natgillin/translations-raw huggingface dataset:
EU/1/16/1113/005 20 enterokapsler, hårde EU/1/16/1113/006 50 enterokapsler, hårde EU/1/16/1113/007 100 enterokapsler, hårde EU/1/16/1113/008 200 enterokapsler, hårde 
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/1/16/1113/013 20 enterokapsler, hårde EU/1/16/1113/014 50 enterokapsler, hårde EU/1/16/1113/015 100 enterokapsler, hårde EU/1/16/1113/016 200 enterokapsler, hårde 
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
Enzepi 10.000 enheder, enterokapsler, hårde 
Enzepi 10,000 units gastro-resistant hard capsules
Enzepi 10.000 enheder, enterokapsler, hårde En kapsel indeholder 83,7 mg pancreas-pulver af porcin oprindelse, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Dosering 
Diarrhoea
LÆGEMIDLETS NAVN Enzepi 5.000 enheder, enterokapsler, hårde Pancreas-pulver 
NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder
EU/1/16/1113/009 20 enterokapsler, hårde EU/1/16/1113/010 50 enterokapsler, hårde EU/1/16/1113/011 100 enterokapsler, hårde EU/1/16/1113/012 200 enterokapsler, hårde 
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
LÆGEMIDLETS NAVN Enzepi 10.000 enheder, enterokapsler, hårde Pancreas-pulver 
NAME OF THE MEDICINAL PRODUCT Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder
EU/1/16/1113/001 20 enterokapsler, hårde EU/1/16/1113/002 50 enterokapsler, hårde EU/1/16/1113/003 100 enterokapsler, hårde EU/1/16/1113/004 200 enterokapsler, hårde 
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
Efter anbrud kan produktet opbevares i 6 måneder ved temperaturer under 25°C i den tæt tillukkede beholder. 
After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.
Efter åbning kan medicinen opbevares i højst 6 måneder ved temperaturer under 25°C med beholderen tæt tillukket for at beskytte mod fugt. 
After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container.
Hver kapsel indeholder 83,7 mg pancreas-pulver udvundet fra svin, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities:
Hver kapsel indeholder 209,3 mg pancreas-pulver udvundet fra svin, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities:
Enzepi 40.000 enheder, enterokapsler, hårde En kapsel indeholder 334,9 mg pancreas-pulver af porcin oprindelse, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Hver kapsel indeholder 39,8 mg pancreas-pulver udvundet fra svin, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities:
Hver kapsel indeholder 334,9 mg pancreas-pulver udvundet fra svin, med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities:
Enzepi 5.000 enheder, enterokapsler, hårde En kapsel indeholder 39,8 mg pancreas-pulver af porcin oprindelse med følgende enzymatiske aktivitet: lipaseaktivitet: amylaseaktivitet: proteaseaktivitet: 
STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
2 Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker 
2 Co-ordination group for mutual recognition and decentralised procedures - human
1 I henhold til resultatet af en artikel i 31-indbringelsesprocedure for lægemidler indeholdende tolperison, for hvilke der blev vedtaget en kommissionsbeslutning i januar 2013. 
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.
• Udvalget behandlede den indbringelse, der var indledt af Ungarn i henhold til artikel 29, stk. 4, i direktiv 2000/83/EF, under hvilken Tyskland rejste indvendinger, som blev anset for at være en potentiel alvorlig risiko for den offentlige sundhed, 
• 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;
Ved den indbringelsesprocedure for CMDh2, der efterfulgte den gensidige anerkendelsesprocedure, var det ikke muligt at nå til enighed, da den indsigende medlemsstat fastholdt sin indsigelse, som blev anset for at udgøre en potentiel alvorlig risiko for den offentlige sundhed. 
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.
CMDh indbragte derfor sagen for CHMP ved en artikel 29, stk. 4-indbringelsesprocedure. 
The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Det aktive stof i Merisone er tolperisonhydrochlorid, som er et muskelafslappende middel, der er indiceret til symptomatisk behandling af postapoplektisk spasticitet hos voksne. 
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.
• udvalget gennemgik ansøgerens besvarelse af de rejste spørgsmål om bioækvivalensen af Merisone med referencelægemidlet, 
• 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;
Ansøgningen om markedsføringstilladelse for Merisone blev indgivet i henhold til artikel 10, stk. 1, i direktiv 2001/83/EF (dvs. en generisk ansøgning) med Mydeton (Gedeon Richter Plc) som referencelægemiddel. 
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).
Da virkningen af disse hjælpestoffer vil blive udtyndet ved tilstedeværelse af føde, blev det fundet usandsynligt, at hjælpestoffer såsom mannitol ville have større betydning under postprandiale end under fastende betingelser, da virkningen af mannitol skyldes dets osmotiske effekt. 
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.
anbefalede CHMP udstedelse af markedsføringstilladelsen, for hvilken produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til den endelige version, der er fastlagt ved behandlingen i koordinationsgruppen for Merisone og relaterede navne (se bilag I). 
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).
Fastende bioækvivalensundersøgelser måtte derfor forventes at være mere følsomme over for forskelle betinget af formuleringen. 
Therefore it was considered that fasting bioequivalence studies are expected to be more sensitive to detect formulation differences.
• udvalget konkluderede derfor ved en flertalsafgørelse, at de udførte fastende bioækvivalensundersøgelser giver tilstrækkelig evidens til at drage konklusioner om bioækvivalens også i postprandial tilstand, eftersom Merisone indeholder et højopløseligt og højpermeabelt aktivt stof, og eftersom farmakokinetiske principper og overbevisende eksperimentel evidens viser, at effekten af fødeindtagelse for tolperison er uafhængig af formuleringen, 
• Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Merisone contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Den indsigende berørte medlemsstat fandt, at den lighed, der er påvist mellem de to forskellige ovennævnte produkter hvad angår omfanget af effekten af fødeindtagelse, ikke nødvendigvis gør sig gældende for denne generiske formulering, da det ikke er påvist, at virkningen af fødeindtagelse er en egenskab ved det aktive stof og ikke en formuleringsbetinget faktor. 
The objecting concerned member state (CMS) was of the view that a similar extent of the food effect that was shown for the two different products referred to above, does not have to hold true for this generic formulation since it has not been proven that the food effect is a characteristic of the active substance and not a formulation related factor.
Størstedelen af CHMP's medlemmer fandt, at forskelle mellem formuleringers in vivo-opløselighed normalt er mindre fremtrædende og vanskeligere at iagttage under postprandiale betingelser, da den gastriske tømningstid er længere i postprandial end i fastende tilstand. 
The majority of the CHMP members agreed that in vivo dissolution differences between formulations are likely to be less apparent and more difficult to observe in fed conditions since gastric emptying time is longer in the fed state than in the fasting state.
Da variationskoefficienten for den intraindividuelle variation er over 30 %, mente ansøgeren, at der i henhold til de gældende retningslinjer for bioækvivalensundersøgelser kunne have været påvist bioækvivalens med udvidede grænser, i dette tilfælde 71,25 %-140,35 %. 
Because the within-subject coefficient of variation is higher than 30%, the applicant was of the view that according to the current bioequivalence guideline extended limits could have been used to show bioequivalence, which would have been in this case 71.25%
Desuden blev det fremført, at der tilbagestod alvorlige betænkeligheder med hensyn til, om testproduktet (som anvises at skulle indtages sammen med et måltid) i dette tilfælde er bioækvivalent under postprandiale betingelser, i betragtning af, at resultaterne af bioækvivalensundersøgelserne i fastende tilstand lå på grænsen. 
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.
I betragtning af, at markedsføringstilladelsesindehaverne havde forelagt data, der viste, at tolperison er højopløseligt og meget permeerende, kan hverken opløselighed eller opløsning anses for at være en begrænsende faktor for in vivo-absorptionen. 
Taking into account that the MAH had submitted data which showed that tolperisone is a highly soluble and highly permeable active substance, neither solubility nor dissolution was considered to be a limiting factor in terms of in vivo absorption.
De oplysninger, der blev indført i produktresuméet for tolperison, byggede på to veltilrettelagte undersøgelser med forskellige tabletformuleringer, som viste, at et fedtrigt måltid øger biotilgængeligheden af tolperison med ca. 100 % i forhold til fastende tilstand. 
The information that was introduced in the SmPC of tolperisone was based on two well-designed studies conducted with different formulations of tablets, which showed that compared to the fasting state, fat-rich food increases the bioavailability of tolperisone by about
Da der ikke er evidens for, at effekten af fødeindtagelse er formuleringsafhængig, og da formuleringen er konventionel, kunne nogle medlemmer af PKWP acceptere en fastende bioækvivalensundersøgelse i dette tilfælde. 
As there is no evidence that the food-effect is formulation dependent and the formulation is a conventional one, some of the PKWP members considered that a bioequivalence study in the fasting state was acceptable in this case.
For de primære farmakokinetiske parametre, dvs. AUC og Cmax, blev der påvist bioækvivalens af 150 mg tabletten, idet 90 % sikkerhedsintervallet lå inden for de foreskrevne grænser 80-125 %. 
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.
Da produktresuméet for referencelægemidlet ikke indeholdt anbefalinger om fødeindtagelse og ikke omtalte en effekt af fødeindtagelse, indeholdt ansøgningen om markedsføringstilladelse for Merisone to bioækvivalensundersøgelser, der blev udført med filmovertrukne tabletter med tolperison, 50 og 150 mg, begge med 52 forsøgspersoner under fastende betingelser. 
Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Merisone included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Skønt den indsigende medlemsstat anså resultaterne af bioækvivalensundersøgelserne for at være på grænsen, fremførte ansøgeren, at designet af den anden bioækvivalensundersøgelse var en gentagelse, og at undersøgelsen viste, at tolperison er omfattet af stor variation - den intraindividuelle variabilitet af Cmax for referencelægemidlet var 46,99 %. 
Although the results of the bioequivalence studies were considered to be borderline by the objecting CMS, the applicant argued that the second bioequivalence study was a replicate design study where it was shown that tolperisone is a highly variable drug - the within-subject variability of the reference medicinal product Cmax was 46.99%.
Da der ikke er evidens for, at virkningen af fødeindtagelse afhænger af formuleringen, konkluderede et flertal i CHMP, at bioækvivalensundersøgelser i fastende tilstand (som anses for den mest følsomme betingelse) i dette tilfælde er tilstrækkelig evidens som grundlag for en konklusion om bioækvivalens i både fastende og postprandial tilstand. 
As there is no evidence that the food-effect is formulation dependent, the majority of the CHMP concluded that the bioequivalence studies conducted in the fasting state, which is considered to be the most sensitive condition, would give sufficient evidence to conclude on the bioequivalence in both the fasting and fed states in this particular case.
Den indsigende medlemsstat fandt derfor, at de to bioækvivalensundersøgelser, der var forelagt med 50 og 150 mg tolperison tabletter i fastende tilstand, var utilstrækkelige, og at der burde påvises bioækvivalens under postprandiale betingelser. 
Therefore the objecting member state was of the view that the two bioequivalence submitted with the 50 and 150mg tolperisone tablets under fasting conditions were not sufficient, and that bioequivalence should be demonstrated under fed conditions.
Ansøgeren fremhævede, at på tidspunktet for udførelsen af bioækvivalensundersøgelserne indeholdt produktresumeet for referencelægemidlet ingen anbefalinger om fødeindtagelse eller omtale af betydningen heraf. 
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.
Under hensyn til al den fremførte evidens og argumentation konstaterede et flertal af udvalgets medlemmer, at der var påvist fastende bioækvivalens for tolperison, som er højopløseligt og højpermeabelt og udviser stor intraindividuel variation. 
Taking into account all the evidence and arguments presented, the majority of the CHMP noted that that bioequivalence had been demonstrated in the fasting state for tolperisone, which is highly soluble and highly permeable active substance, demonstrating high within-subject variability.
I undersøgelsen med 50 mgtabletten blev der ikke påvist bioækvivalens, da den øvre grænse for Cmax var 125,49 %, dvs. uden for den foreskrevne værdi. 
In the study with the 50 mg tablet, bioequivalence was not demonstrated as the upper limit of the Cmax was outside the upper band, i.e.
CHMP bemærkede også, at hjælpestofferne mannitol og betain, som fandtes i produktet omfattet af indbringelsen, men ikke i referencelægemidlet, var uden indflydelse på bioækvivalensen af disse produkter ved fastende indtagelse. 
The CHMP also noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
CHMP bemærkede at hjælpestofferne mannitol og betain, der fandtes i produktet omfattet af indbringelsen, men ikke i referencelægemidlet, var uden indflydelse på den fastende bioækvivalens af disse produkter. 
The CHMP noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
Derudover blev arbejdsgruppen vedrørende farmakokinetik (PKWP) anmodet om at udtale sig om en eventuel videnskabelig begrundelse for at forvente bioækvivalens i enten fastende eller postprandial tilstand af tolperison (der klassificeres som et stærkt variabelt lægemiddel, da den intraindividuelle variabilitet af Cmax for referencelægemidlet var 46,99 %). 
The Pharmacokinetics Working Party (PKWP) was also consulted to seek their view on whether there is any scientific reasoning that tolperisone (classified as a highly variable drug as the within-subject variability of the Cmax of the reference medicinal product was 46.99%) may have the option of showing bioequivalence in either the fasted or fed state.
På grundlag af de forelagte bioækvivalensundersøgelse fandt CHMP's medlemmer derfor, at tabletterne med tolperison, 50 og 150 mg ved fastende indtagelse er bioækvivalente med referencelægemidlet Mydeton, tabletter, 50 og 150 mg (Gedeon Richter Plc). 
Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Merisone 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
• udvalget fandt, at de forelagte bioækvivalensundersøgelse viste, at Merisone, tabletter, 50 og 150 mg, under fastende betingelser var bioækvivalente med referencelægemidlet Mydeton, tabletter, 50 og 150 mg, 
• The Committee was of the view that results of the submitted bioequivalence studies showed that Merisone 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Andre medlemmer af PKWP var den opfattelse, at en postprandial undersøgelse kun var overflødig, hvis virkningen af fødeindtagelse udelukkende var hepatisk, hvilket der imidlertid ikke fandtes at være tilstrækkeligt grundlag for. 
Other PKWP members were of the view that a fed study would not have been required only if the effects of food were known to be solely hepatic, which however was considered to be insufficiently supported, and since the food effect for tolperisone was considered to be significantly high, a study in a fed state should have been performed.
Dette fremgik af produktresuméet for referencelægemidlet på ansøgningstidspunktet for den markedsføringstilladelse, som denne indbringelse vedrører1. 
However more recently the effect of food on the bioavailability of tolperisone has been established to be significant and was reflected accordingly in the SmPC of the reference medicinal product at the time of submission of the MAA subject to this referral1.
Fortæl det til din læge, hvis du bliver gravid under behandlingen. 
Tell your doctor if you become pregnant during treatment.
Hyppighederne defineres som: 
The frequencies are defined as:
• Behandlingen starter normalt med en lav dosis. 
Treatment usually starts with a low dose.
Proteinbinding af rivastigmin er ca. 40 %. 
Protein binding of rivastigmine is approximately 40 %.
Din læge vil fortælle dig, hvilken dosis Rivastigmin Teva du skal tage. 
Your doctor will tell you what dose of Rivastigmine Teva to take.
Gennemsnitsændring ved 24 uger ± SD 
Mean change at 24 weeks ± SD
Øvrige indholdsstoffer er: 
The other ingredients are:
• Din læge vil gradvist øge din dosis afhængigt af, hvordan du reagerer på behandlingen. 
Your doctor will slowly increase your dose depending on how you respond to the treatment.
Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemetunder modul 1.8.1. i ansøgningen om markedsføringstilladelsen, er i orden og fungerer inden og mens produktet er på markedet. 
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Bivirkningerne i tabel 1 er ordnet ifølge MedDRA-systemorganklasser og frekvenskategorier. 
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Sidste udførte observation (Last Observation Carried Forward) 
Last Observation Carried Forward
De fleste tilfælde af tilfældig overdosering har ikke været forbundet med kliniske tegn eller symptomer, og næsten alle de pågældende patienter fortsatte behandlingen med rivastigmin. 
Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment.
Patienter med klinisk signifikant respons (%) Behandlingsintention (Intent to Treat) 
Patients with Clinically Significant Response (%) Intent to Treat
• Du skal tage medicinen hver dag for at få gavn af den. 
To benefit from your medicine, take it every day.
Brug ikke Rivastigmin Teva efter den udløbsdato, der står på pakningen. 
Do not use Rivastigmine Teva after the expiry date that is stated on the carton.
Disse hændelser førte til seponering af rivastigmin i nogle tilfælde (f.eks. seponering grundet tremor 1,7 % på rivastigmin versus 0 % på placebo). 
These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7 % on rivastigmine vs 0 % on placebo).
I tilfælde af alvorlig opkastning, der er associeret med rivastigmin-behandling, skal der foretages passende dosisjustering som anbefalet i afsnit 4.2. 
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
ADAS-Cog Placebo Patienter uden visuelle hallucinationer 
ADAS-Cog Placebo Patients without visual hallucinations