natgillin/translations-raw huggingface dataset:
Capsule shell Hypromellose Carrageenan (E407) Potassium chloride Titanium dioxide (E171) Carnauba wax Purified water 
Ovoj kapsul hipromeloza karagenan (E407) kalijev klorid titanov dioksid (E171) karnauba vosek prečiščena voda
28 days, followed by a cross-over to the alternate treatment for a second 28 day period. 
V prvem obdobju zdravljenja so bolniki 28 dni prejemali zdravilo Enzepi ali primerjalno zdravilo, nato so prešli na nadomestno zdravilo za dodatno 28-dnevno obdobje.
Enzepi is supplied in plastic (HDPE) bottles with desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner. 
Zdravilo Enzepi je na voljo v plastenkah (HDPE), ki vsebujejo vrečice s sušilom, zaprtih z obloženo polipropilensko za otroke varno zaporko in odstranljivo tesnilno oblogo.
HDPE bottle containing desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner. 
Plastenka iz HDPE z vrečicami sušilnega sredstva, zaprta z obloženo polipropilensko za otroke varno zaporko in odstranljivo tesnilno oblogo.
25,000 units*, 
25.000 enot*,
Additionally for Enzepi 10,000 units gastro-resistant granules Yellow iron oxide (E172) 
Dodatno pri zdravilu Enzepi 10.000 enot gastrorezistentna zrnca rumeni železov oksid (E172)
40,000 units*, 
40.000 enot*,
EUR 1009-M was an open-label, single arm study in 19 patients, ages 1 to 6 years, with EPI due to CF. 
Študija EUR-1009-M je bila odprta študija z eno skupino pri 19 bolnikih, starih od 1 do 6 let, s pomanjkljivim eksokrinim delovanjem trebušne slinavke zaradi cistične fibroze.
Enzepi 5,000 units gastro-resistant hard capsules Enzepi 10,000 units gastro-resistant hard capsules Enzepi 25,000 units gastro-resistant hard capsules Enzepi 40,000 units gastro-resistant hard capsules 
Enzepi 5.000 enot gastrorezistentne trde kapsule Enzepi 10.000 enot gastrorezistentne trde kapsule Enzepi 25.000 enot gastrorezistentne trde kapsule Enzepi 40.000 enot gastrorezistentne trde kapsule
- amylolytic activity: 
- amilolitična aktivnost:
However as pancreatic enzymes are not absorbed from the gastrointestinal tract, no systemic toxicity is expected following oral administration of pancreas powder. 
Vendar po peroralnem jemanju uprašenega pankreasa ni pričakovati sistemske toksičnosti, ker se encimi trebušne slinavke ne absorbirajo iz prebavil.
Potential for irritation to oral mucosa 
Možnost draženja ustne sluznice
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains: lipase: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje: lipaza:
Data generated in the CF population with EPI can be extrapolated to the other causes of EPI such as chronic pancreatitis, post pancreatectomy or pancreatic cancer. 
Podatki, pridobljeni pri populaciji s cistično fibrozo s pomanjkljivim eksokrinim delovanjem trebušne slinavke, se lahko upoštevajo tudi pri pomanjkljivem eksokrinem delovanju trebušne slinavke zaradi drugih vzrokov, kot so kronični pankreatitis, odstranitev trebušne slinavke ali rak trebušne slinavke.
not less than 130 units* 
130 enot*.
Hyperuricaemia/ hyperuricosuria** Decreased appetite 
Presnovne in prehranske motnje hiperurikemija/hiperurikozurija**, zmanjšan tek
5,000 units*, 
5.000 enot*,
not less than 270 Ph. Eur. 
270 enot po Ph. Eur..
40,000 Ph. Eur. 
40.000 enot po Ph.
Paediatric population between 1 and less than 4 years of age For children between 1 and less than 4 years of age the recommended starting dose is 1,000 lipase units/kg of body weight per meal. 
Pri otrocih, starih od 1 do manj kot 4 let, je priporočeni začetni odmerek 1.000 enot lipaze/kg telesne mase na obrok.
10,000 units*, 
10.000 enot*,
25,000 Ph. Eur. 
25.000 enot po Ph.
Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder). 
Pri uporabi zdravil z encimi trebušne slinavke v različnih formulacijah iste učinkovine (uprašenega pankreasa) so redko poročali o anafilaktičnih reakcijah.
units amylolytic activity: 
amilolitična aktivnost:
not less than 3,200 units* 
3.200 enot*,
lipolytic activity: 
lipolitična aktivnost:
It is only in the duodenum, which has a different environment with a pH value greater than 5, that these digestive enzymes are released from the granules. 
Ti prebavni encimi se sprostijo iz granul šele v dvanajstniku, ki ima drugačno okolje in vrednost pH, višjo od 5.
units proteolytic activity: 
proteolitična aktivnost:
Do not chew the capsules. 
Kapsule je treba pogoltniti cele.
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. 
Pri bolnikih s cistično fibrozo, ki so jemali velike odmerke zdravil s pankreatinom, so poročali o strikturah ileocekalnega predela in debelega črevesa (fibrozirajoča kolonopatija).
Do not eat or open the desiccant sachets. 
Vrečic s sušilom ne smete pojesti ali odpreti.
INFORMATION IN BRAILLE Enzepi 25,000 
PODATKI V BRAILLOVI PISAVI Enzepi 25.000
INFORMATION IN BRAILLE Enzepi 40,000 
PODATKI V BRAILLOVI PISAVI Enzepi 40.000
not less than 650 units* 
650 enot*.
INFORMATION IN BRAILLE Enzepi 5,000 
PODATKI V BRAILLOVI PISAVI Enzepi 5.000
Dispose of any accidentally crushed capsule. 
Kapsule, ki so se po nesreči zdrobile, zavrzite.
not less than 3,200 Ph. Eur. 
3.200 enot po Ph.
not less than 7,800 units* 
7.800 enot*,
Care should be taken to ensure that Enzepi is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa. 
Zaradi preprečitve draženja ustne sluznice je treba paziti, da se zdravilo Enzepi ne zdrobi ali žveči ali zadržuje v ustih.
Constipation Abdominal distension Flatulence 
eritematozni izpuščaj, pruritus
not less than 7,800 Ph. Eur. 
7.800 enot po Ph.
Additionally for Enzepi 25,000 units gastro-resistant granules Yellow iron oxide (E172) 
Dodatno pri zdravilu Enzepi 25.000 enot gastrorezistentna zrnca rumeni železov oksid (E172) indigotin (E132)
Enzepi 25,000 units gastro-resistant hard capsules One capsule contains 209.3 mg of pancreas powder including the following enzymatic activites: - lipolytic activity: 
Enzepi 25.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 209,3 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
Enzepi 10,000 units gastro-resistant hard capsules One capsule contains 83.7 mg of pancreas powder including the following enzymatic activites: - lipolytic activity: 
Enzepi 10.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 83,7 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
not less than 4,800 Ph. Eur. 
4.800 enot po Ph.
After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container. 
Po prvem odprtju plastenke lahko zdravilo hranite največ 6 mesecev pri temperaturi do 25 °C v trdno zaprtem vsebniku.
One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: 
Ena kapsula vsebuje 83,7 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
Enzepi 5,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water. 
Enzepi 5000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda;
not less than 130 Ph. Eur. 
130 enot po Ph. Eur..
Enzepi capsules or the granules inside them should not be crushed or chewed and the capsules or the granules inside them should not be held in your or your child's mouth. 
Kapsule zdravila Enzepi ali zrnca iz njihove notranjosti se ne smejo drobiti ali žvečiti.
Keep the bottle tightly closed and the desiccant in the bottle in order to protect from moisture. 
Plastenko shranjujte tesno zaprto in ne odstranite sušilnega sredstva za zagotovitev zaščite pred vlago.
Enzepi 40,000 units gastro-resitant hard capsules One capsule contains 334.9 mg of pancreas powder including the following enzymatic activites: - lipolytic activity: 
Enzepi 40.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 334,9 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
Enzepi 10,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172). 
Enzepi 10.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, rumeni železov oksid (E172);
5,000 Ph. Eur. 
5.000 enot po Ph.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 25,000 unit strength 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 25.000 enot
One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: 
Ena kapsula vsebuje 209,3 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
not less than 4,800 units* 
4.800 enot*,
INFORMATION IN BRAILLE Enzepi 10,000 
PODATKI V BRAILLOVI PISAVI Enzepi 10.000
Enzepi 25,000 units gastro-resistant hard capsules 
Enzepi 25.000 enot gastrorezistentne trde kapsule
Capsules should be swallowed whole and not chewed or crushed. 
Ne smejo se žvečiti ali drobiti.
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije utrujenost, splošno slabo počutje
10,000 Ph. Eur. 
10.000 enot po Ph.
A rare bowel condition called ‘fibrosing colonopathy', where the intestine is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes. 
Pri bolnikih s cistično fibrozo, ki so prejemali velike odmerke encimov trebušne slinavke, so poročali o redki bolezni z zoženjem črevesa, ki se imenuje fibrozirajoča kolonopatija.
Enzepi 5,000 units gastro-resistant hard capsules One capsule contains 39.8 mg of pancreas powder including the following enzymatic activities: - lipolytic activity: 
Enzepi 5.000 enot gastrorezistentne trde kapsule Ena kapsula vsebuje 39,8 mg uprašenega pankreasa z naslednjimi stopnjami encimske aktivnosti: - lipolitična aktivnost:
not less than 1,600 Ph. Eur. 
1.600 enot po Ph.
One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: 
Ena kapsula vsebuje 334,9 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
not less than 650 Ph. Eur. 
650 enot po Ph. Eur..
The Enzepi 40,000 units gastro-resistant hard capsule has a blue opaque cap and a white opaque body with ‘Enzepi 40' printed on it and contains light-brown gastro-resistant granules. 
Gastrorezistentna trda kapsula Enzepi 40.000 enot ima modro neprosojno kapico in belo neprosojno telo z natisom »Enzepi 40« ter vsebuje svetlo rjava gastrorezistentna zrnca.
The Enzepi 25,000 units gastro-resistant hard capsule has a green opaque cap and a white opaque body with ‘Enzepi 25' printed on it and contains light-brown gastro-resistant granules. 
Gastrorezistentna trda kapsula Enzepi 25.000 enot ima zeleno neprosojno kapico in belo neprosojno telo z natisom »Enzepi 25« ter vsebuje svetlo rjava gastrorezistentna zrnca.
Hard capsule with a blue opaque cap and a white opaque body, printed with “Enzepi 40” and containing light-brown gastro-resistant granules. 
Trda kapsula z modro neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 40«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
Enzepi 40,000 units gastro-resistant hard capsules 
Enzepi 40.000 enot gastrorezistentne trde kapsule
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 40,000 unit strength 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 40.000 enot
Enzepi 10,000 units gastro-resistant hard capsules 
Enzepi 10.000 enot gastrorezistentne trde kapsule
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 5,000 unit strength 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 5.000 enot
The Enzepi 5,000 units gastro-resistant hard capsule has a white opaque cap and a white opaque body with ‘Enzepi 5' printed on it and contains light-brown gastro-resistant granules. 
Gastrorezistentna trda kapsula Enzepi 5.000 enot ima belo neprosojno kapico in belo neprosojno telo z natisom »Enzepi 5« ter vsebuje svetlo rjava gastrorezistentna zrnca.
not less than 410 Ph. Eur. 
410 enot po Ph. Eur..
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 83,7 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: 
Ena kapsula vsebuje 39,8 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
Hard capsule with a green opaque cap and a white opaque body, printed with “Enzepi 25” and containing light-brown gastro-resistant granules. 
Trda kapsula z zeleno neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 25«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
The Enzepi 10,000 units gastro-resistant hard capsule has a yellow opaque cap and a white opaque body with ‘Enzepi 10' printed on it and contains light-brown gastro-resistant granules. 
Gastrorezistentna trda kapsula Enzepi 10.000 enot ima rumeno neprosojno kapico in belo neprosojno telo z natisom »Enzepi 10« ter vsebuje svetlo rjava gastrorezistentna zrnca.
not less than 410 units* 
410 enot*.
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 209,3 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
NAME OF THE MEDICINAL PRODUCT Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder 
Enzepi 25.000 enot gastrorezistentne trde kapsule uprašeni pankreas
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 334,9 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
Hard capsule with a yellow opaque cap and a white opaque body, printed with “Enzepi 10” and containing light-brown gastro-resistant granules. 
Trda kapsula z rumeno neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 10«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
Hard capsules with a white opaque cap and a white opaque body, printed with “Enzepi 5” and containing light-brown gastro-resistant granules. 
Trda kapsula z belo neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 5«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10,000 unit strength 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 10.000 enot
Enzepi 5,000 units gastro-resistant hard capsules 
Enzepi 5.000 enot gastrorezistentne trde kapsule
units amylase: 
amilaza:
EU/1/16/1113/013 20 gastro-resistant hard capsules EU/1/16/1113/014 50 gastro-resistant hard capsules EU/1/16/1113/015 100 gastro-resistant hard capsules EU/1/16/1113/016 200 gastro-resistant hard capsules 
EU/1/16/1113/013 20 gastrorezistentnih trdih kapsul EU/1/16/1113/014 50 gastrorezistentnih trdih kapsul EU/1/16/1113/015 100 gastrorezistentnih trdih kapsul EU/1/16/1113/016 200 gastrorezistentnih trdih kapsul
EU/1/16/1113/005 20 gastro-resistant hard capsules EU/1/16/1113/006 50 gastro-resistant hard capsules EU/1/16/1113/007 100 gastro-resistant hard capsules EU/1/16/1113/008 200 gastro-resistant hard capsules 
EU/1/16/1113/005 20 gastrorezistentnih trdih kapsul EU/1/16/1113/006 50 gastrorezistentnih trdih kapsul EU/1/16/1113/007 100 gastrorezistentnih trdih kapsul EU/1/16/1113/008 200 gastrorezistentnih trdih kapsul
Enzepi 25,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172), indigotine E132. 
Enzepi 25.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, rumeni železov oksid (E172), indigotin (E132); Enzepi 40.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, indigotin (E132); o tiskarsko črnilo: šelak, propilenglikol, indigotin (E132).
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 39,8 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
PARTICULARS TO APPEAR ON THE INNER PACKAGING BOTTLE LABEL - 5,000 unit strength 
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI - Jakost 5.000 enot
NAME OF THE MEDICINAL PRODUCT Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder 
Enzepi 40.000 enot gastrorezistentne trde kapsule uprašeni pankreas
NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder 
Enzepi 5.000 enot gastrorezistentne trde kapsule uprašeni pankreas
not less than 1,600 units* 
1.600 enot*,
EU/1/16/1113/009 20 gastro-resistant hard capsules EU/1/16/1113/010 50 gastro-resistant hard capsules EU/1/16/1113/011 100 gastro-resistant hard capsules EU/1/16/1113/012 200 gastro-resistant hard capsules 
EU/1/16/1113/009 20 gastrorezistentnih trdih kapsul EU/1/16/1113/010 50 gastrorezistentnih trdih kapsul EU/1/16/1113/011 100 gastrorezistentnih trdih kapsul EU/1/16/1113/012 200 gastrorezistentnih trdih kapsul
NAME OF THE MEDICINAL PRODUCT Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder 
Enzepi 10.000 enot gastrorezistentne trde kapsule uprašeni pankreas
EU/1/16/1113/001 20 gastro-resistant hard capsules EU/1/16/1113/002 50 gastro-resistant hard capsules EU/1/16/1113/003 100 gastro-resistant hard capsules EU/1/16/1113/004 200 gastro-resistant hard capsules 
EU/1/16/1113/001 20 gastrorezistentnih trdih kapsul EU/1/16/1113/002 50 gastrorezistentnih trdih kapsul EU/1/16/1113/003 100 gastrorezistentnih trdih kapsul EU/1/16/1113/004 200 gastrorezistentnih trdih kapsul
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 10,000 unit strength 
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI - Jakost 10.000 enot
1 Following the outcome of an Article 31 referral procedure on tolperisone-containing medicinal products, for which a Commission decision was adopted in January 2013. 
1 V skladu z izidom napotitvenega postopka v skladu s členom 31 za zdravila, ki vsebujejo tolperizon, za katerega je bil sklep Komisije sprejet januarja 2013.
• The Committee considered the notification of the referral triggered by Hungary under Article 29(4) of Directive 2001/83/EC where Germany raised objections that were considered to be a potential serious risk to public health; 
• odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Madžarska skladno s členom 29(4) Direktive 2001/83/ES in v katerem je Nemčija izrazila pomisleke, ki bi lahko bili povezani z resnim tveganjem za javno zdravje;
The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure. 
Skupina CMDh je zato zadevo napotila na odbor CHMP na podlagi napotitvenega postopka iz člena 29(4).
During the CMDh2 referral procedure that followed the mutual recognition procedure (MRP), no consensus could be reached as the objecting member state maintained its objection, which was thought to represent a potential serious risk to public health. 
Med napotitvenim postopkom skupine CMDh2, ki je sledil postopku z medsebojnim priznavanjem, ni bilo mogoče doseči soglasja, saj je omenjena država članica vztrajala pri pomisleku, ki bi lahko bil povezan z resnim tveganjem za javno zdravje.
The marketing authorisation application (MAA) for Merisone was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc). 
Vloga za pridobitev dovoljenja za promet z zdravilom Merisone je bila predložena v skladu s členom 10(1) Direktive 2001/83/ES (tj. generična vloga) in je temeljila na referenčnem zdravilu Mydeton (Gedeon Richter Plc).
• The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Merisone with respect to the reference medicinal product; 
• odbor je pregledal odgovore, ki jih je predložil predlagatelj, da bi razrešil odprta vprašanja v zvezi z biološko enakovrednostjo zdravila Merisone in referenčnega zdravila;
Therefore it was considered that fasting bioequivalence studies are expected to be more sensitive to detect formulation differences. 
Zato so ocenili, da je mogoče pričakovati, da so bioekvivalenčne študije v pogojih na tešče bolj občutljive za zaznavanje razlik med formulacijami.
Since the effect of these excipients would be diluted in the presence of food, it was considered unlikely that excipients such as mannitol would be larger in fed conditions compared to fasting conditions, given that the effect of mannitol is based on its osmotic effect. 
Ker bi se učinek teh pomožnih snovi ob prisotnosti hrane zmanjšal, so menili, da ni verjetno, da bi bil vpliv pomožnih snovi, kot je manitol, v pogojih na poln želodec večji kot v pogojih na tešče, saj učinek manitola temelji na osmotskem učinku.
Bioequivalence was demonstrated with regard to the primary pharmacokinetic parameters, i.e. AUC and Cmax, in the study with the 150 mg tablet, as the 90% CIs were within the required 80-125% limits. 
Biološko enakovrednost so dokazali pri primarnih farmakokinetičnih parametrih, tj. AUC in Cmaks, v študiji s 150-miligramsko tableto, kjer je bil 90-odstotni IZ znotraj zahtevanih mejnih vrednosti 80-125 %.
The active substance of Merisone is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults. 
Zdravilna učinkovina v zdravilu Merisone je tolperizonijev klorid, mišični relaksant, ki deluje na osrednje živčevje in je indiciran za simptomatsko zdravljenje spastičnosti, ki je posledica možganske kapi, pri odraslih.
The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Merisone and associated names (see Annex I). 
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot zadnje različice, dogovorjene med postopkom Usklajevalne skupine, za zdravilo Merisone in povezana imena (glejte Prilogo I).
Furthermore it was argued that serious concerns remained as to whether the test product in this case (that is advised to be taken concomitantly with food), would be bioequivalent under fed conditions, given that the results of the bioequivalence studies under fasted conditions were borderline. 
Poleg tega je trdila, da še vedno obstajajo resni pomisleki glede tega, ali bi v tem primeru preiskovano zdravilo (za katerega se priporoča jemanje skupaj s hrano) bilo biološko enakovredno v pogojih na poln želodec, saj so bili rezultati bioekvivalenčnih študij v pogojih na tešče na meji.
The applicant highlighted that, at the time the bioequivalence studies were performed, the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention that the food effect was significant. 
Predlagatelj je poudaril, da v času izvajanja bioekvivalenčnih študij povzetek glavnih značilnosti zdravila za referenčno zdravilo ni vseboval nobenih priporočil v zvezi s hrano niti navedbe o tem, da je vpliv hrane pomemben.