natgillin/translations-raw huggingface dataset:
In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit. 
Približno 80 % IGF-1 je vezanega v kompleksu z IGFBP-3 in acidolabilno podenoto.
Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence 
Pogosti: srčni šum, tahikardija Občasni: kardiomegalija, ventrikularna hipertrofija, insuficienca mitralne zaklopke, insuficienca trikuspidalne zaklopke
Weight increase Weight increase has been observed with mecasermin treatment. 
Ocenjeno je bilo, da se skupni volumen porazdelitve povečuje z zviševanjem odmerka mekazermina.
PHARMACEUTICAL FORM Solution for injection (injection). 
FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra in brezbarvna vodna raztopina.
NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection 
IME ZDRAVILA INCRELEX 10 mg/ml raztopina za injiciranje
Limited information is available on the concentration of unbound IGF-1 after the administration of INCRELEX. 
Podatki o koncentraciji nevezanega IGF-1 po dajanju zdravila INCRELEX so pomanjkljivi.
Pain in muscles has also been seen with mecasermin treatment. 
Pri zdravljenju z mekazerminom so poročali tudi o bolečinah v mišicah.
Sugarcontaining fluids or food should be consumed. 
V tem primeru morate zaužiti tekočino ali hrano, ki vsebuje sladkor.
*Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli. 
*Mekazermin je insulinu podoben rastni faktor-1 (IGF-1), pridobljen s tehnologijo rekombinantne DNA na kulturi celic Escherichia coli.
These conditions should be monitored during INCRELEX treatment. 
Med zdravljenjem z zdravilom INCRELEX je treba to stanje nadzorovati.
INCRELEX should not be given to pregnant or nursing women. 
Nosečnice ali doječe matere zdravila INCRELEX ne smejo uporabljati.
Patients who terminate treatment should also have an echocardiogram. 
Ehokardiogram naj opravijo tudi bolniki, ki prenehajo z zdravljenjem.
Uncommon: Increased weight 
Občasni: povečanje telesne mase
Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration. 
Pri bolnikih, ki so se zdravili z mekazerminom, so poročali o intrakranialni hipertenziji (IH) s papiledemom, motnjami vida, glavoboli, navzeo in/ali bruhanjem, podobno kot pri zdravljenju z GH.
Use a new disposable needle and syringe every time you give a dose. 
Pri vsakem injiciranju odmerka uporabite novo injekcijsko brizgo in iglo za enkratno uporabo.
Injection sites should be rotated to a different site with each injection. 
Zdravilo je treba vsakič injicirati na drugo mesto.
Tell the doctor immediately if you have any of these symptoms. 
V primeru pojava teh simptomov o tem nemudoma obvestite zdravnika.
Thyroid and nutritional deficiencies should be corrected before initiating mecasermin treatment. 
Pred začetkom zdravljenja z mekazerminom je treba odpraviti motnje delovanja ščitnice in podhranjenost.
Renal impairment No studies have been conducted in children with renal impairment. 
Okvara ledvic Pri otrocih z okvaro ledvic študije niso bile izvedene.
The injection site should be changed for each injection (rotate the injection site). 
Mesto injiciranja morate pri vsakem naslednjem injiciranju zamenjati (rotiranje mesta injiciranja).
Postmarketing reports of local allergic reactions were also received. 
V obdobju po začetku trženja zdravila so poročali tudi o pojavu lokalne preobčutljivosti.
Reproductive system Breast enlargement has been observed with mecasermin treatment. 
Reproduktivni sistem Pri zdravljenju z mekazerminom so poročali o povečanju dojk.
The vial contains 4 ml of solution. 
Viala vsebuje 4 ml raztopine.
The injection site should be dry before you inject. 
Ob injiciranju mora biti mesto injiciranja suho.
Common: Melanocytic naevus 
Pogosti: melanocitni nevus
Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1. 
GH in IGF-1 neposredno spodbujata rast in presnovo celic epifiznih plošč.
Common: Thymus hypertrophy 
Pogosti: hipertrofija timusa
Each vial contains 40 mg of mecasermin. 
Ena viala vsebuje 40 mg mekazermina.
Injection site hypertrophy 
Hipertrofija na mestu injiciranja
Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose. 
Pri dveh osebah so zdravljenje z zdravilom INCRELEX prekinili in ga nato niso več uvedli, pri dveh osebah pa se neželeni učinek po ponovni uvedbi zdravljenja z zdravilom INCRELEX v zmanjšanem odmerku ni ponovil.
If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment. 
Med zdravljenjem z zdravilom INCRELEX se morate 2 do 3 ure po injiciranju zdravila INCRELEX izogibati zelo tveganih dejavnosti (npr. intenzivna telesna aktivnost), še posebej na začetku zdravljenja z zdravilom INCRELEX.
Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score 
Povprečje (SD) za spremembo iz pre-Tx P-vrednost za spremembo iz pre-Tx [1] Pre-Tx = pred zdravljenjem, SD = standardna deviacija, SDS = vrednost standardnega odklona [1] P-vrednosti za primerjanje z vrednostmi pre-Tx so bile izračunane s pomočjo parnega t-testa.
If you develop any of these events, please follow the advice given for each event in the sections below. 
V primeru pojava kateregakoli od navedenih neželenih učinkov upoštevajte navodila, navedena v nadaljevanju.
Common: Papilloedema 
Pogosti: papiledem
Uncommon: Injection site rash, injection site swelling, lipohypertrophy 
Občasni: izpuščaj na mestu injiciranja, oteklina na mestu injiciranja, lipohipertrofija
Papilloedema 
Nadlaket
• Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth. 
• Pri bolnikih, ki začno hitro rasti, se lahko pojavita zdrs epifize glavice stegnenice in napredovanje skolioze.
Enlarged tonsils/adenoids 
Povečanje tonzil/adenoidnega tkiva
Common: Cardiac murmur, tachycardia 
Pogosti: skolioza, mialgija
There were also reports of local allergic reactions at the injection site. 
Poročali so tudi o pojavu lokalnih alergijskih reakcij na mestu injiciranja, najpogosteje o srbenju in urtikariji.
Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment. 
Pri zdravljenju z mekazerminom so poročali o zadebelitvi kože, pojavu kožnih znamenj in nenormalne teksture las.
A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin. 
Za vse ženske v rodni dobi je priporočljivo, da pred začetkom zdravljenja z mekazerminom opravijo test nosečnosti in da je le-ta negativen.
Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product. 
Med uporabo tega zdravila so poročali o pojavu hipertrofije limfatičnega tkiva (npr. tonzilarnega) in zapletih povezanih s tem, kot so smrčanje, apneja v spanju in kronični izcedek iz srednjega ušesa.
A negative pregnancy test and adequate contraception is required in all pre-menopausal women receiving INCRELEX. 
Vse ženske v rodni dobi morajo pred začetkom zdravljenja imeti negativen test nosečnosti, med zdravljenjem z zdravilom INCRELEX pa morajo uporabljati učinkovito kontracepcijo.
Very common: Otitis media Common: Hypoacusis, ear pain, middle ear effusion 
Pogosti: naglušnost, bolečina v ušesih, izliv v srednjem ušesu
Heart abnormalities A fast heart rate and abnormal heart sounds have been reported with mecasermin treatment. 
Nepravilnosti srca Pri zdravljenju z mekazerminom so poročali o hitrem bitju srca in nepravilnih srčnih zvokih.
There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients. 
Pri tej specifični skupini bolnikov s hudim primarnim pomanjkanjem IGF je podatkov glede farmakokinetike mekazermina pri otrocih z okvaro jeter malo.
Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion. 
Odmerki so se v splošnem gibali od 60 do 120 g/kg dvakrat na dan. Bolniki so bili vključeni v študije na osnovi ekstremno nizke telesne višine, počasne rasti, nizkih koncentracij IGF-1 v serumu in normalnega izločanja GH. Pred vključitvijo v študijo se 83 od 92 bolnikov predhodno še ni zdravilo z zdravilom INCRELEX.
Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious. 
V primeru pojava krčev ali nezavesti takoj prenehajte uporabljati zdravilo INCRELEX in nemudoma poiščite nujno zdravniško pomoč.
Hold the syringe and vial firmly (see Figure 
Brizgo in vialo dobro primite (glejte sliko 3).
Nervous system Headache has occurred with mecasermin treatment. 
Živčevje Pri zdravljenju z mekazerminom so poročali o glavobolu.
The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day. 
Običajni odmerek je od 0,04 do 0,12 mg/kg bolnikove telesne mase dvakrat na dan. Glejte “Navodila za uporabo” na koncu tega navodila.
Each ml contains 10 mg of mecasermin*. 
En mililiter vsebuje 10 mg mekazermina*.
Each vial contains 4 ml of solution. 
Ena viala vsebuje 4 ml raztopine.
In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported. 
Po prihodu zdravila na trg so pri bolnikih, ki so se zdravili z zdravilom INCRELEX, poročali o primerih preobčutljivosti, urtikarije, pruritusa in eritema, ki so se lahko pojavili sistemsko in/ali lokalno na mestu injiciranja.
Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use. 
Pri uporabi mekazermina so poročali o generalizirani koprivnici, oteženem dihanju, omotici in otekanju obraza in/ali žrela.
Placental transfer of mecasermin was not studied. 
Prehajanje mekazermina preko posteljice ni bilo raziskano.
Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC). 
Mekazermin pri intravenskih odmerkih 0,25, 1 in 4 mg/dan (do 4-kratna klinična izpostavljenost pri uporabi največjega priporočenega odmerka za človeka na osnovi vrednosti AUC) ni vplival na plodnost podgan.
• To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established. 
• Bolniki bi se morali 2 do 3 ure po dajanju odmerka izogibati visoko tveganim dejavnostim (npr. napornim oblikam fizične aktivnosti), še posebej na začetku zdravljenja z zdravilom INCRELEX, vse dokler se ne ugotovi odmerek zdravila INCRELEX, ki ga bolnik dobro prenaša.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 10 mg of mecasermin. 
NAVEDBA ENE ALI VEČ UČINKOVIN En ml vsebuje 10 mg mekazermina.
Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment. 
Prebavni sistem Pri zdravljenju z mekazerminom so poročali o bolečinah v trebušnem predelu.
Lietuva, Hrvatska Ipsen Pharma Lietuvos filialas 9-ojo Forto 47 
Lietuva, Hrvatska Ipsen Pharma Lietuvos filialas 9-ojo Forto 47LT-48100 Kaunas Tel. + 370 37 337854
Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment. 
Pri zdravljenju z mekazerminom so poročali o hipakuzi (naglušnosti), bolečini v ušesu in tekočini v srednjem ušesu.
Biotransformation Both the liver and the kidney have been shown to metabolise IGF-1. 
Biotransformacija IGF-1 se presnavlja v jetrih in v ledvicah.
Benzyl alcohol Sodium chloride Polysorbate 20 
6.1 Seznam pomožnih snovi benzilalkohol natrijev klorid polisorbat 20 koncentrirana ocetna kislina (ledocet) natrijev acetat voda za injekcije
An increased incidence of mammary gland carcinoma in both male and female rats was observed in animals treated with 10 mg/kg/day (7 times the exposure with the MRHD based on AUC). 
Pri samcih in samicah podgan so pri odmerkih 10 mg/kg/dan (7-kratna izpostavljenost človeka pri klinični uporabi najvišjega priporočenega odmerka na osnovi AUC) opazili večjo pojavnost karcinoma mlečne žleze.
Tell the doctor if you develop hearing problems. 
Če se pojavijo težave s sluhom, o tem obvestite zdravnika.
Eighty-three (83) out of 92 patients were naïve to INCRELEX at baseline and 81 completed at least one year of INCRELEX treatment. 
Vsaj 1-letno zdravljenje z zdravilom INCRELEX je bilo dokončano pri 81 bolnikih.
All 4 subjects recovered from the event without sequelae. 
Pri vseh štirih osebah je stanje izzvenelo brez posledic.
An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day ( 4 times the exposure with the MRHD based on AUC). 
Pri samcih podgan so pri odmerkih 4 in 10 mg/kg/dan ( 4-kratna izpostavljenost človeka pri klinični uporabi najvišjega priporočenega odmerka na osnovi AUC) opazili večjo pojavnost keratoakantomov na koži.
Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX. 
Če so bolniki neposredno pred ali po uporabi zdravila INCRELEX zaužili obrok hrane ali prigrizek, se simptomi hipoglikemije običajno niso pojavili.
Release the skin (see Figure A). 
Iglo zabodite, kot vam je pokazal zdravnik in nato kožo sprostite (glejte sliko A).
What INCRELEX looks like and contents of the pack INCRELEX is a clear and colourless solution for injection (injection) supplied in a glass vial closed with a stopper and a seal. 
Zdravilo INCRELEX je bistra in brezbarvna raztopina za injiciranje (injekcija).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma
Remove the needle from the vial and replace the protective cap. Do not let the needle touch anything. 
Iglo izvlecite iz viale in nanjo namestite zaščitni pokrovček.
Mecasermin should not be administered to a breast-feeding mother. 
Doječe matere mekazermina ne smejo uporabljati.
Do not inject your dose of INCRELEX if you cannot eat for any reason. 
Če zaradi kateregakoli razloga ne morete jesti, si odmerka zdravila INCRELEX ne smete injicirati.
Reactions including pain, irritation, bleeding, bruising, redness and hardening have been reported with INCRELEX treatment. 
Pri zdravljenju z zdravilom INCRELEX so poročali o pojavu bolečine, draženja, krvavitve, modric, rdečine in zatrdline na mestu injiciranja.
Musculoskeletal and connective Very common: Arthralgia, pain in tissue disorders extremity Common: Scoliosis, myalgia 
Motnje reprodukcije in dojk Pogosti: ginekomastija Splošne težave in spremembe na mestu aplikacije
Digestive system Vomiting and pain in the upper belly have occurred with mecasermin treatment. 
Prebavila Pri zdravljenju z mekazerminom so poročali o pojavu bruhanja in bolečinah v zgornjem delu trebuha.
Upper arm 
Povečanje priželjca
Talk to your doctor or pharmacist before using INCRELEX - if you have a curved spine (scoliosis). 
Pred začetkom uporabe zdravila INCRELEX se posvetujte z zdravnikom ali farmacevtom.
The main measure of effectiveness was the average survival time. 
Glavno merilo učinkovitosti je bil povprečni čas preživetja.
The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996. 
Evropska komisija je dovoljenje za promet z zdravilom Rilutek, veljavno po vsej Evropski uniji, izdala 10. junija 1996.
The full EPAR for Rilutek 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 Rilutek je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
One of these studies was in older patients (over 75) and in patients with advanced disease. 
Ena od teh študij je potekala pri starostnikih (nad 75 let) in pri bolnikih z boleznijo v napredovalem stadiju.
It is available as 50 mg tablets. 
Na voljo je v obliki 50-miligramskih tablet.
The exact way in which it works in ALS is not known. 
Natančen način delovanja učinkovine pri bolezni ALS ni znan.
For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Rilutek preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Rilutek must also not be given to women who are pregnant or breastfeeding. 
Zdravila Rilutek prav tako ne smejo prejemati ženske, ki so noseče ali dojijo.
What benefit has Rilutek shown during the studies? 
Kakšne koristi je zdravilo Rilutek izkazalo med študijami?
The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours). 
Priporočeni odmerek je 100 mg na dan (ki se daje kot ena 50-miligramska tableta vsakih 12 ur).
This is a summary of the European public assessment report (EPAR) for Rilutek. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rilutek.
Other information about Rilutek 
Druge informacije o zdravilu Rilutek
ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis. 
ALS je oblika bolezni motoričnega nevrona, pri kateri se živčne celice, odgovorne za pošiljanje navodil mišicam, postopoma kvarijo, kar povzroči šibkost, uničevanje mišic in paralizo.
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 Rilutek. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day. 
Zdravilo Rilutek v odmerku 50 mg/dan ni bilo bolj učinkovito kot placebo, odmerek 200 mg/dan pa ni bil bolj učinkovit kot odmerek 100 mg/dan.
The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Rilutek večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests. 
Najpogostejši neželeni učinki zdravila Rilutek (pri več kot 1 bolniku od 10) so navzeja (slabost), šibkost in nenormalen test jetrnih funkcij.
What is the risk associated with Rilutek? 
Kakšna tveganja so povezana z zdravilom Rilutek?
Rilutek is used in patients with amyotrophic lateral sclerosis (ALS). 
Zdravilo Rilutek se uporablja pri bolnikih z amiotrofično lateralno sklerozo (ALS).
Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged. 
Zdravilo Riluzol zavira sproščanje glutamata, kar naj bi pomagalo preprečevati uničevanje živčnih celic.
It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate. 
Domnevajo, da lahko uničenje živčnih celic pri bolezni motoričnega nevrona povzroči prevelika količina živčnega prenašalca glutamata.
Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo. 
Glede na skupne rezultate treh študij, ki so trajale 18 mesecev, je bil pri bolnikih, ki so prejemali 100 mg zdravila Rilutek na dan, čas preživetja približno 2 meseca daljši kot pri tistih, ki so prejemali placebo.
Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation. 
Zdravilo Rilutek se uporablja za podaljševanje življenja bolnika ali časa, ki mu ostane do mehanične ventilacije.
Rilutek is a medicine containing the active substance riluzole. 
Rilutek je zdravilo, ki vsebuje zdravilno učinkovino riluzol.
Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases. 
Zdravljenje z zdravilom Rilutek sme uvesti le zdravnik specialist z izkušnjami z zdravljenjem bolezni motoričnega nevrona.
The medicine was not more effective than placebo in the late stages of ALS. 
V poznih stadijih bolezni ALS zdravilo ni bilo bolj učinkovito kot placebo.
The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo. 
Pri bolnikih, ki so prejemali Rilutek, je bil povprečni čas preživetja znatno daljši kot pri tistih, ki so prejemali placebo.
Why has Rilutek been approved? 
Zakaj je bilo zdravilo Rilutek odobreno?
Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes. 
Zdravila Rilutek ne smejo uporabljati bolniki z boleznimi jeter ali bolniki z nenormalno visokimi ravnmi jetrnih encimov.
Rilutek should not be used in patients with any other form of motor neuron disease. 
Zdravila Rilutek ne bi smeli uporabljati pri bolnikih, ki imajo druge oblike bolezni motoričnega nevrona.
Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months. 
V študijah so bolniki največ 18 mesecev prejemali 50, 100 ali 200 mg zdravila Rilutek na dan.
For the full list of all side effects reported with Rilutek, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rilutek, glejte navodilo za uporabo.
How has Rilutek been studied? 
Kako je bilo zdravilo Rilutek raziskano?
The active substance in Rilutek, riluzole, acts on the nervous system. 
Zdravilna učinkovina zdravila Rilutek je riluzol, ki učinkuje na živčni sistem.
What is Rilutek used for? 
Za kaj se zdravilo Rilutek uporablja?
What is Rilutek? 
Kaj je zdravilo Rilutek?
How is Rilutek used? 
Kako se zdravilo Rilutek uporablja?
How does Rilutek work? 
Kako zdravilo Rilutek deluje?
Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients. 
V treh študijah, ki so vključevale 1 282 bolnikov, so učinek zdravila Rilutek primerjali z učinkom placeba (zdravila brez zdravilne učinkovine).
This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent'). 
Ta odobritev je temeljila na dovoljenju za promet, odobrenem za zdravilo Stalevo leta 2003 (uporaba dokumentacije s soglasjem).
The use of combinations of levodopa and carbidopa is well established, having been in use since the mid-1970s. 
Uporaba kombinacij levodope in karbidope je dobro uveljavljena, in sicer od sredine sedemdesetih let prejšnjega stoletja.
All of the tablets contain 200 mg entacapone. 
Vse tablete vsebujejo 200 mg entakapona.
They should not be used in patients with severe liver problems. 
Zdravilo se ne sme uporabljati pri bolnikih s hudo okvaro jeter.
They are linked with a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about. 
Povezani so z zmanjšanjem učinka levodope, ko bolnik občuti nenadne prehode med stanjem „on“, ko se lahko premika, in stanjem „off“, ko ima težave z gibanjem.