FrancophonIA/ELRC3.0 huggingface dataset:
English: TARGET SPECIES Male pigs (from 8 weeks of age).
Slovenian: CILJNE ŽIVALSKE VRSTE Prašiči, samci (od 8. tedna starosti).
English: PHARMACEUTICAL FORM Solution for injection
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 2 ml, by subcutaneous injection (injection given under the skin).
Slovenian: 2 ml, subkutana injekcija (injekcija dana pod kožo).
English: DEAE-Dextran Chlorocresol Urea
Slovenian: DEAE-dekstran Klorokrezol
English: Outer packaging:
Slovenian: Zunanja ovojnina:
English: Do not use in female or male breeding pigs.
Slovenian: Ne uporabite pri ženskih ali moških vzrejnih živalih.
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Zoetis Belgium SA
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: − zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Male pigs (from 8 weeks of age).
Slovenian: Prašiči, samci (od 8 tedna starosti)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Slovenian: Nenamerno samo-injiciranje je nevarno.
English: GnRF analogue-protein conjugate: Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: GnRF - DT - konjugat: Zoetis Belgium SA
English: PACKAGE SIZE 1 x 100 ml
Slovenian: VELIKOST PAKIRANJA 1 x 100 ml
English: Synthetic GnRF peptide analogue: Auspep Clinical Peptides PTY Ltd. 15, Mareno Road, Tullamarine, 3052 Victoria
Slovenian: Auspep Clinical Peptides PTY Ltd.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 1 x 100 ml and 1 x 250 ml HDPE bottles
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla, , 1 x 100 ml in 1 x 250 ml HDPE steklenice
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/09/095/002 - 10 x 100 ml EU/2/09/095/003 - 4 x 250 ml
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/095/005 - 100 ml
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/09/095/005 - 100 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, 10 x 100 ml and 4 x 250 ml HDPE bottles
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla, , 10x100 ml in 4x250 ml HDPE steklenice
English: Pack sizes:
Slovenian: Velikost ovojnine:
English: Gonadotropin releasing factor (GnRF) analogue-protein conjugate min. 300 µg.
Slovenian: Analog gonadotropin sproščajočega faktorja (GnRF) - konjugiran protein min. 300 µg
English: The veterinary medicinal product should be stored safely out of the reach of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom.
English: BELGIUM
Slovenian: Zoetis Belgium SA
English: Cardboard box with 10 bottles of 100 ml.
Slovenian: Kartonska škatla z 1 plastenko s po 100 ml. Kartonska škatla z 10 plastenkami s po 100 ml.
English: Pharmacotherapeutic group: Gonadotropin releasing factor analogue, conjugated.
Slovenian: Farmakoterapevtska skupina: Analog gonadotropin sproščujočega faktorja, konjugiran, oznaka ATC vet: QG03XA91.
English: STATEMENT OF ACTIVE SUBSTANCES GnRF analogue-protein conjugate min. 300 µg/2 ml
Slovenian: GnRF analog - konjugiran protein najmanj 300 µg/2ml
English: EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Slovenian: Načeto zdravilo uporabite v 28 dneh.
English: Cardboard box with 4 bottles of 250 ml.
Slovenian: Kartonska škatla s 1 plastenko s po 250 ml. Kartonska škatla s 4 plastenkami s po 250 ml.
English: Diphtheria toxoid:
Slovenian: Sintetični GnRF peptid:
English: − common (more than 1 but less than 10 animals in 100 animals treated)
Slovenian: − pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Slovenian: − redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
English: 6.1 List of excipient(s)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: The patient should be advised not to administer Improvac and/or any other product with similar action in the future.
Slovenian: Improvac-a in/ali zdravil s podobnim delovanjem.
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Slovenian: − občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali)
English: A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Slovenian: Pri dajanju prašičem pri najnižji priporočeni starosti (8 tednov), so bile na mestu dajanja zelo pogosto opazne otekline do 4x8 cm. Lokalna reakcija postopno izgine, vendar pri 20-30 % živalih lahko ta ostane več kot 42 dni.
English: AUSTRALIA
Slovenian: Sečnina
English: Excipient: Chlorocresol
Slovenian: klorokrezol
English: After first broaching with a sterile needle, the container should be returned to the refrigerator.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: po prvem odpiranju s sterilno iglo morajo vsebnik vrnete v hladilnik in ga nato v naslednjih 28 dneh še enkrat odprete, nato pa zavržete takoj po uporabi.
English: − very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Slovenian: − zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
English: Zoetis LLC
Slovenian: Rp-Vet.
English: Immediate packaging:
Slovenian: Stična ovojnina:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml and 250 ml HDPE bottles
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI 100 ml in 250 ml HDPE stekleničke
English: PACKAGE SIZE 10 x 100 ml 4 x 250 ml
Slovenian: VELIKOST PAKIRANJA 10 x 100 ml
English: Ref. EMEA/4193/2008
Slovenian: EMEA/90152/2008
English: This means that they were to be similar to biological medicines that are already authorised in the European Union (EU) and contain the same active substances (also known as the ‘reference medicines').
Slovenian: To pomeni, da bi naj bila podobna biološkim zdravilom, ki so že odobrena v Evropski uniji (EU) in vsebujejo isto zdravilno učinkovino (imenovanim tudi „referenčna zdravila“).
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Pismo podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
English: What were these medicines expected to be used for?
Slovenian: Za kaj naj bi se zdravila uporabljala?
English: The three ‘Marvel insulins' were to contain one or both types of insulin:
Slovenian: Trije „insulini Marvel“ naj bi vsebovali eno ali obe vrsti insulina:
English: These three medicines are all solutions for injection that contain 100 International Units of insulin per millilitre.
Slovenian: Ta tri zdravila so raztopine za injiciranje, ki vsebujejo 100 mednarodnih enot insulina na mililiter.
English: International non-proprietary name (INN): human insulin
Slovenian: Mednarodno nelastniško ime (INN): humani insulin
English: These medicines would have contained insulin in two different forms: a soluble form, which acts quickly (within 30 minutes of injection), and an ‘isophane' form, which is absorbed more slowly and gives a longer duration of action.
Slovenian: Zdravila bi vsebovala insulin v dveh različnih oblikah: v topni obliki, ki učinkuje hitro (v 30 minutah po injiciranju), ter v „izofani“ obliki, ki se absorbira počasneje ter posledično zagotavlja daljše trajanje učinkovanja.
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Slovenian: CHMP je pripravil seznam vprašanj, na katera naj bi podjetje odgovorilo, vendar tega do sedaj še ni storilo.
English: The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Slovenian: Referenčna zdravila za te insuline bi naj bila Humulin S, Humulin I and Humulin M3.
English: They were to be available in vials or as cartridges to be used in injection pens.
Slovenian: Na voljo naj bi bila v vialah ali vložkih, namenjenih za uporabo kot injekcijski peresniki.
English: How are these medicines expected to work?
Slovenian: Kako naj bi zdravila delovala?
English: The CHMP was also concerned that the company had not supplied enough information on how the active substance or the finished products are made, and that the processes used to make them had not been validated.
Slovenian: CHMP je imel tudi zadržke v zvezi z dejstvom, da podjetje ni posredovalo dovolj informacij o tem, kako se zdravilna učinkovina ali končni izdelek proizvaja, ter da procesi, ki se uporabljajo za njuno proizvodnjo, niso validirani.
English: The active substance, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Slovenian: Zdravilna učinkovina, humani insulin, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNA“: proizvaja ga bakterija, ki je prejela gen (DNA), s pomočjo katerega tvori insulin.
English: The main measure of effectiveness was the effect of the medicines on the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: Glavno merilo učinkovitosti je bil vpliv zdravil na raven snovi, imenovane glikoziliran hemoglobin (HbA1c), v krvi, ki kaže, kako dobro je glukoza v krvi nadzorovana.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
English: The medicines were expected to be used to treat patients with diabetes who need insulin to maintain their blood levels within normal levels, and to control diabetes in newly diagnosed patients and pregnant women.
Slovenian: Zdravila naj bi se uporabljala za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje koncentracije sladkorja v krvi v normalnem območju, ter za nadzor sladkorne bolezni pri nanovo diagnosticiranih bolnikih in nosečnicah.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije sladkorja v krvi.
English: The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Slovenian: Podjetje je predložilo podatke iz študij, zasnovanih z namenom, da bi dokazali, da so insulini Marvel primerljivi z referenčnimi zdravili, in sicer tako na eksperimentalnih modelih kot pri ljudeh.
English: It also presented the results of one main study in 526 patients with diabetes, who received either the Marvel insulins or the Humulin insulins for up to 12 months.
Slovenian: Podjetje je poleg tega predložilo rezultate ene glavne študije s 526 bolniki s sladkorno boleznijo, ki so do 12 mesecev prejemali ali insuline Marvel ali insuline Humulin.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes currently with the Marvel insulins.
Slovenian: Podjetje je CHMP obvestilo, da klinična preizkušanja ali programi sočutne uporabe insulinov Marvel trenutno ne potekajo.
English: The main concerns of the CHMP were that the comparability of the Marvel insulins and the Humulin insulins had not been shown.
Slovenian: Glavni zadržki CHMP so bili povezani dejstvom, da primerljivost insulinov Marvel in insulinov Humulin ni bila dokazana.
English: The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin.
Slovenian: Raziskave z zdravimi prostovoljci niso dokazale, da bi imeli insulini Marvel enak vpliv na zniževanje ravni sladkorja v krvi kot insulini Humulin, glavna raziskava pa je izkazala trend v prid insulinov Humulin.
English: The company presented the results of studies carried out in 24 healthy volunteers looking at the effect of the Marvel insulins on blood sugar levels, compared with the Humulin insulins.
Slovenian: Podjetje je predložilo rezultate študij, izvedenih s 24 zdravimi prostovoljci, v katerih so preučevali učinek insulinov Marvel na raven sladkorja v krvi v primerjavi z insulini Humulin.
English: The application was at day 120 when the company withdrew.
Slovenian: Podjetje je vlogo umaknilo na 120. dan postopka.
English: • Insulin Human 30/70 Mix Marvel: 30% soluble insulin and 70% isophane insulin.
Slovenian: • Insulin Human 30/70 Mix Marvel: 30 % topnega insulina in 70 % insulina izofana.
English: • Insulin Human Rapid Marvel: soluble insulin,
Slovenian: • Insulin Human Rapid Marvel: topni insulin,
English: On 20 December 2007, Marvel LifeSciences Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, for the treatment of diabetes mellitus.
Slovenian: Podjetje Marvel LifeSciences Ltd. je dne 20. decembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vloge za izdajo dovoljenj za promet z zdravili Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel, namenjenimi za zdravljenje sladkorne bolezni.
English: Therefore, at the time of the withdrawal, the CHMP's view was that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not be considered as biosimilar to the reference medicinal products Humulin S, Humulin I and Humulin M3.
Slovenian: CHMP je bil zato v času umika mnenja, da zdravil Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel ni mogoče obravnavati kot podobna referenčnim zdravilom Humulin S, Humulin I and Humulin M3.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravila INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
English: Based on the review of the data, the CHMP had some concerns and was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus.
Slovenian: Na podlagi pregleda podatkov je imel CHMP določene zadržke in bil začasnega mnenja, da za zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel ni mogoče odobriti dovoljenja za zdravljenje sladkorne bolezni.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Insulin Human Rapid Marvel, Insulin Human Long Marvel or Insulin Human 30/70 Mix Marvel?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravil Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel?
English: • Insulin Human Long Marvel: isophane insulin,
Slovenian: • Insulin Human Rapid Marvel: insulin izofan,
English: What are Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel?
Slovenian: Kaj so zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel?
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel were to be ‘biosimilar' medicines.
Slovenian: Zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel naj bi bila „podobna biološka“ zdravila.
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel are replacement insulins, which contain an active substance that is identical to the insulin made by the pancreas.
Slovenian: Zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel so nadomestni insulini, ki vsebujejo zdravilno učinkovino, enako insulinu, ki ga tvori trebušna slinavka.
English: A procedure under Article 29(4) was therefore triggered in June 2012.
Slovenian: Zato se je junija 2012 začel postopek na podlagi člena 29(4).
English: Glimepiride has been authorised in the EU since 1996.
Slovenian: V EU je odobren od leta 1996.
English: This implies that the composition of the different strengths will have the same impact on the in vivo absorption.
Slovenian: To pomeni, da bo imela sestava pri različnih jakostih enak učinek na absorpcijo in vivo.
English: • the CHMP reviewed the available data and the justifications submitted by the Applicant,
Slovenian: • Odbor CHMP je pregledal dostopne podatke in utemeljitve predlagatelja;
English: Overall summary of the scientific evaluation of Glimepirida Parke-Davis and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Glimepirida ParkeDavis in povezanih imen (glej Prilogo I)
English: The Applicant therefore only performed the required bioequivalence studies.
Slovenian: Torej je izvedel le zahtevane študije biološke enakovrednosti.
English: Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Slovenian: Nazadnje je še navedel, da glimepirid kaže linearne farmakokinetične lastnosti.
English: Regarding the risk for incomplete dissolution, the CHMP considered that the test and reference formulations exhibited a similar performance, indicating a similar risk for all formulations.
Slovenian: Kar zadeva tveganje nepopolnega raztapljanja, je menil, da sta se testna in referenčna formulacija obnašali podobno, kar kaže na podobno tveganje za vse formulacije.
English: As a result, all tablet strengths have the same average weight (170 mg) and identical qualitative and quantitative composition in terms of functional excipients, with the exception of small differences in the quantity of the filler lactose monohydrate, which is used proportionally to compensate for the differences in the active substance content (less than 5 % of the total tablet weight) resulting from the range of tablet strengths.
Slovenian: Posledično imajo vse jakosti tablet enako povprečno maso (170 mg) ter enako kakovostno in količinsko sestavo z vidika funkcionalnih pomožnih snovi, razen manjših razlik v količini polnila laktoza monohidrata, ki se uporablja sorazmerno za izravnavo razlik v vsebnosti zdravilne učinkovine (manj kot 5 % skupne mase tablet), kar je posledica različnih jakosti tablet.
English: Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
Slovenian: V zvezi z velikostjo delcev zdravilne učinkovine je navedel, da se uporablja mikronizirani glimepirid, kar pomeni, da je 95 % delcev manjših od 10 μm, 50 % delcev pa manjših od 4 μm.
English: Glimepiride is a second generation sulphonylurea anti-hyperglycaemic agent used in patients with type 2 diabetes mellitus insufficiently controlled by diet and exercise alone or in combination with insulin in patients in whom diet and exercise plus oral anti-hyperglycaemic therapy have failed to control blood glucose.
Slovenian: Glimepirid je druga generacija antihiperglikemičnih učinkovin iz skupine sulfonilsečnin za uporabo pri bolnikih s sladkorno boleznijo tipa 2 (diabetes mellitus tipa 2), ki ni zadostno nadzorovana samo z dieto in telesno dejavnostjo, ali za uporabo skupaj z insulinom pri bolnikih, pri katerih z dieto in telesno dejavnostjo ter terapijo s peroralnimi antihiperglikemičnimi zdravili ni bilo mogoče nadzorovati glukoze v krvi.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Glimepirida Parke-Davis and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Glimepirida Parke-Davis in povezana imena (glej Prilogo I).
English: The Applicant submitted a marketing authorisation application for Glimepirida Parke-Davis, based on claims of essential similarity to the marketed reference product.
Slovenian: Predlagatelj je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Glimepirida Parke-Davis na podlagi trditev o bistveni podobnosti z referenčnim zdravilom na trgu.
English: In addition, the fraction of absorbed glimepiride is consistently described as being non dose-dependent and close to 100%, as evidenced from the rapid and complete absorption from the gastro-intestinal tract with linear increase in Cmax and AUC.
Slovenian: Poleg tega se frakcija absorbiranega glimepirida dosledno opisuje kot neodvisna od odmerka in skoraj 100-odstotna, kar se kaže v hitri in popolni absorpciji v prebavnem traktu z linearnim povečevanjem največje koncentracije (Cmax) in površine pod krivuljo (AUC).
English: The Applicant also stated that the proposed tablets are developed as look-alike formulations.
Slovenian: Navedel je še, da so predlagane tablete zasnovane na podlagi „dvojniških formulacij“.
English: The CHMP considered that the dissolution studies confirmed that the low dissolution of glimepiride is related to the drug substance rather than to the formulation and that all strengths of the proposed product have similar qualitative and quantitative compositions, leading to similar in vivo absorption.
Slovenian: Pri tem je menil, da so študije v zvezi z raztapljanjem potrdile, da se slaba topnost glimepirida navezuje na zdravilno učinkovino in ne na formulacijo ter da imajo vse jakosti predlaganega zdravila enako kakovostno in količinsko sestavo, kar vodi do podobne absorpcije in vivo.
English: The CHMP was therefore of the opinion that the benefit-risk ratio of Glimepirida Parke-Davis and associated names is favourable.
Slovenian: Zato je po njegovem mnenju razmerje med koristmi in tveganji zdravila Glimepirida Parke-Davis in povezanih imen ugodno.
English: • the CHMP considered the conducted bioequivalence study to be adequate to demonstrate bioequivalence between the proposed and the reference products,
Slovenian: • Menil je, da je bila izvedena študija biološke enakovrednosti primerna kot dokaz biološke enakovrednosti med predlaganim in referenčnim zdravilom;