FrancophonIA/ELRC3.0 huggingface dataset:
English: While there was a treatment-related reduction in time to radiographic fracture union, there was no difference over time between the TruScient treated group and the control group for the individual clinical parameters, lameness and pain, or for an overall score based on clinical signs of fracture healing.
Slovenian: Čeprav je bilo dokazano, da zdravljenje zmanjša čas do radiografsko potrjene zacelitve kosti, pa glede posameznih kliničnih parametrov, šepanja in bolečine oziroma skupne ocene, ki je temeljila na kliničnih znakih celjenja kosti, sčasoma ni bilo razlike med skupino, ki je prejela TruScient in kontrolno skupino.
English: The incidence of antibody titres in treated dogs under field conditions is low and the puppies will have no or very limited exposure to anti-BMP-2 antibodies due to the potential for limited transfer across the placenta in dogs.
Slovenian: Incidenca titrov protiteles pri zdravljenih psih na terenu je nizka, zaradi morebitnega omejenega prenosa protiteles skozi placento pri psih, mladiči protitelesom anti-BMP-2 ne bodo izpostavljeni, oziroma bodo izpostavljeni v zelo omejenem obsegu.
English: TruScient 0.66 mg kit for implant for dogs dibotermin alfa (rhBMP-2)
Slovenian: TruScient 0,66 mg komplet za implantacijo za pse dibotermin alfa (rhBMP-2)
English: Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Slovenian: Za oskrbo zlomov dolgih kosti in poškodb mehkih tkiv uporabite standardne postopke, vključno z obvladovanjem okužb.
English: The following adverse reactions have been observed in a field study in dogs:
Slovenian: V študijah pri psih na terenu so opazili naslednje neželene učinke:
English: Dibotermin alfa (rhBMP-2) is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation.
Slovenian: Dibotermin alfa je osteo-induktiven protein, ki spodbuja nastajanje novega kostnega tkiva na mestu implantacije.
English: One vial of lyophilisate contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala z liofilizatom vsebuje:
English: This veterinary medicinal product should be used by an appropriately qualified veterinarian.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih To zdravilo za uporabo v veterinarski medicini sme uporabljati samo ustrezno usposobljen doktor veterinarske medicine.
English: Using aseptic transfer technique and for each 3 ml syringe with needle, withdraw 1.4 ml from the reconstituted vial of dibotermin alfa (rhBMP-2) in the non-sterile field.
Slovenian: Z uporabo aseptične tehnike v vsako od 3-ml brizg potegnite 1,4 ml iz viale z rekonstituirano raztopino dibotermina alfa (rhBMP-2) v nesterilnem območju.
English: The following adverse reactions have been observed in laboratory studies in dogs: o Heterotopic ossification of the surrounding tissues o Exuberant bone formation at the site of placement and ectopic bone formation o Excessive bone and fluid filled cysts that remodel into normal bone over time o Increased swelling at the site of placement has been observed by 2-3 weeks post surgery.
Slovenian: V laboratorijskih študijah pri psih so opazili naslednje neželene učinke: - heterotopična osifikacija okolnih tkiv - bohotenje kosti na mestu implantacije in ektopično nastajanje kostnine - povečan nastanek kostnih cist in cist, napolnjenih s tekočino, ki se s časom spremenijo v normalno kostnino - močnejšo oteklino na mestu implantacije so opazili 2-3 tedne po operaciji; otekline so posledica lokalne proliferacije mezenhima, ki zori v novo kostnino, kar je v skladu s farmakološkim delovanjem rhBMP-2.
English: A. Reconstitute dibotermin alfa (rhBMP-2) in a non-sterile field: 1.
Slovenian: A. Rekonstitucija dibotermina alfa (rhBMP-2) v nesterilnem območju: 1.
English: If a surgical drain is required, place the drain at least one layer superficial to or remote from the prepared sponge.
Slovenian: Če je potrebna kirurška drenaža, namestite dren eno plast nad mestom implantacije ali daleč stran od mesta implantacije.
English: Do not use in dogs with a known hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
English: Figure 1: Reconstitution of dibotermin alfa (rhBMP-2)
Slovenian: Slika 1: Rekonstitucija dibotermina alfa (rhBMP-2)
English: D. After Placement
Slovenian: D. Po implantaciji
English: Peel open the inner package of sponges and leave them in the tray.
Slovenian: Odprite stično ovojnino gobic in ju pustite na pladnju.
English: LYOPHILISATE VIAL LABEL
Slovenian: NALEPKA ZA VIALO Z VEHIKLOM
English: Use within 2 hours of wetting the sponges.
Slovenian: Uporabite v 2 urah po pripravi.
English: Read the instructions below each time the veterinary medicinal product is used.
Slovenian: Pred vsako uporabo zdravila preberite spodnja navodila.
English: Uncommon (more than 1 but less than 10 animals in 1000 animals) Mild to moderate Exuberant bony callus associated with persistent (>10 weeks) moderate soft tissue swelling and excessive licking of the incision area.
Slovenian: Občasni (pojavijo se pri več kot 1 živali, vendar pri manj kot 10 od 1000 živali ) Blagi do zmerni povečam kostni kalus ter stalna (več kot 10 tednov) zmerna oteklina mehkega tkiva ter močno lizanje območja rane
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Rue Laid Burniat 1
English: Spain
Slovenian: España
English: In the absence of compatibility studies, this veterinary medicinal product must be reconstituted only with the solvents provided and should not be mixed with other solvents or other veterinary medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
English: Using the 6 ml syringe and needle, withdraw 3.2 ml of solvent (more solvent is supplied than is needed).
Slovenian: Z uporabo 6 ml-brizge in igle v brizgo potegnite 3,2 ml vehikla (v viali je večja količina vehikla kot je potrebno).
English: The dibotermin alfa (rhBMP-2) is reconstituted to 0.2 mg/ml solution and then distributed uniformly across both sponges.
Slovenian: Dibotermin alfa (rhBMP-2) rekonstituirajte z 0,2 mg/ml raztopine in nato nastalo raztopino enakomerno nanesite na obe gobici.
English: Directions: Using aseptic technique, follow the directions below to reconstitute dibotermin alfa (rhBMP-2) for application to the sponges.
Slovenian: Navodila: Z uporabo aseptične tehnike sledite spodnjim navodilom za rekonstitucijo dibotermina alfa (rhBMP-2) za nanašanje na gobici.
English: 2 absorbable collagen sponges 2 sterile 3 ml disposable syringes with needles 1 sterile 6 ml disposable syringe with needle
Slovenian: 2 sterilni 3-ml brizgi za enkratno uporabo z iglama 1 sterilna 6-ml brizga za enkratno uporabo z iglo
English: Using aseptic technique, follow the directions below to reconstitute dibotermin alfa (rhBMP-2) for application to the sponges.
Slovenian: Z uporabo aseptične tehnike sledite spodnjim navodilom za rekonstitucijo dibotermina alfa (rhBMP-2) za nanašanje na gobici.
English: 10 ml Type I glass vial with a chlorobutyl elastomeric closure sealed with an aluminum flipoff seal and plastic cap.
Slovenian: 10-ml viala is stekla tipa I z zamaškom iz klorobutilnega elstomera, neprodušno zaprta z aluminijasto zaščitno zaporko in plastičnim pokrovčkom
English: Failure to follow the TruScient instructions for preparation and use may compromise safety and effectiveness.
Slovenian: Neupoštevanje navodil za pripravo in uporabo TruScient lahko ogrozi njegovo varnost in učinkovitost.
English: Prepare sponges at least 15 minutes prior to use from components contained in the kit.
Slovenian: Gobici je treba s pomočjo ostalih sestavin, ki so v kompletu, pripraviti vsaj 15 minut pred uporabo.
English: The possibility of an immune response to the product should be evaluated in cases where an undesirable effect with immunological background is suspected.
Slovenian: V primerih suma, da so neželeni učinki imunološkega porekla, je treba oceniti možnost imunskega odgovora na zdravilo.
English: Type I bovine collagen
Slovenian: Goveji kolagen tipa I
English: PACKAGE LEAFLET FOR: TruScient 0.66 mg kit for implant for dogs
Slovenian: NAVODILO ZA UPORABO TruScient 0,66 mg komplet za implantacijo za pse
English: Use care to ensure that accurate volumes are used in reconstitution and application of the dibotermin alfa (rhBMP-2) solution to the sponge.
Slovenian: Zagotovite, da so uporabljene ustrezne količine pri rekonstituciji in nanašanju raztopine dibotermina alfa (rhBMP-2) na gobici.
English: During handling, avoid excessive fluid loss from the prepared sponges.
Slovenian: Pazite, da med ravnanjem s pripravljenimi gobicami iz njih ne izteče preveč tekočine.
English: After reconstitution, TruScient solution contains 0.2 mg/ml of dibotermin alfa (rhBMP-2).
Slovenian: Po rekonstituciji TruScient vsebuje 0,2 mg/ml dibotermina alfa (rhBMP-2).
English: Read the instructions for preparation and use below each time the veterinary medicinal product is used.
Slovenian: Pred vsako uporabo zdravila preberite navodila za pripravo in uporabo.
English: Failure to follow the product preparation instructions may compromise its safety and effectiveness.
Slovenian: Neupoštevanje navodil za pripravo lahko ogrozi varnost in učinkovitost zdravila.
English: Achieve definitive fracture reduction, fixation, and hemostasis prior to placement of the prepared sponge.
Slovenian: Pred implantacijo pripravljene gobice je treba doseči dokončno redukcijo zloma, fiksacijo in hemostazo.
English: One vial of lyophilisate contains 0.66 mg of dibotermin alfa (rhBMP-2)*
Slovenian: Ena viala z liofilizatom vsebuje 0,66 mg dibotermina alfa (rhBMP-2).
English: ABSORBABLE COLLAGEN SPONGE LABEL
Slovenian: NALEPKA ZA KOLAGENSKO GOBO
English: The maximum recommended dosage is the entire contents of a single TruScient kit for each dog (i.e., up to two 2.5 x 5 cm prepared TruScient sponges per dog).
Slovenian: Največji priporočeni odmerek je celotna vsebina enega kompleta za implantacijo za enega psa (t.j.
English: Discard any unused veterinary medicinal product.
Slovenian: Neuporabljeno zdravilo zavrzite.
English: The prepared sponge may be wrapped around the bone or placed up to the edges of a bone plate as the geometry of the fracture and fixation requires.
Slovenian: Glede na geometrijo zloma in fiksacijo lahko pripravljeno gobico ovijete okoli kosti ali jo namestite do robov ploščice.
English: Disinfect with alcohol the stoppers of the lyophilisate and the solvent vials.
Slovenian: Zamaške vial z liofilizatom in vehiklom razkužite z alkoholom.
English: Leaving the sponges in the tray, UNIFORMLY distribute onto each sponge 1.4 ml dibotermin alfa (rhBMP-2) solution as shown in the illustration (Figure 2).
Slovenian: ENAKOMERNO nanesite 1,4 ml raztopine dibotermina alfa (rhBMP-2) na vsako od obeh gobic kot je prikazano na spodnji shemi (Slika 2).
English: MARKETING AUTHORISATION HOLDER
Slovenian: Datum podaljšanja dovoljenja za promet:
English: Following placement, achieve complete soft-tissue coverage of the prepared sponges.
Slovenian: Po implantaciji poskrbite, da pripravljeno gobico popolnoma prekrijete z mehkim tkivom.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Two sterile 3 ml disposable polypropylene syringes with stainless steel needles attached.
Slovenian: Komplet vsebuje tudi: dve sterilni 3-ml polipropilenski injekcijski brizgi za enkratno uporabo s pritrjeno iglo iz nerjavečega jekla eno sterilno 6-ml polipropilensko injekcijsko brizgo za enkratno uporabo s pritrjeno iglo iz nerjavečega jekla
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega razlitja po koži ali v oči nemudoma sperite.
English: These swellings are the result of local proliferation of mesenchymal tissue maturing to new bone and are consistent with the pharmacologic activity of rhBMP-2
Slovenian: - povečan nastanek kostnih cist in cist, napolnjenih s tekočino, ki se s časom spremenijo v normalno kostnino - močnejšo oteklino na mestu implantacije so opazili 2-3 tedne po operaciji; otekline so posledica lokalne proliferacije mezenhima, ki zori v novo kostnino, kar je v skladu s farmakološkim delovanjem rhBMP-2.
English: SOLVENT VIAL LABEL
Slovenian: NALEPKA ZA VIALO Z LIOFILIZATOM
English: Gently swirl
Slovenian: Resni šepanje
English: TruScient should only be administered to the fracture site with utmost care.
Slovenian: TruScient skrbno namestite na mesto zloma.
English: White lyophilisate and a clear colourless solvent.
Slovenian: Bel liofilizat in bister brezbarven vehikel.
English: Seroma, excessive licking of incision area, joint stiffness, local swelling, skin ulcer, incisional discharge, incisional dehiscence.
Slovenian: Pogosti (pojavijo se pri več kot 1 živali, vendar pri manj kot 10 od 100 živali ) Blagi do zmerni serom, močno lizanje območja rane, otrdelost sklepov, lokalna oteklina, kožna razjeda, izcedek iz rane, dehiscenca rane mehka oteklina, ki na splošno izgine do 6. tedna po operaciji
English: The two important criteria were:
Slovenian: Dve pomembni merili sta bili:
English: CHMP's position
Slovenian: Stališče CHMP
English: Therefore the clinical conclusions should remain the same.
Slovenian: Iz tega razloga ostanejo klinični zaključki nespremenjeni.
English: Any argumentation based on the data generated at the contract laboratory is inappropriate in view of the number and seriousness of deficiencies.
Slovenian: Vsakršno utemeljevanje na podlagi podatkov, pridobljenih v pogodbenem laboratoriju, je neustrezno z vidika števila in resnosti pomanjkljivosti.
English: Revalidation of the testosterone method confirmed the confidence in the reliability of the results obtained earlier.
Slovenian: Ponovna validacija testosteronske metode je potrdila zaupanje v zanesljivost predhodno pridobljenih rezultatov.
English: It needs to be emphasized that the unique small (n=40) pharmacodynamic study performed by the sponsor is meant to substitute for a full clinical development.
Slovenian: Treba je poudariti, da je namen enolične majhne (n = 40) farmakodinamične študije, ki jo izvede sponzor, nadomestiti celoten klinični razvoj.
English: Data generated and reported in connection with these two studies had to be classified as not credible.
Slovenian: Podatki, ki so bili pridobljeni in o katerih so poročali v povezavi s tema dvema študijama, so bili označeni kot neverodostojni.
English: • testosterone levels below castration for both products.
Slovenian: • ravni testosterona pod kastracijo pri obeh zdravilih.
English: Overall, the value and reliability of a retrospective method-validation more than five years after end of GOS/001 and more than two years after end of GOS/002 is highly questionable.
Slovenian: V splošnem sta vrednost in zanesljivost retrospektivne validacije metode več kot pet let po zaključku GOS/001 in več kot dve leti po zaključku GOS/002 zelo sporni.
English: Considering the above, the CHMP is of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Slovenian: Ob upoštevanju zgoraj navedenega CHMP meni, da informacije, predložene v podporo vlogi, niso v skladu s členom 10 Direktive 2001/83/ES, kakor je bila spremenjena.
English: During the GCP inspection 19 findings were identified, of which 9 were classified as critical, 7 as major, and 3 as minor.
Slovenian: Po pregledu dobre klinične prakse so oblikovali 19 ugotovitev, od katerih je bilo 9 kritičnih, 7 pomembnih in 3 manj pomembne.
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormone-depending prostate carcinoma.
Slovenian: Je agonist LHRH (analog naravnega luteinizirajočega hormona za sproščanje hormonov) in zmanjša raven testosterona v serumu na raven kastracije, s čimer zavira rast hormonsko odvisnega raka prostate.
English: Goserelin is among others, authorised for patients with advanced prostate cancer where an endocrine treatment is indicated.
Slovenian: Goserelin je med drugim odobren za bolnike z napredovalim rakom prostate, pri katerih je indicirano endokrino zdravljenje.
English: The main objective of a method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific bioanalytical matrix and should appropriately be performed before analysis of study/subject samples.
Slovenian: Glavni cilj validacije metode je dokazati zanesljivost določene metode za določanje koncentracije analita v specifični bioanalitični matrici, kar je treba ustrezno izvajati pred analizo vzorcev študije/snovi.
English: These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Slovenian: Med te kršitve sodijo nezadostna validacija bioanalitičnih metod, brisanje surovih podatkov s ponovnim injiciranjem vzorcev, nedosledna ročna ponovna integracija kromatogramov, pomanjkanje bistvenih meril sprejemljivosti analiz ter nezadostno upravljanje kakovosti, ki ga opravi sponzor.
English: The Committee further considers that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health.
Slovenian: Odbor tudi meni, da na podlagi podatkov, predloženih v podporo tej vlogi, ni mogoče vzpostaviti pozitivnega razmerja med tveganji in koristmi za to zdravilo in da v tej okoliščinah trženje zdravila pomeni tveganje za javno zdravje.
English: The magnitude of deviation of results from actual serum concentration cannot be estimated.
Slovenian: Obsega odstopanja rezultatov od dejanske koncentracije v serumu ni mogoče oceniti.
English: Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Slovenian: Pomembni vidiki, kot so težave z endogenimi ravnmi testosterona v osnovni plazmi žensk, so bili obravnavani le v poročilu o retrospektivni validaciji z dodatnim preskušanjem na predhodno zdravljeni ali predhodno izbrani matrici.
English: Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Slovenian: Ker so bile izmerjene ravni testosterona pod mejo kvantifikacije ali blizu nje (0,1 ng/ml) in bistveno pod kastracijsko ravnjo 0,5 ng/ml, je klinična učinkovitost zagotovljena, tudi če analitična metoda ni dovolj natančna.
English: Overall summary of the scientific evaluation of Goserelin cell pharm 3,6 mg Implantat and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Goserelin cell pharm 3,6 mg Implantat in z njim povezanih imen (glejte Dodatek I)
English: It was the aim of the inspection to verify whether the clinical studies GOS/001/C and GOS/002/C were conducted in compliance with GCP and applicable regulations and whether the validity and quality of the submitted data are adequate.
Slovenian: Namen pregleda je bil preveriti, ali sta bili klinični študiji GOS/001/C in GOS/002/C izvedeni v skladu z dobro klinično prakso in veljavnimi predpisi ter ali sta veljavnost in kakovost predloženih podatkov ustrezni.
English: During the evaluation of the marketing authorisation application of some goserelin-containing medicinal products inconsistencies were recognised (e.g. assignment of patients to blood samples unclear).
Slovenian: Med vrednotenjem vloge za pridobitev dovoljenja za promet z nekaterimi zdravili, ki vsebujejo goserelin, so bile odkrite neskladnosti (npr. nejasna merila za razvrščanje bolnikov pri vzorčenju krvi).
English: The performance of a GCP-valid clinical and bioanalytical study is required to support application under such legal basis.
Slovenian: Izvedba klinične in bioanalitične študije v skladu z dobro klinično prakso je potrebna v podporo vlogi na takšni pravni podlagi.
English: • comparable AUC of testosterone after sufficient treatment days for MAH's product and comparator
Slovenian: • primerljiva vrednost AUC testosterona po zadostnem številu dni zdravljenja z zdravilom imetnika dovoljenja za promet z zdravilom in primerjalnim zdravilom;
English: • The Committee agreed that the bioanalytical studies submitted by the MAHs were not conducted in accordance with GCP as required by Annex I of Directive 2001/83/EC as amended and the nature of the findings is such that the conduct of the studies and their results cannot be relied on to maintain the marketing authorisation.
Slovenian: • Odbor se je strinjal, da bioanalitične študije, ki so jih predložili imetniki dovoljenja za promet z zdravilom, niso bile izvedene v skladu z dobro klinično prakso, kot določa Priloga I Direktive 2001/83/ES, kakor je bila spremenjena, ugotovitve pa so takšne, da se glede ohranitve dovoljenja za promet z zdravili ni mogoče zanesti na izvedbo študij in na njihove rezultate.
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Goserelin cell pharm 3,6 mg Implantat and associated names as listed in Annex I.
Slovenian: • Odbor je upošteval napotitveni postopek, sprožen v skladu s členom 36 Direktive 2001/83/ES, za zdravilo Goserelin cell pharm 3,6 mg Implantat in povezana imena, kot določa Priloga I.
English: The contract laboratory performed the analysis of the plasma samples for the clinical studies GOS/001/C and GOS/002/C.
Slovenian: V pogodbenem laboratoriju je bila izvedena analiza vzorcev plazme iz kliničnih študij GOS/001/C in GOS/002/C.
English: Scientific conclusions and grounds for suspension of the marketing authorisation(s) presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za začasni umik dovoljenj(a) za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
English: In view of the number and the seriousness of the deficiencies, the extent of deviations of the measured serum concentrations of both, goserelin and testosterone from the actual concentrations, cannot be estimated.
Slovenian: Glede na število in resnost pomanjkljivosti ni mogoče oceniti razsežnosti odstopanja izmerjenih koncentracij goserelina in testosterona v serumu od dejanskih koncentracij.
English: In view of all these facts the MAH requested the CHMP to confirm the acceptability of the existing clinical package for goserelin and maintain the marketing authorization for the concerned products.
Slovenian: Ob upoštevanju vseh teh dejstev je imetnik dovoljenja za promet z zdravilom pozval CHMP k potrditvi sprejemljivosti obstoječega kliničnega paketa za goserelin in k ohranitvi dovoljenja za promet z zadevnimi zdravili.
English: These inconsistencies led to a Good Clinical Practice (GCP) inspection of the contract laboratory by the German authority (BfArM).
Slovenian: Zaradi teh neskladnosti je nemški pristojni organ (BfArM) izvedel pregled dobre klinične prakse v pogodbenem laboratoriju.
English: Due to the observed critical and major findings in the studies GOS/001/C and GOS/002/C, a GCP compliant conduct could not be confirmed.
Slovenian: Zaradi opaženih kritičnih in pomembnih ugotovitev v študijah GOS/001/C in GOS/002/C skladnosti z dobro klinično prakso ni bilo mogoče potrditi.