natgillin/translations-raw huggingface dataset:
Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia. 
Kot drugi sekretagogi insulina lahko tudi repaglinid povzroči hipoglikemijo.
The strengths are 0.5 mg, 1 mg and 2 mg. 0.5 mg tablets are white, 1 mg tablets are yellow and 2 mg tablets are peach-coloured. 
Tablete so na voljo v treh jakostih: 0,5 mg, 1 mg in 2 mg. 0,5-mg tablete so bele, 1-mg tablete rumene, 2-mg tablete pa breskove barve.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture 
6.4 Posebna navodila za shranjevanje Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
• Thiazides (diuretics or ‘water pills') 
• tiazide (diuretiki ali “zdravila za odvajanje vode”),
Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid) and is highly bound to plasma proteins in humans (greater than 
Porazdelitev Za farmakokinetiko repaglinida je značilen majhen volumen porazdelitve (30 l), kar je v skladu s porazdelitvijo v znotrajcelični tekočini, vezava na plazemske proteine pri človeku pa je obsežna (več kot 98 %).
• Severe liver problems, abnormal liver function such as increased liver enzymes in your blood. 
• hude težave z jetri, moteno delovanje jeter, zvišana koncentracija jetrnih encimov v krvi
In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4. 
Podatki in vitro raziskav kažejo, da se repaglinid presnavlja pretežno s CYP2C8, vendar pa tudi s CYP3A4.
• Beta blockers (used to treat high blood pressure or heart conditions) 
• zaviralce adrenergičnih receptorjev beta (uporabljamo jih za zdravljenje visokega krvnega tlaka ali bolezni srca),
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark 
DK-2880 Bagsvaerd Danska
• If you have a severe liver disease. 
• imate hudo bolezen jeter,
• Clopidogrel (prevents blood clots) 
• klopidogrel (zdravilo, ki preprečuje nastajanje krvnih strdkov),
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%). 
Za farmakokinetiko repaglinida je značilna 63 % povprečna absolutna biološka uporabnost
Abdominal pain, diarrhoea Common Vomiting, constipation Very rare Nausea 
Bolezni prebavil bolečina v trebuhu, driska pogosti bruhanje, zaprtost zelo redki navzea neznana
Hepatic impairment No clinical studies have been conducted in patients with hepatic insufficiency. 
Pri bolnikih z jetrno insuficienco klinične študije niso bile izvedene.
Each pack contains 30, 90, 120 or 270 tablets. 
30, 90, 120 ali 270 tablet.
Prandin is not recommended in patients with moderate liver disease. 
Uporaba zdravila Prandin pri bolnikih z zmerno boleznijo jeter ni priporočljiva.
• If you take too much Prandin 
• če ste vzeli prevelik odmerek zdravila Prandin,
How to store Prandin 
Shranjevanje zdravila Prandin
• Deferasirox (used to reduce chronic iron overload) 
• deferasiroks (uporabljamo ga za zdravljenje kronične preobremenitve z železom),
Polacrilin potassium Povidone (polyvidone) Glycerol 85% 
glicerol, 85-odstotni magnezijev stearat meglumin poloksamer
The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids. 
gemfibrozil, klaritromicin, itrakonazol, ketokonazol, trimetoprim, ciklosporin, deferasiroks, klopidogrel, drugi antidiabetiki, zaviralci monoaminooksidaze (zaviralci MAO), neselektivni antagonisti adrenergičnih receptorjev beta, zaviralci angiotenzinske konvertaze (zaviralci ACE),
Prandin 0.5 mg tablets Prandin 1 mg tablets Prandin 2 mg tablets 
Navodilo za uporabo Prandin 0,5 mg tablete Prandin 1 mg tablete Prandin 2 mg tablete repaglinid
Prandin should not be taken if you have a severe liver disease (see Do not take Prandin). 
Bolniki s hudo boleznijo jeter zdravila Prandin ne smejo jemati (glejte podpoglavje Ne jemljite zdravila Prandin);
Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided. 
Ker profil varnosti te kombinacije zdravil pri odmerkih, višjih od 0,25 mg za repaglinid in 320 mg za trimetoprim še ni bil ugotovljen, se je treba sočasni uporabi trimetoprima in repaglinida izogibati.
• Severe hepatic function disorder. 
• Hudo moteno delovanje jeter.
• Thyroid products (used to treat low levels of thyroid hormones) 
• zdravila za ščitnico (uporabljamo jih za zdravljenje nizke ravni ščitničnih hormonov),
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present. 
tako ob uvedbi zdravljenja z rifampicinom (akutna inhibicija), kot ob nadaljevanju (mešana inhibicija in indukcija) ter ukinitvi zdravljenja (samo indukcija) in še približno do dva tedna po ukinitvi rifampicina, ko indukcijski učinek rifampicina izzveni.
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the active substance. 
Absorpcija Repaglinid se hitro absorbira iz prebavil, zato se koncentracija zdravilne učinkovine v plazmi hitro zveča.
Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4 can be increased if CYP2C8 is inhibited. 
Klinični podatki, pridobljeni pri zdravih prostovoljcih, potrjujejo domnevo, da je CYP2C8 najpomembnejši encim pri presnovi repaglinida in da ima CYP3A4 pri tem le manjšo vlogo, vendar pa se relativni prispevek CYP3A4 v primeru zavrtja CYP2C8 lahko poveča.
Do not take Prandin 
Prandin ne smete jemati.
Warnings and precautions Talk to your doctor before taking Prandin: 
Pred začetkom jemanja zdravila Prandin se posvetujte s svojim zdravnikom:
Abnormal hepatic function, increased liver enzymes* 
Moteno delovanje jeter, zvišana vrednost jetrnih encimov
Embryotoxicity, abnormal limb development in rat foetuses and new born pups, was observed in female rats exposed to high doses in the last stage of pregnancy and during the lactation period. 
katerih matere so bile v zadnjem obdobju brejosti in med laktacijo izpostavljene visokim odmerkom repaglinida, so opazili embriotoksične učinke in nenormalen razvoj okončin.
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed. 
Kombinacija z insulinom NPH (Neutral Protamine Hagedorn) ali s tiazolidindioni Preskušanja s kombiniranim zdravljenjem z insulinom NPH ali s tiazolidindioni so bila izvedena, vendar pa je treba profil koristi in tveganj v primerjavi z drugimi kombiniranimi zdravljenji še ugotoviti.
The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ml x hr (28.3) in healthy volunteers, 304.9 ng/ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ml x hr (83.8) in the elderly type 2 diabetic patients. 
Po posamičnem odmerku 2 mg (4 mg pri bolnikih z insuficienco jeter) je vrednost AUC (SD) pri zdravih prostovoljcih znašala 31,4 ng/ml x ura (28,3), pri bolnikih z insuficienco jeter 304,9 ng/ml x ura (228,0), pri starostnikih s sladkorno boleznijo tipa 2 pa 117,9 ng/ml x ura (83,8).
Your ability to drive or use a machine may be affected if your blood sugar is low or high. 
Previsok ali prenizek krvni sladkor lahko vpliva na sposobnost upravljanja vozil in strojev.
Very rare (may affect up to 1 in 10,000 patients) 
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide. 
Pri bolnikih s sladkorno boleznijo tipa 2 so pri uporabi repaglinida v odmerkih od 0,5 do 4 mg dokazali od odmerka odvisno znižanje glukoze v krvi.
• Monoamine oxidase inhibitors (MAOI) (used to treat depression) 
• zaviralce monoaminooksidaz (zaviralci MAO, uporabljamo jih za zdravljenje depresije),
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces. 
da bi uravnal koncentracijo sladkorja v krvi ali pa se telo ne odziva normalno na insulin, ki ga proizvaja.
Plasma repaglinide levels decreased rapidly, and low concentrations were seen in the plasma of type 2 diabetic patients 4 hours post-administration. 
Nizko koncentracijo so v plazmi bolnikov s sladkorno boleznijo tipa 2 ugotovili 4 ure po uporabi.
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed. 
Če je sočasna uporaba obeh zdravil nujna, je treba pazljivo nadzirati vrednosti glukoze v krvi in bolnika natančno klinično spremljati.
MARKETING AUTHORISATION NUMBERS 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide. 
nifedipin, estrogen ali simvastatin, se farmakokinetične lastnosti repaglinida niso pomembneje spremenile.
Common (may affect up to 1 in 10 patients) 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
The resulting increased calcium influx induces insulin secretion from the β-cell. 
Vtok kalcija se zato zveča in to sproži izločanje insulina iz celic β.
Abnormal hepatic function, increased liver enzymes Isolated cases of increased liver enzymes have been reported during treatment with repaglinide. 
Med zdravljenjem z repaglinidom so poročali o posameznih primerih zvišanja vrednosti jetrnih encimov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of repaglinide. 
Ena tableta vsebuje 0,5 mg repaglinida.
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines) 
• simpatikomimetike (uporabljamo jih za zdravljenje astme), • klaritromicin, trimetoprim, rifampicin (antibiotiki),
They include: increased urination; feeling thirsty; dry skin and dry mouth. 
Opozorilni znaki previsokega krvnega sladkorja se pojavijo postopoma in vključujejo: pogostejše uriniranje, občutek žeje, suho kožo in suha usta.
Prandin should be taken with caution. 
V tem primeru morate zdravilo Prandin uporabljati previdno;
• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood). 
• jemljete gemfibrozil (zdravilo za zdravljenje zvišane koncentracije maščob v krvi).
- The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets. 
- Pomožne snovi so: mikrokristalna celuloza (E460), brezvodni kalcijev hidrogenfosfat, koruzni škrob, polakrilin kalij, povidon (polividon), 85-odstotni glicerol, magnezijev stearat, meglumin,
Less than 1% of repaglinide is recovered in faeces. 
Z blatom se izloči manj kot 1 %
It has not been studied in these age groups. 
Uporaba zdravila Prandin ni priporočljiva, saj njegova uporaba v teh starostnih skupinah ni bila raziskana.
Special care should be taken when inhibitors of both CYP2C8 and 3A4 are co-administered simultaneously with repaglinide. 
Posebna previdnost je potrebna v primeru sočasne uporabe repaglinida in zdravil, ki zavirajo tako CYP2C8 kot 3A4.
If your blood sugar gets too high 
V primeru prekomernega zvišanja koncentracije krvnega sladkorja
• If you have an infection or a fever 
• če imate okužbo ali zvišano telesno temperaturo, • če jeste več kot ponavadi,
• Gemfibrozil (used to treat high blood fats) 
• gemfibrozil (zdravilo za zdravljenje zvišane koncentracije maščob v krvi),
You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low. 
V primeru pojava hipe (nizka koncentracija krvnega sladkorja) Če se vam krvni sladkor prekomerno zniža, lahko doživite hipo (hipa je okrajšava za hipoglikemijo in pomeni simptome nizkega krvnega sladkorja).
Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels. 
Pri sočasni uporabi trimetoprima (v odmerku 160 mg dvakrat na dan), srednje močnega zaviralca CYP2C8, in repaglinida (v enkratnem odmerku 0,25 mg), se je vrednost AUC repaglinida povečala za 1,6-krat, vrednost Cmax za 1,4-krat, vrednost t½ pa za 1,2-krat, brez statistično pomembnega vpliva na vrednosti glukoze v krvi.
MARKETING AUTHORISATION NUMBERS EU/1/00/162/009-11, EU/1/00/162/020 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/162/009-011, EU/1/00/162/020
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers. 
Pri sočasni uporabi gemfibrozila (v odmerku 600 mg dvakrat na dan), zaviralca CYP2C8, in repaglinida (v enkratnem odmerku 0,25 mg), se je pri zdravih prostovoljcih vrednost AUC repaglinida povečala za 8,1-krat, vrednost Cmax pa za 2,4-krat.
EU/1/00/162/009 30 tablets EU/1/00/162/010 90 tablets EU/1/00/162/011 120 tablets EU/1/00/162/020 270 tablets 
EU/1/00/162/009 30 tablet EU/1/00/162/010 90 tablet EU/1/00/162/011 120 tablet EU/1/00/162/020 270 tablet
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Prandin. 
Če jemljete gemfibrozil (zdravilo za zdravljenje zvišane koncentracije maščob v krvi), zdravila
What Prandin contains 
Eno pakiranje vsebuje
EU/1/00/162/015 30 tablets EU/1/00/162/016 90 tablets EU/1/00/162/017 120 tablets EU/1/00/162/019 270 tablets 
EU/1/00/162/015 30 tablet EU/1/00/162/016 90 tablet EU/1/00/162/017 120 tablet EU/1/00/162/019 270 tablet
EU/1/00/162/003 30 tablets EU/1/00/162/004 90 tablets EU/1/00/162/005 120 tablets EU/1/00/162/021 270 tablets 
EU/1/00/162/003 30 tablet EU/1/00/162/004 90 tablet EU/1/00/162/005 120 tablet EU/1/00/162/021 270 tablet
MARKETING AUTHORISATION NUMBERS EU/1/00/162/003-005, EU/1/00/162/021 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/162/003-005, EU/1/00/162/021
MARKETING AUTHORISATION NUMBERS EU/1/00/162/015-17, EU/1/00/162/019 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/162/015-017, EU/1/00/162/019
At such times diabetic control may be lost. 
V takšnih primerih lahko sladkorna bolezen postane neurejena;
In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively. 
V študiji pri zdravih prostovoljcih se je pri sočasni uporabi repaglinida (enkratni 0,25-mg odmerek) in ciklosporina (ponavljajoči se 100-mg odmerki) vrednost AUC repaglinida povečala za približno 2,5
• Visual disturbances 
• motnje vida
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of repaglinide. 
Ena tableta vsebuje 2 mg repaglinida.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide. 
Ena tableta vsebuje 1 mg repaglinida.
Consequently metabolism, and by that clearance of repaglinide, may be altered by substances which influence these cytochrome P-450 enzymes via inhibition or induction. 
V primeru uporabe učinkovin, ki vplivajo na ta encima citokroma P-450, bodisi z inhibicijo bodisi indukcijo, se presnova in s tem tudi očistek repaglinida lahko spremeni.
Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets. 
Koncentracijo glukoze v krvi hitro zmanjša tako, da stimulira sproščanje insulina iz trebušne slinavke.
• Feeling sick (nausea). 
• siljenje na bruhanje (navzea)
Name and address of the manufacturer responsible for batch release 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Novo Nordisk A/S
Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull). 
Tablete repaglinida so bele, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik Apis).
After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min. 
Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina: 20-39 ml/min) so rezultati po 5dnevnem zdravljenju z repaglinidom (2 mg 3-krat na dan) pokazali pomembno 2-kratno zvečanje izpostavljenosti (AUC) in razpolovnega časa (t1/2) v primerjavi z bolniki z normalnim delovanjem ledvic.
Hypoglycaemic coma and hypoglycaemic unconsciousness 
Presnovne in prehranske motnje hipoglikemija pogosti hipoglikemična koma in hipoglikemična nezavest neznana
You should not take Prandin if you are breast-feeding. 
Če dojite, zdravila Prandin ne smete jemati.
Be aware that the desired effect is not achieved if you stop taking Prandin. 
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.
Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull). 
Tablete repaglinida so breskove barve, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik Apis).
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch 
brezvodni kalcijev hidrogenfosfat koruzni škrob polakrilin kalij povidon (polividon)
In an interaction study in healthy volunteers, coadministration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold. 
V študiji medsebojnega delovanja z drugimi zdravili, izvedeni pri zdravih prostovoljcih, se je pri sočasni uporabi klaritromicina v odmerku 250 mg, ki močno zavira encimski mehanizem CYP3A4, vrednost AUC repaglinida zvečala za 1,4-krat, vrednost Cmax pa za 1,7-krat.
What you need to know before you take Prandin 
Kaj morate vedeti, preden boste vzeli zdravilo Prandin Ne jemljite zdravila Prandin, če:
Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull). 
Tablete repaglinida so rumene, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik
Always take this medicine exactly as your doctor has told you. 
Kako jemati zdravilo Prandin Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika.
Iron oxide, yellow (E172) 
poloksamer, rumeni železov oksid (E172) v 1-mg tabletah in rdeči železov oksid (E172) v 2-mg tabletah.
- The active substance is repaglinide. 
Repaglinid se skoraj v celoti presnovi.
• If you take too little Prandin 
To se lahko zgodi: • če ste vzeli premajhen odmerek zdravila Prandin,
• ACE-inhibitors (used to treat heart conditions) 
• zaviralce angiotenzinske konvertaze (zaviralci ACE, uporabljamo jih za zdravljenje bolezni srca),
Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment. 
Pri bolnikih z okvaro ledvic je celoten plazemski očistek zdravila manjši.
A number of medicinal products are known to influence repaglinide metabolism. 
Kaj vsebuje zdravilo Prandin - Zdravilna učinkovina je repaglinid.
Concomitant use 
za peroralno uporabo
GROUNDS FOR NEGATIVE OPINION 
RAZLOGI ZA NEGATIVNO MNENJE
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NEGATIVE OPINION 
DODATEK II ZNANSTVENI ZAKLJUČKI IN RAZLOGI ZA NEGATIVNO MNENJE
08013-Barcelona Spain 
08013-Barcelona Španija
For parametric analysis, the 90% confidence interval was calculated. 
Za parametrično analizo so izračunali 90 % interval zaupanja.
In order to consider the parent compound as inactive, a significantly lower level of activity would have been required. 
Da bi matično spojino uvrstili med neaktivne, bi bila potrebna pomembno nižja raven aktivnosti.
Histamine is a major mediator of the allergic reaction. 
Histamin je pomemben posrednik v alergijski reakciji.
A post hoc justification for widening the acceptance range as was done for study SZ190/08 can therefore not be accepted. 
Post hoc utemeljitev za razširitev razpona sprejemljivosti, kot je bila narejena pri študiji SZ190/08, zato ne more biti sprejeta.
This situation should have been foreseen and included in the study protocol and the CHMP therefore considers this to constitute a major objection. 
Ta situacija bi morala biti predvidena in vključena v protokol študije, zato je CHMP mnenja, da predstavlja to pomemben ugovor.
80 subjects were enrolled in the study and randomly assigned to a treatment. 
V študijo je bilo vključenih 80 oseb in ti so bili naključno razporejeni v zdravljenje.
The Applicant requested an oral explanation in front of the committee in order to discuss the outcome of the CHMP assessment. 
Predlagatelj je zaprosil za ustna pojasnila pred odborom, da bi se posvetovali o izidu ocene CHMP.
This increase justifies either an additional increase of subjects included in the study or a widening of the acceptance criteria. 
To povečanje utemeljuje dodatno povečano število oseb, vključenih v študijo, ali razširitev kriterijev sprejemljivosti.
ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSIONS 
DODATEK III POGOJI ZA PREKLIC UMIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Verovskova 57 SI-1000 Ljubljana Slovenia 
Verovškova 57 SI-1000 Ljubljana Slovenija
No clinically significant abnormalities were observed and the results confirmed the absence of significant changes in the subjects' state of health. 
Klinično pomembnih nepravilnosti niso opazili, rezultati pa so potrdili odsotnost pomembnih sprememb v zdravstvenem stanju oseb.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder(s): 
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, zagotovijo, da imetnik(-i) dovoljenja za promet z zdravilom izpolnjujejo sledeče pogoje:
A total of 30 post-dose adverse events were reported, with 6 adverse events probably related to the study treatment, 11 possibly related, 2 remotely related, and 11 unrelated. 
Poročali so o skupno 30 neželenih učinkih, opaženih po zaužitju odmerka, od česar je bilo verjetno 6 neželenih učinkov povezanih z obdelavo študije, 11 morda povezanih, 2 šibko povezana in 11 nepovezanih.
The Applicant assumption that the parent compound is inactive was not accepted, as the absolute activity should be taken into account, rather than the ratio of activity compared to the metabolite. 
Predlagateljeva domneva, da matična spojina ni aktivna, ni bila sprejeta, saj je treba upoštevati absolutno aktivnost in ne delež aktivnosti v primerjavi z metabolitom.
It was concluded that any arguments for the widening of the acceptance range must be discussed prospectively, and reflected in the protocol. 
Zaključili so, da je treba o vseh vprašanjih glede širjenja razpona sprejemljivosti razpravljati vnaprej, in to se mora odražati tudi v protokolu.