natgillin/translations-raw huggingface dataset:
It is also used to correct short height in children who have the genetic diseases Turner syndrome and Prader Willi syndrome, and in children who have longstanding kidney problems. 
Uporablja se tudi za uravnavanje nizke rasti pri otrocih z genetskimi obolenji, s Turnerjevim sindromom in Prader Willijevim sindromom ter pri otrocih z dolgotrajnimi težavami z ledvicami.
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for Genotropin to include a new indication for the treatment of stunted growth caused by the long-term use of steroids in children with juvenile idiopathic arthritis. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji so zaprosili, da sprejme odločitev o spremembi dovoljenja za promet z zdravilom Genotropin z vključitvijo nove indikacije za zdravljenje upočasnjene rasti zaradi dolgotrajne uporabe steroidov pri otrocih z juvenilnim idiopatskim artritisom.
Genotropin is used as replacement therapy in children and adults who have a growth hormone deficiency. 
Zdravilo Genotropin se uporablja kot nadomestna terapija pri zdravljenju otrok in odraslih s pomanjkanjem rastnega hormona.
These national marketing authorisations are not affected by this referral. 
Napotitev ne vpliva na ta dovoljenja za promet z zdravilom.
The new indication was the use of Genotropin in children on long-term treatment with steroids for juvenile idiopathic arthritis (JIA), a rare childhood disease causing inflammation of many joints. 
Nova indikacija je bila uporaba zdravila Genotropin pri otrocih, dolgotrajno zdravljenih s steroidi zaradi juvenilnega idiopatskega artritisa (JIA), redke otroške bolezni, ki povzroča vnetje več sklepov.
Genotropin was to be used to improve growth and body composition in children with severe JIA in whom the prolonged use of steroids to help control inflammation had led to a slowing down of growth. 
Zdravilo Genotropin naj bi se uporabljalo za izboljšanje rasti in telesne sestave otrok s hudim JIA, pri katerih je dolgotrajna uporaba steroidov za nadzorovanje vnetij upočasnila rast.
Somatropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes it able to produce growth hormone. 
Izdeluje ga organizem, ki je po prejemu gena (DNK) zmožen proizvajati rastni hormon.
This summary was last updated in 02-2013. 
Povzetek je bil nazadnje posodobljen 02-2013.
• Parkinson's disease. 
• Parkinsonove bolezni.
The dose can then be increased every week until an effective dose is reached. 
Odmerek je mogoče nato povečevati vsak teden, dokler ne dosežemo učinkovitega odmerka.
This medicine is the same as Neupro, which is already authorised in the European Union (EU). 
To zdravilo je enako zdravilu Neupro, ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Leganto on 16 June 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Leganto, veljavno po vsej Evropski uniji, odobrila dne 16. junija 2011.
The same place must not be used again until two weeks later. 
V prihodnjih dveh tednih se ne sme namestiti na isto mesto.
The patch remains on the skin for 24 hours and is then replaced by a new one in a different place. 
Na koži ostane 24 ur, nato pa se nadomesti z novim obližem na drugem mestu.
Leganto is applied once a day at about the same time every day. 
Zdravilo Leganto se namesti enkrat dnevno, vsak dan ob približno istem času.
The full EPAR for Leganto 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 Leganto je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
EPAR summary for the public rotigotine 
Povzetek EPAR za javnost rotigotin
The patients then lose their ability to control their movements reliably. 
Bolniki nato izgubijo sposobnost zanesljivega nadzora nad svojimi gibi.
The strength of patch to use at the start of treatment depends on the type and stage of the disease being treated. 
Jakost obliža, ki ga je treba uporabiti na začetku zdravljenja, je odvisna od vrste in stopnje zdravljene bolezni.
Leganto is used when a specific cause for the disorder cannot be identified. 
Zdravilo Leganto se uporablja, kadar točnega vzroka motnje ni mogoče ugotoviti.
Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours. 
Vsak obliž sprosti 1, 2, 3, 4, 6 ali 8 mg zdravilne učinkovine rotigotin v obdobju 24 ur.
This is a summary of the European public assessment report (EPAR) for Leganto. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Leganto.
Other information about Leganto 
Druge informacije o zdravilu Leganto
Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination. 
Dopamin je prenašalec v tistem delu možganov, ki nadzira gibanje in koordinacijo.
Leganto was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole. 
Zdravilo Leganto je bilo manj učinkovito od ropinirola: izboljšanje je bilo opaženo pri 70 % bolnikov, ki so prejemali ropinirol.
The way rotigotine works in restless legs syndrome is not fully understood. 
Način delovanja rotigotina pri sindromu nemirnih nog ni povsem znan.
• moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. 
• zmernega do hudega sindroma nemirnih nog, tj. motnje, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da bi se znebil neprijetnih, bolečih ali nenavadnih občutkov v telesu, običajno ponoči.
What benefit has Leganto shown during the studies? 
Kakšne koristi je zdravilo Leganto izkazalo med študijami?
In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. 
Pri bolnikih s Parkinsonovo boleznijo začnejo celice, ki proizvajajo dopamin, odmirati, zato se količina dopamina v možganih zmanjša.
For more information about treatment with Leganto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Leganto preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Leganto is used to treat the symptoms of the following diseases in adults: 
Zdravilo Leganto se uporablja za zdravljenje odraslih s simptomi naslednjih bolezni:
Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement. 
Rotigotin zatem stimulira možgane enako kot dopamin, tako da lahko bolniki spet nadzirajo svoje gibe in kažejo manj znakov in simptomov Parkinsonove bolezni, kot so togost in počasnost gibov.
The backing layer of Leganto contains aluminium. 
Vrhnja plast obliža Leganto vsebuje aluminij.
Leganto was more effective than placebo in treating Parkinson's disease. 
Zdravilo Leganto je bilo pri zdravljenju Parkinsonove bolezni učinkovitejše od placeba.
The main measure of effectiveness was the change in symptoms after six months of treatment with a stable dose, measured using two standard scales. 
Glavno merilo učinkovitosti je bila sprememba v simptomih, izmerjena z uporabo dveh standardnih lestvic, po šestih mesecih zdravljenja s stalnim odmerkom.
Leganto must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients. 
Zdravila Leganto ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rotigotin ali katero koli drugo sestavino zdravila.
The studies in advanced disease measured the length of time during the day that the patients recorded as ‘off' (when they had too many Parkinson's disease symptoms to be able to live normally). 
V študijah napredovale bolezni so merili trajanje obdobja v dnevu, ki so ga bolniki označili kot „izklop“ (ko so imeli preveč simptomov Parkinsonove bolezni naenkrat za normalno življenje).
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 Leganto. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Leganto, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine. 
Domneva se, da ga povzročajo težave v načinu delovanja dopamina v možganih, kar pa se lahko izboljša z uporabo rotigotina.
The studies in early-stage disease looked at the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire. 
V študijah zgodnje faze bolezni so proučevali število bolnikov, pri katerih je bilo opazno najmanj 20-odstotno izboljšanje simptomov, kar so ugotovili s standardnim vprašalnikom o simptomih.
What is the risk associated with Leganto? 
Kakšna tveganja so povezana z zdravilom Leganto?
The active substance in Leganto, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine. 
Zdravilna učinkovina zdravila Leganto, rotigotin, je agonist dopamina, kar pomeni, da posnema delovanje dopamina.
Leganto is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective; 
Zdravilo Leganto se uporablja kot samostojno zdravilo v zgodnji fazi bolezni ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v kateri koli fazi bolezni, vključno v poznih fazah, ko začne učinek levodope popuščati;
The company that makes Neupro has agreed that its scientific data can be used for Leganto (‘informed consent'). 
Družba, ki izdeluje zdravilo Neupro, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Leganto („uporaba dokumentacije s soglasjem“).
In early-stage disease, 48 to 52% of the patients using Leganto had an improvement in symptoms, compared with 19 to 30% of those using placebo. 
V zgodnji fazi bolezni je pri 48 do 52 % bolnikov, ki so jemali zdravilo Leganto, prišlo do izboljšanja simptomov v primerjavi z 19 do 30 % tistih, ki so jemali placebo.
Leganto is a range of transdermal patches (patches that deliver a medicine across the skin). 
Zdravilo Leganto je serija transdermalnih obližev (ki dovajajo zdravilo skozi kožo).
The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm. 
Obliž se namesti na suho, čisto, zdravo kožo na trebuhu, stegnu, kolku, boku, ramenu ali nadlakti.
Two of these studies also compared Leganto with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease). 
V dveh od teh študij so zdravilo Leganto primerjali tudi z drugimi agonisti dopamina (ropinirolom v zgodnji fazi bolezni in pramipeksolom pri napredovali bolezni).
In moderate to severe restless legs syndrome, Leganto has been compared with placebo in two main studies involving a total of 963 patients. 
Pri zmernem do hudem sindromu nemirnih nog so zdravilo Leganto primerjali s placebom v dveh glavnih študijah, v katerih je sodelovalo skupaj 963 bolnikov.
The most common side effects with Leganto in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin. 
Najpogostejši neželeni učinki zdravila Leganto pri bolnikih s Parkinsonovo boleznijo (opaženi pri več kot 1 bolniku od 10) so zaspanost, omotica, glavobol, navzeja (slabost), bruhanje in reakcije na mestu nanosa, npr. pordelost, srbečica in vzdraženost kože.
In smaller studies completed later, the effectiveness of Leganto was found to be comparable with ropinirole. 
V manjših študijah, izvedenih naknadno, je bila učinkovitost zdravila Leganto primerljiva z ropinirolom.
In Parkinson's disease, Leganto has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease. 
Pri zdravljenju Parkinsonove bolezni so zdravilo Leganto primerjali s placebom (zdravilom brez zdravilne učinkovine) v štirih študijah, v katerih je sodelovalo 830 bolnikov v zgodnjem stadiju bolezni in 842 bolnikov z napredovalo boleznijo.
The CHMP decided that Leganto's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Leganto večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For the full list of all side effects reported with Leganto, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Leganto, glejte navodilo za uporabo.
Why has Leganto been approved? 
Zakaj je bilo zdravilo Leganto odobreno?
The maximum dose is 8 mg/24 h for early-stage Parkinson's disease and 16 mg/24 h for advanced disease. 
V zgodnji fazi Parkinsonove bolezni je najvišji odmerek 8 mg/24 h, pri napredovali bolezni pa 16 mg/24 h. Pri sindromu nemirnih nog znaša največji odmerek 3 mg/24 h.
To avoid skin burns, Leganto must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm). 
Če je treba pri bolniku opraviti magnetnoresonančno slikanje (MRI) ali kardioverzijo (postopek za ponovno vzpostavitev normalnega srčnega ritma), je treba obliž Leganto odstraniti, da se preprečijo opekline kože.
In advanced Parkinson's disease, patients using Leganto had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Leganto compared with 0.9 h with placebo). 
Pri napredovali Parkinsonovi bolezni se je pri bolnikih, ki so uporabljali zdravilo Leganto, obdobje „izklopa“ skrajšalo bolj (zmanjšanje za 2,1 do 2,7 ure pri uporabi zdravila Leganto v primerjavi s zmanjšanjem za 0,9 ure pri uporabi placeba).
In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, asthenic conditions (conditions such as tiredness, weakness and feeling unwell) and headache. 
Pri bolnikih s sindromom nemirnih nog so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) slabost, reakcije na mestu nanosa, astenična stanja (stanja, kot so utrujenost, šibkost in občutek nelagodja) ter glavobol.
The decrease seen with Leganto was similar to that seen with pramipexole (2.8 h). 
Skrajšanje tega obdobja pri uporabi zdravila Leganto je bilo podobno kot pri uporabi pramipeksola (2,8 ure).
What is Leganto used for? 
Za kaj se zdravilo Leganto uporablja?
In restless legs syndrome, patients using doses of Leganto between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales. 
Pri sindromu nemirnih nog so rezultati obeh lestvic za merjenje simptomov v obeh študijah pokazali, da je prišlo do večjega izboljšanja pri bolnikih, ki so uporabljali zdravilo Leganto v odmerku od 1 do 3 mg/24 h, kot pri tistih, ki so uporabljali placebo.
What is Leganto? 
Kaj je zdravilo Leganto?
How has Leganto been studied? 
Kako je bilo zdravilo Leganto raziskano?
How does Leganto work? 
Kako zdravilo Leganto deluje?
A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson's disease. 
Na začetku zdravljenja zgodnje faze Parkinsonove bolezni je bolnikom v pomoč poseben komplet z obliži štirih različnih jakosti.
Leganto delivers a constant supply of rotigotine through the skin into the bloodstream. 
Zdravilo Leganto skozi kožo v krvni obtok dovaja stalno količino rotigotina.
Two smaller studies comparing Leganto with ropinirole were completed after the medicine's authorisation. 
Po odobritvi zdravila sta bili izvedeni še dve manjši študiji, v katerih so zdravilo Leganto primerjali z ropinirolom.
How is Leganto used? 
Kako se zdravilo Leganto uporablja?
What measures are being taken to ensure the safe and effective use of Spectrila? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Spectrila?
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom multiply, and so its reduction in the blood causes the cells to die. 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom razmnoževanje, zato upad njene ravni v krvi povzroči odmrtje teh celic.
Other information about Spectrila 
Druge informacije o zdravilu Spectrila
The full EPAR and risk management plan summary for Spectrila 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) in povzetek načrta obvladovanja tveganj za zdravilo Spectrila sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available. 
Zdravnik mora zdravilo dati v bolnišničnem okolju, kjer je na voljo oprema za oživljanje.
This is a summary of the European public assessment report (EPAR) for Spectrila. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Spectrila.
It is not intended to provide practical advice on how to use Spectrila. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area. 
Zdravilo Spectrila se daje vsake tri dni z infundiranjem (kapalno infuzijo) v veno, odmerek pa je odvisen od bolnikove starosti in telesne površine.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the 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 Spectrila večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What is Spectrila and what is it used for? 
Kaj je zdravilo Spectrila in za kaj se uporablja?
A risk management plan has been developed to ensure that Spectrila is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Spectrila je bil pripravljen načrt obvladovanja tveganj.
What benefits of Spectrila have been shown in studies? 
Kakšne koristi je zdravilo Spectrila izkazalo v študijah?
What are the risks associated with Spectrila? 
Kakšna tveganja so povezana z zdravilom Spectrila?
Why is Spectrila approved? 
Zakaj je bilo zdravilo Spectrila odobreno?
The cancer cells need this amino acid to grow and 
Rakave celice to aminokislino potrebujejo za rast in
Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine. 
V nasprotju z njimi pa normalne celice lahko proizvajajo lasten asparagin, zato ima zdravilo nanje manjši vpliv.
In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine. 
V študiji s 199 otroki z ALL je bilo zdravilo Spectrila pri zmanjševanju koncentracije asparagina v krvi enako učinkovito kot drugo zdravilo z asparaginazo (obe sta se uporabljali v kombinaciji z drugimi zdravili): zaloge asparagina v krvi so se izpraznile (zmanjšale) pri 95 % bolnikov, zdravljenih z zdravilom Spectrila, in pri 94 % bolnikov, zdravljenih z drugim zdravilom, ki vsebuje asparaginazo.
It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment. 
Prav tako ga ne smemo uporabljati pri bolnikih, ki so kadar koli imeli pankreatitis ali hude krvavitve ali krvne strdke po zdravljenju z asparaginazo.
The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests. 
Najpogostejši neželeni učinki zdravila Spectrila (ki lahko prizadenejo več kot 1 osebo od 10) so alergijske reakcije (vključno z vročinskimi oblivi, izpuščajem, nizkim krvnim tlakom, koprivnico in težavami z dihanjem), driska, slabost, bruhanje, bolečine v trebuhu, utrujenost, otekanje (zaradi nabiranja tekočine), visoka raven sladkorja v krvi in nizka raven albumina (določene vrste beljakovine) v krvi ter druge nenormalne vrednosti krvnih preiskav.
For more information about treatment with Spectrila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Spectrila preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan. 
Kar se tiče tveganj, so neželeni učinki zdravila Spectrila podobni kot pri drugih zdravilih z asparaginazo in so obravnavani v načrtu za zmanjševanje tveganja za to zdravilo.
Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar. 
Čeprav so podatki pri odraslih omejeni, je z asparaginazo dovolj kliničnih izkušenj, zato je pričakovati, da bodo koristi zdravila Spectrila podobne.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, 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 practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Spectrila naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Spectrila is effective at reducing blood asparagine that the cancer cells need to survive. 
Zdravilo Spectrila je učinkovito pri zmanjševanju količine asparagina v krvi, ki ga za preživetje potrebujejo rakave celice.
How does Spectrila work? 
Kako zdravilo Spectrila deluje?
The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems. 
Najresnejši neželeni učinki zdravila Spectrila vključujejo hude alergijske reakcije, krvne strdke, pankreatitis (vnetje trebušne slinavke) in težave z jetri.
Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems. 
Zdravila Spectrila ne smemo uporabljati pri bolnikih, ki so alergični na katero koli zdravilo z asparaginazo, in bolnikih s pankreatitisom (vnetjem trebušne slinavke), hudo jetrno boleznijo ali motnjami strjevanja krvi.