo tako, da „učijo“ imunski sistem (naravno obrambo telesa), kako se braniti pred boleznimi.
English: Swelling after the first vaccination normally resolves within 30 days, and may last at least 35 days following the second vaccination.
Slovenian: Po prvem cepljenju oteklina običajno uplahne v 30 dneh in lahko traja najmanj 35 dni po drugem cepljenju.
English: Other information about Netvax:
Slovenian: Druge informacije o zdravilu Netvax:
English: 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.
Slovenian: Shemo cepljenja sestavljata dva odmerka: prvi odmerek se daje pri 10. do 14. tednu starosti, drugi pa štiri do 10 tednov po prvem odmerku.
English: The vaccine protected the chicks during the early period of life, when they are at greatest risk of the disease.
Slovenian: Cepivo je zaščitilo piščance v zgodnjem obdobju življenja, ko je tveganje za razvoj bolezni največje.
English: If pain persists for more than 12 hours after examination, seek medical advice again.
Slovenian: Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom.
English: What benefit has Netvax shown during the studies?
Slovenian: Kakšne koristi je zdravilo Netvax izkazalo med študijami?
English: Netvax is a vaccine.
Slovenian: Zdravilo Netvax je cepivo.
English: The CVMP recommended that Netvax should be given a marketing authorisation.
Slovenian: CVMP je priporočil, da se za zdravilo Netvax odobri dovoljenje za promet.
English: Vaccination causes swelling at the site of injection.
Slovenian: Cepljenje povzroči oteklino na mestu injiciranja.
English: The studies showed that the vaccine is effective in stimulating the production of antibodies in chickens and in their eggs.
Slovenian: Študije so pokazale, da je cepivo učinkovito pri spodbujanju proizvodnje protiteles pri kokoših in njihovih jajcih.
English: Netvax is used to reduce the number of deaths, and the incidence and severity of the disease.
Slovenian: Zdravilo Netvax se uporablja za zmanjšanje števila poginov ter pojavnosti in resnosti bolezni.
English: Birds with the disease fail to thrive.
Slovenian: Ptice s to boleznijo se ne razvijajo.
English: The effectiveness of Netvax has been studied in several trials under laboratory and field conditions in chickens and their chicks.
Slovenian: Učinkovitost zdravila Netvax so raziskovali v številnih preskušanjih v laboratorijskih in terenskih razmerah pri kokoših in njihovih potomcih.
English: Accidental injection of Netvax can cause severe pain and swelling, particularly if it is accidentally injected into a joint or finger.
Slovenian: Nenamerno injiciranje zdravila Netvax lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Slovenian: Razmerje med koristmi in tveganji je na voljo v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Netvax to Intervet International B.V. on 16 April 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Netvax, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
English: What is the risk associated with Netvax?
Slovenian: Kakšna tveganja so povezana z zdravilom Netvax?
English: The studies compared chickens vaccinated with Netvax with birds that did not receive the vaccine.
Slovenian: V študijah so primerjale kokoši, cepljene z zdravilom Netvax, s tistimi, ki cepiva niso prejele.
English: Necrotising enteritis is a disease that causes damage to the gut.
Slovenian: Nekrotični enteritis je bolezen, ki poškoduje prebavni sistem.
English: The antibodies are transferred from the chicken to the chicks via the eggs.
Slovenian: Protitelesa se prenašajo s kokoši na njihove potomce prek jajc.
English: Netvax is given by injection into the breast muscle.
Slovenian: Zdravilo Netvax se injicira v prsno mišico.
English: The main measure of effectiveness was the production of protective antibodies against C. perfringens type A in the chickens' blood and in their eggs.
Slovenian: Glavno merilo učinkovitosti je bila proizvodnja zaščitnih protiteles proti C. perfringens tipa A v krvi in jajcih kokoši.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NETVAX EPAR summary for the public
Slovenian: EMEA/V/C/134 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NETVAX Povzetek EPAR za javnost
English: Why has Netvax been approved?
Slovenian: Zakaj je bilo zdravilo Netvax odobreno?
English: This second dose should be given at least six weeks before the hen will start to lay eggs.
Slovenian: Drugi odmerek je treba dati najmanj šest tednov pred nesnostjo.
English: The hen can continue to pass on immunity to her chicks for almost a year after the end of vaccination.
Slovenian: Kokoš lahko še skoraj eno leto po koncu cepljenja prenaša odpornost na svoje potomce.
English: 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.
Slovenian: 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.
English: If accidental injection happens, seek prompt medical advice and show the package leaflet to the doctor.
Slovenian: Ob nenamernem injiciranju se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo.
English: 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.
Slovenian: Pri piščancih, ki so jih izlegle cepljene kokoši, je cepivo zmanjšalo število poginov in pojavnost ter resnost okvar, ki jih je povzročil nekrotični enteritis.
English: 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.
Slovenian: 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.
English: How has Netvax been studied?
Slovenian: Kako je bilo zdravilo Netvax raziskano?
English: 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.
Slovenian: 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.
English: Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid.
Slovenian: Zdravilo Netvax vsebuje eno obliko toksoida bakterije C. perfringens, imenovano alfa toksoid.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ta protitelesa pomagajo kokošim pri boju proti nekrotičnemu enteritisu, ki ga povzroča C. perfringens tipa A, če so po izvalitvi izpostavljeni tej bakteriji.
English: What is Netvax used for?
Slovenian: Za kaj se zdravilo Netvax uporablja?
English: 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.
Slovenian: 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.
English: What is Netvax?
Slovenian: Kaj je zdravilo Netvax?
English: The vaccine was well tolerated by the chickens, with no effect on the production of eggs or chicks.
Slovenian: Cepivo ni vplivalo na izleganje jajc ali potomcev, kokoši pa so ga dobro prenašale.
English: How does Netvax work?
Slovenian: Kako zdravilo Netvax deluje?
English: The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.
Slovenian: Odmerek je 120 mg dvakrat na dan prvih sedem dni, nato pa se poveča na 240 mg dvakrat na dan.
English: Tecfidera dimethyl fumarate
Slovenian: Tecfidera dimetilfumarat
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tecfidera on 30 January 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tecfidera, veljavno po vsej Evropski uniji, izdala dne 30. januarja 2014.
English: The full EPAR for Tecfidera 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 Tecfidera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tecfidera is available as oral capsules (120 and 240 mg) to be taken with food.
Slovenian: Zdravilo Tecfidera je na voljo v obliki peroralnih kapsul (120 in 240 mg), ki se jemljejo skupaj s hrano.
English: 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.
Slovenian: 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.
English: What measures are being taken to ensure the safe and effective use of Tecfidera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tecfidera?
English: This is a summary of the European public assessment report (EPAR) for Tecfidera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tecfidera.
English: These side effects tend to start early during treatment, usually in the first month, and may continue intermittently throughout treatment.
Slovenian: Ti neželeni učinki se najpogosteje pojavijo v zgodnjem obdobju zdravljenja, običajno v prvem mesecu, in se lahko nato občasno pojavljajo ves čas zdravljenja.
English: Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Slovenian: Tecfidera je zdravilo, ki vsebuje zdravilno učinkovino dimetilfumarat.
English: Other information about Tecfidera
Slovenian: Druge informacije o zdravilu Tecfidera
English: In addition, a number of studies with Tecfidera are planned or underway to provide further long-term safety data and to monitor the medicine.
Slovenian: Poleg tega se načrtujejo ali že izvajajo številne študije z zdravilom Tecfidera, namenjene pridobitvi dodatnih podatkov o dolgoročni varnosti in spremljanju zdravila.