natgillin/translations-raw huggingface dataset:
How does Victoza work?
Kako zdravilo Victoza deluje?
Victoza contains the active substance liraglutide.
Zdravilo Victoza vsebuje zdravilno učinkovino liraglutid.
Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.
Zdravljenje z dvema zdraviloma, ki je vključevalo kombinacijo zdravila Victoza in metformina ali glimepirida, je zmanjšalo ravni HbA1c za približno 1 odstotno točko, medtem ko pri zdravljenju, ki ni vključevalo zdravila Victoza, zmanjšanja ni bilo.
In two ‘triple therapy' studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti-diabetes medicine instead of Victoza.
v dveh študijah zdravljenja s tremi zdravili so zdravilo Victoza v kombinaciji z metforminom ter bodisi glimepiridom ali roziglitazonom (tiazolidindionom) primerjali z zdravljenjem, ki je vključevalo placebo ali drugo zdravilo za zdravljenje sladkorne bolezni namesto zdravila Victoza.
The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg.
Po najmanj enem tednu se odmerek poveča na 1,2 mg.
Victoza used on its own was more effective at controlling blood glucose than glimepiride.
Zdravilo Victoza je bilo kot samostojno zdravilo pri nadzoru ravni glukoze v krvi učinkovitejše od glimepirida.
How is Victoza used?
Kako se zdravilo Victoza uporablja?
In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin.
V drugi študiji zdravljenja s tremi zdravili so zdravilo Victoza primerjali z enkratnim odmerkom insulina s kratkotrajnim delovanjem, tj. insulina asparta, pri čemer so oba dodajali kombinaciji bazalnega insulina in metformina.
In two ‘dual therapy' studies, Victoza plus metformin or Victoza plus glimepiride were compared with metformin or glimepiride taken with a placebo (a dummy treatment).
V dveh študijah zdravljenja z dvema zdraviloma so zdravilo Victoza v kombinaciji z metforminom ali zdravilo Victoza v kombinaciji z glimepiridom primerjali z metforminom ali glimepiridom, ki so ju bolniki jemali v kombinaciji s placebom (zdravilom brez zdravilne učinkovine).
When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).
mora zdravnik razmisliti o zmanjšanju odmerka teh zdravil, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni glukoze v krvi).
In one ‘monotherapy' study, Victoza on its own was compared with glimepiride (a sulphonylurea).
V eni študiji zdravljenja z enim zdravilom so zdravilo Victoza, ki so ga bolniki jemali kot samostojno zdravilo, primerjali z glimepiridom (sulfonilsečnino).
The use of the infusion should be temporary.
Infuzijo je treba uporabljati le začasno.
The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000.
Evropska komisija je dovoljenje za promet z zdravilom Keppra, veljavno po vsej Evropski uniji, odobrila dne 29. septembra 2000.
In all of these studies, the main measure of effectiveness was the change in the number of seizures before and during treatment.
V vseh teh študijah je bilo glavno merilo učinkovitosti sprememba števila napadov pred zdravljenjem in med njim.
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.
Natančen način delovanja levetiracetama še vedno ni pojasnjen, toda zdi se, da vpliva na beljakovino, imenovano sinaptični vezikularni protein 2A, ki se nahaja v predelih med živčnimi celicami in sodeluje pri sproščanju kemičnih prenašalcev iz živčnih celic.
All of the patients were taking at least one other anti-epileptic medicine.
Vsi bolniki so jemali še najmanj eno drugo zdravilo proti epilepsiji.
The full EPAR for Keppra 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 Keppra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Secondary generalisation occurs when the overactivity later reaches the whole brain.
Sekundarna generalizacija se pojavi, ko prekomerno delovanje čez čas zajame celotne možgane.
Epilepsy is caused by excessive electrical activity in the brain.
Epilepsijo povzroča prekomerna električna dejavnost v možganih.
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.
To je vrsta epilepsije, pri kateri prevelika električna aktivnost na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi določenega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
The oral solution may be mixed in a glass of water before it is taken.
Peroralno raztopino lahko pred zaužitjem zmešamo s kozarcem vode.
In both groups, 73% of the patients experienced no seizures for six months once on an adequate dose.
V obeh skupinah je bilo 73 % bolnikov brez napadov šest mesecev od začetka prejemanja ustreznega odmerka.
The study measured how many patients remained free of seizures for six months once they had reached their effective dose.
V študiji so beležili, koliko bolnikov je bilo brez napadov v obdobju šest mesecev od takrat, ko so dosegli učinkovit odmerek.
The CHMP decided that Keppra's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Keppra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This helps Keppra to stabilise electrical activity in the brain and prevent seizures.
To omogoča zdravilu Keppra, da stabilizira električno aktivnost v možganih in prepreči napade.
However, there were too few patients aged below 12 years to support the use of Keppra for this type of seizure in this age group.
Vendar pa je bilo otrok, mlajših od 12 let, premalo, da bi bila potrjena uporaba zdravila Keppra za to vrsto napadov pri bolnikih v tej starostni skupini.
Lower doses are used in patients who have problems with their kidneys (such as older patients).
Manjši odmerki se uporabljajo pri bolnikih, ki imajo težave z delovanjem ledvic (na primer pri starejših bolnikih).
This document is a summary of the European public assessment report (EPAR) for Keppra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Keppra.
For more information about treatment with Keppra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Keppra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
• partial-onset seizures with or without generalisation in patients from one month of age;
• napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih, starejših od enega meseca;
Other information about Keppra:
Druge informacije o zdravilu Keppra:
Keppra tablets are swallowed with liquid.
Tablete Keppra je treba pogoltniti s tekočino.
It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Na voljo je v obliki tablet (250 mg, 500 mg, 750 mg in 1 000 mg), peroralne raztopine (100 mg/ml) in koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno, 100 mg/ml).
The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Peroralna raztopina se priporoča na začetku zdravljenja otrok, ki so mlajši od šest let ali tehtajo manj kot 25 kg.
What benefit has Keppra shown during the studies?
Kakšne koristi je zdravilo Keppra izkazalo med študijami?
• in partial-onset seizures, it has been studied in three main studies in a total of 904 patients aged 16 years and over.
• pri napadih parcialnega izvora, in sicer v treh glavnih študijah pri skupno 904 bolnikih, starih 16 let in več.
Keppra has also been compared with placebo in 314 patients aged between one month and 17 years;
Zdravilo Keppra so primerjali tudi s placebom pri 314 bolnikih, starih od enega meseca do 17 let;
• 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).
• primarno generaliziranih tonično-kloničnih napadov (daljših napadov, vključno z izgubo zavesti) pri bolnikih, starejših od 12 let, z idiopatsko generalizirano epilepsijo (vrsto epilepsije, za katero se domneva, da je genetskega izvora).
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 Keppra.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Keppra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This can be increased up to 21 mg/kg twice a day.
Ta se lahko poveča do 21 mg/kg dvakrat na dan.
The most common side effects with Keppra (seen in more than 1 patient in 10) are nasopharyngitis (inflammation of the nose and throat), somnolence (sleepiness), and headache.
Najpogostejši neželeni učinki zdravila Keppra (opaženi pri več kot 1 bolniku od 10) so nazofaringitis (vnetje nosu in grla), zaspanost in glavobol.
As an add-on treatment, Keppra was more effective than placebo:
Kot dopolnilno zdravljenje je bilo zdravilo Keppra učinkovitejše od placeba:
Keppra must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Zdravila Keppra ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) levetiracetam ali druge pirolidonske derivate (zdravila s podobno zgradbo kot levetiracetam) ali na katero koli drugo sestavino zdravila.
Keppra was also more effective than placebo in children;
Zdravilo Keppra je bilo učinkovitejše od placeba tudi pri otrocih;
With Keppra at a dose of 2,000 mg, the reduction was 27%, and with 3,000 mg, it was around 39%.
Z zdravilom Keppra v odmerku 2 000 mg se je število napadov zmanjšalo za 27 %, v odmerku 3 000 mg pa za okoli 39 %.
What is the risk associated with Keppra?
Kakšna tveganja so povezana z zdravilom Keppra?
In these studies, Keppra at doses of 1,000, 2,000 or 3,000 mg per day, was compared with placebo (a dummy treatment) over 12 to 14 weeks.
V teh študijah so zdravilo Keppra v odmerkih 1 000 mg, 2 000 mg ali 3 000 mg na dan primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 12 do 14 tednov.
• for partial onset seizures, placebo treatment reduced the weekly number of seizures by 6 to 7%, while the reduction with Keppra at a dose of 1,000 mg per day was between 18 and 33%, depending on the study.
• pri napadih parcialnega izvora, pri katerih je zdravljenje s placebom tedensko število napadov zmanjšalo za 6 do 7 %, medtem ko je zdravljenje z zdravilom Keppra v odmerku 1 000 mg na dan to število zmanjšalo za 18 do 33 %, odvisno od študije.
• in primary generalised tonic-clonic seizures, Keppra was compared with placebo in 164 patients aged four years or over.
• pri primarno generaliziranih tonično-kloničnih napadih, pri katerih so zdravilo Keppra primerjali s placebom pri 164 bolnikih, starih štiri leta in več.
Keppra is a medicine that contains the active substance levetiracetam.
Keppra je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
For the full list of all side effects reported with Keppra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Keppra, glejte navodilo za uporabo.
Keppra has also been studied as an add-on treatment:
Zdravilo Keppra so proučevali tudi kot dopolnilno zdravljenje:
Keppra can also be used as an add-on to other anti-epileptic medicines to treat:
Zdravilo Keppra se lahko uporablja kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
Keppra 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.
Zdravilo Keppra se lahko daje kot infuzija v enakih odmerkih in enako pogosto, kadar uporaba tablet ali peroralne raztopine ni mogoča.
The active substance in Keppra, levetiracetam, is an anti-epileptic medicine.
Zdravilna učinkovina zdravila Keppra, levetiracetam, je zdravilo proti epilepsiji.
The daily dose can be increased up to 1,500 mg twice a day.
Dnevni odmerek se lahko poveča do največ 1 500 mg dvakrat dnevno.
Why has Keppra been approved?
Zakaj je bilo zdravilo Keppra odobreno?
• for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
• pri miokloničnih napadih, pri katerih se je število dni z napadi na teden prepolovilo pri 58 % bolnikov, ki so prejemali zdravilo Keppra, in 23 % bolnikov, ki so prejemali placebo;
When Keppra 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 Keppra 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.
• in myoclonic seizures, Keppra was studied in 122 patients aged 12 years and over, who received either Keppra or placebo in addition to their normal anti-epileptic medicine for up to 30 weeks;
• pri miokloničnih napadih, in sicer pri 122 bolnikih, starih 12 let in več, ki so do 30 tednov poleg svojega običajnega zdravila proti epilepsiji prejemali zdravilo Keppra ali placebo;
• for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra.
• pri tonično-kloničnih napadih, pri katerih se je število napadov v povprečju zmanjšalo za 28 % pri bolnikih, ki so jemali placebo, v primerjavi s 57 % pri bolnikih, ki so jemali zdravilo Keppra.
The patient's treatment was continued for 20 weeks once they were taking their full dose.
Ko je bolnik začel prejemati celotni odmerek, se je njegovo zdravljenje nadaljevalo do 20 tednov.
Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
Zdravilo Keppra kot samostojno zdravilo so proučevali pri 579 bolnikih z napadi parcialnega izvora, starih 16 let in več, ki so do dve leti prejemali zdravilo Keppra ali karbamazepin (drugo zdravilo proti epilepsiji).
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.
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, lahko pa se poveča vse do 30 mg/kg telesne mase dvakrat dnevno.
• 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 12. leta starosti dalje;
Keppra 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 Keppra se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, ki imajo prvič diagnosticirano epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Pri dojenčkih, starih od enega do šestih mesecev, se daje peroralna raztopina z začetnim odmerkom 7 mg/kg dvakrat na dan.
What is Keppra used for?
Za kaj se zdravilo Keppra uporablja?
What is Keppra?
Kaj je zdravilo Keppra?
How does Keppra work?
Kako zdravilo Keppra deluje?
When Keppra 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 Keppra 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 presledkih do največjega odmerka 1 500 mg dvakrat dnevno.
Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures.
Zdravilo Keppra, uporabljeno kot samostojno zdravilo za napade parcialnega izvora, je bilo pri preprečevanju napadov enako učinkovito kot karbamazepin.
How has Keppra been studied?
Kako je bilo zdravilo Keppra raziskano?
How is Keppra used?
Kako se zdravilo Keppra uporablja?
This summary was last updated in 02-2015.
Povzetek je bil nazadnje posodobljen 02-2015.
This medicine is the same as Renagel, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Renagel, ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Tasermity on 26 February 2015.
Evropska komisija je dovoljenje za promet z zdravilom Tasermity, veljavno po vsej Evropski uniji, izdala 26. februarja 2015.
This leads to phosphate accumulating in the body, which, in the long term, can cause complications affecting the heart and the bones.
Zato se fosfati kopičijo v telesu, kar lahko dolgoročno povzroči zaplete, ki prizadenejo srce in kosti.
This helps to reduce the phosphate levels in the blood.
To pomaga pri zniževanju ravni fosfatov v krvi.
What measures are being taken to ensure the safe and effective use of Tasermity?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tasermity?
The full EPAR for Tasermity 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 Tasermity je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Tasermity.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tasermity.
Other information about Tasermity
Druge informacije o zdravilu Tasermity
Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Bolniki s hudim obolenjem ledvic ne morejo izločiti fosfatov iz telesa.
Tasermity must be taken with meals and patients should keep to their prescribed diets.
Zdravilo Tasermity je treba jemati ob obrokih, bolniki pa se morajo držati predpisane diete.
Tasermity is available as tablets (800 mg).
Zdravilo Tasermity je na voljo v obliki tablet (800 mg).
The most common side effects with Tasermity (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Najpogostejša neželena učinka zdravila Tasermity (ki lahko prizadeneta več kot 1 osebo od 10) sta navzeja (slabost) in bruhanje.
The dose of Tasermity should be adjusted every two to three weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Odmerek zdravila Tasermity je treba prilagoditi vsaka dva do tri tedne, dokler niso dosežene sprejemljive ravni fosfatov v krvi, ki jih je nato treba redno spremljati.
The recommended starting dose of Tasermity is 1 or 2 tablets three times a day, depending on clinical need and the level of phosphate in the blood.
Priporočeni začetni odmerek zdravila Tasermity je ena ali dve tableti trikrat na dan, odvisno od klinične potrebe in ravni fosfatov v krvi.
A risk management plan has been developed to ensure that Tasermity is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Tasermity je bil pripravljen načrt obvladovanja tveganj.
Tasermity should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Zdravilo Tasermity je treba uporabljati sočasno z drugimi zdravili, na primer z dodatki kalcija in vitamina D, da se prepreči razvoj bolezni kosti.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tasermity's benefits are greater than its risks for the treatment of hyperphosphataemia 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 Tasermity pri zdravljenju hiperfosfatemije večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The company that makes Renagel has agreed that its scientific data can be used for Tasermity (‘informed consent').
Družba, ki proizvaja zdravilo Renagel, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Tasermity („uporaba dokumentacije s soglasjem“).
What are the risks associated with Tasermity?
Kakšna tveganja so povezana z zdravilom Tasermity?
What benefits of Tasermity have been shown in studies?
Kakšne koristi je zdravilo Tasermity izkazalo v študijah?
What is Tasermity and what is it used for?
Kaj je zdravilo Tasermity in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasermity, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Tasermity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tasermity preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Tasermity, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Tasermity glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Tasermity.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Lahko se uporablja pri bolnikih, ki potrebujejo hemodializo (z uporabo naprave za filtriranje krvi) ali peritonealno dializo (pri kateri se tekočina črpa v trebuh, notranja telesna membrana pa filtrira kri).
For practical information about using Tasermity, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Tasermity naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Studies have shown that Tasermity significantly reduces blood phosphate levels in patients with kidney disease undergoing dialysis.
Študije so pokazale, da zdravilo Tasermity pomembno zniža ravni fosfatov v krvi pri bolnikih z obolenjem ledvic, ki potrebujejo dializo.