FrancophonIA/ELRC3.0 huggingface dataset:
English: Three out of the nineteen adverse events did not require any medical intervention.
Slovenian: Pri treh izmed devetnajstih neželenih učinkov ni bil potreben zdravniški poseg.
English: The manufacturing process has been successfully validated with three batches.
Slovenian: Proizvodni postopek je bil uspešno potrjen s tremi serijami.
English: The Applicant defended the objection that not all possible salts had been considered.
Slovenian: Predlagatelj je ugovarjal, da niso bile proučene vse možne soli.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL ORION
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CLOPIDOGREL ORION
English: In the bioequivalence study, a total of 19 adverse events were reported by 13 subjects.
Slovenian: V študiji biološke enakovrednosti se je poročalo o skupaj 19 neželenih učinkih pri 13 osebkih.
English: Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product.
Slovenian: Izmed 19 opaženih neželenih učinkov jih je 14 nastalo zaradi referenčnega zdravila in 5 zaradi zdravila v preskušanju.
English: - Quality issues
Slovenian: - Vprašanja glede kakovosti
English: Furthermore the objecting CHMP members pointed out that in both guidelines, it is also stated that antioxidants should not be used to disguise poorly formulated products.
Slovenian: Poleg tega so nasprotujoči člani Odbora poudarili, da je v obeh smernicah navedeno tudi, da se antioksidanti ne smejo uporabljati za prikrivanje slabo formuliranih zdravil.
English: It was argued by the objecting CHMP members that according to the Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product (EMEA/CHMP/QWP/396951/2006) and the Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products (CPMP/CVMP/QWP/115/95), the use of antioxidants should be avoided whenever possible.
Slovenian: Nasprotujoči člani Odbora za zdravila za uporabo v humani medicini so trdili, da se je treba v skladu s Smernicami o pomožnih snoveh v dokumentaciji za vlogo za pridobitev dovoljenja za promet z zdravilom (EMEA/CHMP/QWP/396951/2006) in Navodilom za smernico o vključitvi antioksidantov in protimikrobnih konzervansov v zdravila (CPMP/CVMP/QWP/115/95) uporabi antioksidantov izogniti, kadar je to mogoče.
English: Strength Pharmaceutical Form Route of administration
Slovenian: Farmacevtska oblika Pot uporabe
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, VLAGATELJEV V DRŽAVAH ČLANICAH
English: BHA is present in amounts less than the ADI, which is generally deduced from the No Effect Level of the substance; therefore a biological action or effect on the patients is not expected.
Slovenian: BHA je vsebovana v količinah, ki so manjše od sprejemljivega dnevnega vnosa, ki je običajno izpeljan iz ravni brez učinka snovi; zato se ne pričakuje biološko delovanje ali učinek na bolnike.
English: The drug substance and the drug product manufacturer have been shown to be capable of producing a, stable product essentially similar in efficacy and safety to the reference product.
Slovenian: Pokazalo se je, da je proizvajalec snovi zdravila in proizvoda zmožen izdelati stabilno zdravilo, ki je glede učinkovitosti in varnosti v osnovi podobno referenčnemu zdravilu.
English: are stable in comparison to clopidogrel bisulphate, which is sensitive to hydrolytic degradation.
Slovenian: so stabilne v primerjavi s klopidogrel bisulfatom, ki je občutljiv na hidolizno razgradnjo;
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Slovenian: Odbor za zdravila za uporabo v humani medicini je proučil dokumentacijo in razpoložljive podatke, vključno z vprašanji, ki so jih izpostavile nasprotujoče zadevne države članice.
English: Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Slovenian: Ker 60. dan ni bilo doseženo soglasje, je bila zadeva predložena Odboru za zdravila za uporabo v humani medicini (CHMP).
English: In addition, the CHMP was also concerned that it had not been demonstrated that the proposed production and quality control methods could guarantee that a major deficiency in the quality of the product would not occur.
Slovenian: Odbor za zdravila za uporabo v humani medicini je izrazil tudi zaskrbljenost, da ni bilo dokazano, da bi predlagani načini proizvodnje in nadzora kakovosti lahko zagotovili, da ne pride do velike pomanjkljivosti v kakovosti zdravila.
English: It was argued that at that time, the potential to develop a salt with suitable pharmaceutical and pharmacological properties, and free from any FTO (freedom-to-operate) issues later, was thoroughly literature researched.
Slovenian: Trdil je, da je bila možnost razvoja soli z ustreznimi farmacevtskimi in farmakološkimi lastnostmi ter brez kasnejših vprašanj svobode upravljanja natančno raziskana na podlagi literature.
English: Clopidogrel is indicated for the prevention of atherothrombotic events in patients suffering from myocardial infarction or acute coronary syndrome.
Slovenian: Klopidogrel je indiciran za preprečevanje aterotrombotičnih dogodkov pri bolnikih z miokardnim infarktom ali akutnim koronarnim sindromom.
English: - in the view of the CHMP, do not differ with regard to safety relevant properties.
Slovenian: - se po mnenju Odbora za zdravila za uporabo v humani medicini ne razlikujejo glede pomembnih varnostnih značilnosti.
English: The Applicant also claimed that the test product when compared with the reference product Plavix, met the bioequivalence criteria with respect to the rate and extent of absorption of clopidogrel.
Slovenian: Predlagatelj je trdil tudi, da zdravilo v preskušanju v primerjavi z referenčnim zdravilom Plavix izpolnjuje merila biološke enakovrednosti v zvezi s stopnjo in obsegom absorpcije klopidogrela.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so dokončne različice, dosežene v postopku koordinacijske skupine.
English: Although the clopidogrel free base posed the challenges of converting an unstable, gummy and sticky nature into a granular, free flowing and stable material for use in formulations, the Applicant chose the clopidogrel free base as the suitable candidate for product development.
Slovenian: Čeprav je prosta klopidogrelova baza predstavljala izziv zaradi spremembe nestabilnega, gumijastega in lepljivega materiala v zrnast, prosto tekoč in stabilen material za uporabo v formulacijah, je predlagatelj prosto klopidogrelovo bazo izbral za primernega kandidata za razvoj zdravila.
English: The CHMP noted that the primary purpose for the addition of BHA was to prevent the initiation of free radicals, by blocking the oxidative pathway, and was assured by the Applicant that the lowest level possible had been used.
Slovenian: Odbor za zdravila za uporabo v humani medicini je izpostavil, da je bil prvotni namen dodajanja BHA preprečevanje nastajanja prostih radikalov z zaviranjem oksidativne poti in da je predlagatelj zagotovil, da je bila uporabljena najnižja možna raven.
English: The Applicant addressed the long-term safety of BHA at the oral explanation before the CHMP on 17 February 2010, by making reference to the Acceptable Daily Intake (ADI), an estimate of the amount of BHA that can be ingested on a daily basis over a lifetime without appreciable risk to health.
Slovenian: Predlagatelj je na ustni obrazložitvi pred Odborom za zdravila za uporabo v humani medicini dne 17. februarja 2010 izpostavil dolgoročno varnost BHA s sklicevanjem na sprejemljiv dnevni vnos, tj. oceno količine BHA, ki se lahko zaužije dnevno v življenjski dobi brez znatnega tveganja za zdravje.
English: The chosen clopidogrel base necessitated the use of an antioxidant which was not considered to be optimal.
Slovenian: Izbrana klopidogrelova baza je zahtevala uporabo antioksidanta, za katerega se meni, da ni optimalen.
English: The Clopidogrel Orion 75 mg Film coated Tablets:
Slovenian: Clopidogrel Orion 75 mg filmsko obložene tablete:
English: The adenylate cyclase-coupled ADP receptor P2Y12 is the main target of clopidogrel and leads to inhibition of platelet activation, aggregation, and Gp IIb/IIIa receptor activation.
Slovenian: Glavna tarča klopidogrela je receptor ADP P2Y12 adenilatne ciklaze ter zavira aktivacijo in agregacijo trombocitov ter aktivacijo receptorjev Gp IIb/IIIa.
English: When clopidogrel bisulfate (as in Reference product) and clopidogrel base (as in Test product) were administered as a single dose to healthy volunteers in this study, the drug products were well tolerated with no serious adverse events for either, and no relevant difference in the safety profiles of the test and reference formulation was observed with regard to the number and pattern of adverse events.
Slovenian: Ko sta bila zdravim prostovoljcem v tej študiji dana klopidogrel bisulfat (v referenčnem zdravilu) in klopidogrelova baza (v zdravilu v preskušanju) v enkratnem odmerku, so ti zdravili dobro prenašali brez resnih neželenih učinkov pri obeh, opažena pa ni bila nobena pomembna razlika v varnostnem profilu testne in referenčne formulacije glede števila in vzorca neželenih učinkov.
English: This was not considered to be acceptable by the objecting Concerned Member State (CMS) as there are stable salts available, and the use of the clopidogrel base was considered to result in an unnecessary exposure of patients to an antioxidant.
Slovenian: Zadevne države članice so temu nasprotovale, saj se jim to ni zdelo sprejemljivo, ker so na voljo stabilne soli, ter so menile, da je posledica uporabe klopidogrelove baze nepotrebna izpostavljenost bolnikov antioksidantu.
English: It is also argued that in view of the above, the selection of the clopidogrel base and the development of the clopidogrel premix had been justified for its use in generic formulation.
Slovenian: Trdi tudi, da sta bila glede na zgoraj navedeno izbira klopidogrelove baze in razvoj klopidogrelovega premiksa utemeljena za uporabo v generični formulaciji.
English: The Applicant attended the CHMP meeting for an oral explanation on 17 February 2010 to present their position with regard to the choice of clopidogrel base as the active substance compared to the more stable clopidogrel salts, and also to discuss the safety of the long-term use of BHA.
Slovenian: Predlagatelj se je udeležil sestanka Odbora za zdravila za uporabo v humani medicini dne 17. februarja 2010, da bi ustno pojasnil svoja stališča glede izbire klopidogrelove baze kot zdravilne učinkovine v primerjavi s stabilnejšimi klopidogrelovimi solmi in tudi razpravljal o varnosti dolgoročne uporabe BHA.
English: The Applicant explained that to make it feasible for better handling, it was decided to add the excipient BHA, which in turn resulted in a stable clopidogrel premix.
Slovenian: Predlagatelj je pojasnil, da je bilo, da bi omogočili boljše ravnanje, odločeno, da se doda pomožno snov BHA, kar je dalo stabilen klopidogrelov premiks.
English: Since the nature of the base made it unsuitable to incorporate appropriate in-process quality checks for the clopidogrel base, the Applicant has attempted to control the quality of the base produced by ensuring the quality of the intermediate.
Slovenian: Ker zaradi narave baze ni primerno vključiti ustreznih pregledov kakovosti med proizvodnjo za klopidogrelovo bazo, je predlagatelj poskušal nadzorovati kakovost proizvedene baze z zagotavljanjem kakovosti vmesnih produktov.
English: In order to circumvene the challenges of using the clopidogrel base, it was essential to convert it into a granular and free flowable material.
Slovenian: Da bi premagali izzive uporabe klopidogrelove baze, je bilo bistvenega pomena bazo spremeniti v zrnast in sipek material.
English: Based on the information presented, taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts of clopidogrel were found to be unsuitable for product development for various reasons.
Slovenian: Na podlagi predloženih informacij je bilo ugotovljeno, da so tavroholatna, hidrokloridna, hidrobromidna in hidrogensulfatna soli klopidogrela iz različnih razlogov neprimerne za razvoj zdravila.
English: Clopidogrel is a non-competitive inhibitor of adenosine diphosphate (ADP) at the platelet receptors.
Slovenian: Klopidogrel je nekompetitivni zaviralec adenozin difosfata (ADP) na trombocitnih receptorjih.
English: are bioequivalent to the reference medicinal product clopidogrel bisulphate
Slovenian: so biološko enakovredne referenčnemu zdravilu klopidogrel bisulfat;
English: However in view of the fact that no major concerns were found in relation to quality of the product and that the use of antioxidant did not pose a safety concern, the CHMP accepted the choice of the clopidogrel base.
Slovenian: Vendar pa je Odbor za zdravila za uporabo v humani medicini glede na dejstvo, da niso bili najdeni pomembni pomisleki v zvezi s kakovostjo zdravila in da uporaba antioksidanta ne predstavlja težav z varnostjo, sprejel izbiro klopidogrelove baze.
English: Taking into consideration the literature survey, the taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts and free base of clopidogrel were considered.
Slovenian: Ob upoštevanju pregleda literature so bile proučene tavroholatna, hidrokloridna, hidrobromidna in hidrogensulfatna sol ter prosta klopidogrelova baza.
English: The Applicant explained that the amount of BHA from clopidogrel tablets was no more than 0.75% of its ADI, which was argued to be a negligible.
Slovenian: Pojasnil je tudi, da količina BHA iz tablet klopidogrela ne znaša več kot 0,75 % sprejemljivega dnevnega vnosa, kar naj bi bilo zanemarljivo.
English: In contrast to the reference product that contains the hydrogen sulphate salt, the generic product contains a clopidogrel base.
Slovenian: V nasprotju z referenčnim zdravilom, ki vsebuje hidrogensulfatno sol, vsebuje generično zdravilo klopidogrelovo bazo.
English: Overall, it is claimed by the Applicant that their clopidogrel tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product.
Slovenian: Na splošno predlagatelj trdi, da so njegove 75-miligramske tablete kolpidogrela ustrezne kakovosti, imajo ustrezno razmerje med koristmi in tveganji ter so primerljive z referenčnim zdravilom.
English: Therefore the chosen antioxidant BHA and the concentration in which it is used, was considered to be acceptable by the CHMP, from a safety point of view.
Slovenian: Zato je Odbor za zdravila za uporabo v humani medicini izbrani antioksidant in koncentracijo, v kateri se je uporabljal, štel za sprejemljiva z vidika varnosti.
English: As the clopidogrel base corresponds to an unstable, viscous mass, the drug substance is stabilized by means of a premix, which contains the antioxidant butylated hydroxy anisol (BHA).
Slovenian: Ker je klopidogrelova baza nestabilna, viskozna masa, se snov zdravila stabilizira s premiksom, ki vsebuje antioksidant butilhidroksi anizol (BHA).
English: The use of the unstable clopidogrel base as active substance necessitated the use of the antioxidant butylated hydroxyl anisol (BHA) for stabilisation.
Slovenian: Zaradi uporabe nestabilne klopidogrelove baze kot zdravilne učinkovine je bila za stabilizacijo potrebna uporaba antioksidanta butilhidroksi anizola (BHA).
English: - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained
Slovenian: - predlagateljeva izbira klopidogrelove baze in posledična uporaba BHA sta bili zadovoljivo obrazloženi;
English: The product is formulated as immediate release tablets containing 75 mg clopidogrel.
Slovenian: Zdravilo je izdelano v obliki tablet s takojšnjim sproščanjem, ki vsebujejo 75 mg klopidogrela.
English: From the data provided the Applicant claimed that clopidogrel tablets 75 mg are stable when compared to Plavix 75 mg (Clopidogrel Bisulphate Tablets 75 mg).
Slovenian: Na podlagi predloženih podatkov je predlagatelj zatrjeval, da so 75-miligramske tablete klopidogrela stabilne v primerjavi z zdravilom Plavix 75 mg (75-miligramske tablete klopidogrel bisulfata).
English: Clopidogrel is known to hydrolyse and to form a hydrolytic impurity i.e an acetic acid impurity, which is a major degradant.
Slovenian: Znano je, da klopidogrel hidrolizira in oblikuje hidrolitično nečistoto, tj. nečistoto ocetne kisline, ki je glavni razgradni produkt.
English: - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base
Slovenian: - splošna strategija nadzora za zagotovitev ustrezne in ponovljive kakovosti zdravila je bila utemeljena glede ravnanja z viskozno snovjo klopidogrelove baze;
English: In conclusion, the CHMP agreed that although the choice of the clopidogrel base was not considered to be optimal, the use of BHA and the production process did not pose a potentially serious risk to public health.
Slovenian: Na koncu se je Odbor strinjal, da uporaba BHA in proizvodni postopek ne predstavljata možnega resnega tveganja za javno zdravje, čeprav izbira klopidogrelove baze ni bila optimalna.
English: The reference medicinal product for this generic application is Plavix (Clopidogrel Hydrogen sulphate) 75 mg film-coated tablets.
Slovenian: Referenčno zdravilo za to generično vlogo je Plavix (klopidogrel hidrogensulfat) v obliki 75-miligramskih filmsko obloženih tablet.
English: The premix approach was thought to help in the flow property of clopidogrel base.
Slovenian: Menilo se je, da bo premiks pripomogel k sipkosti klopidogrelove baze.
English: The CHMP agreed that the Applicant's choice of the clopidogrel base and consequently the use of BHA had been sufficiently explained.
Slovenian: Odbor za zdravila za uporabo v humani medicini se je strinjal, sta bili predlagateljeva izbira klopidogrelove baze in posledična uporaba BHA zadovoljivo obrazloženi.
English: Therefore justification that the overall control strategy ensured suitable and reproducible quality of the product with regard to the handling of the viscous mass of clopidogrel base was requested from the Applicant and justification also for the absence of specifications for the clopidogrel base.
Slovenian: Zato je bila od predlagatelja zahtevana utemeljitev, da splošna strategija nadzora zagotavlja ustrezno in ponovljivo kakovost zdravila v zvezi z ravnanjem z viskozno snovjo klopidogrelove baze, in tudi utemeljitev glede odsotnosti specifikacij za klopidogrelovo bazo.
English: The acetic acid impurity (a major degradant) was found to be controlled in the Applicant's clopidogrel Tablets 75 mg as compared to Plavix 75 mg (Clopidogrel Bisulphate Tablet 75 mg).
Slovenian: Ugotovljeno je bilo tudi, da je nečistota ocetne kisline (glavni razgradni produkt), nadzorovana v predlagateljevih 75-miligramskih tabletah klopidogrela v primerjavi z zdravilom Plavix 75 mg (75-miligramska tableta klopidogrel bisulfata).
English: The product developed with clopidogrel premix was found to be non-hygroscopic.
Slovenian: Ugotovljeno je bilo, da je zdravilo, razvito s premiksom klopidogrela, nehigroskopsko.
English: The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Slovenian: Zadeva je bila napotena za proučitev skupini za usklajevanje postopka z medsebojnim priznavanjem in decentraliziranega postopka za zdravila za uporabo v humani medicini, CMD(h), referenčne države članice pa so izvedle oceno.
English: The overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base, and the proposed specifications for the clopidogrel base are considered to be acceptable by the CHMP.
Slovenian: Splošna strategija nadzora zagotavlja ustrezno in ponovljivo kakovost zdravila v zvezi z ravnanjem z viskozno snovjo klopidogrelove baze, Odbor za zdravila za uporabo v humani medicini pa meni tudi, da so predložene specifikacije za klopidogrelovo bazo sprejemljive.
English: - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product 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 procedure as mentioned in Annex III of this Opinion.
Slovenian: je Odbor za zdravila za uporabo v humani medicini priporočil odobritev dovoljenja za promet z zdravilom, za katerega ostajajo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v obliki zadnjih različic, dogovorjenih v postopku skupine za usklajevanje, kot je navedeno v Dodatku III tega mnenja.
English: ENGLISH
Slovenian: SLOVENIAN
English: STORING X
Slovenian: SHRANJEVANJE ZDRAVILA X
English: <This medicine does not require any special temperature storage conditions>*****
Slovenian: <Za shranjevanje zdravila ni posebnih temperaturnih omejitev.>*****
English: <Store in a refrigerator (2(C - 8(C)
Slovenian: <Shranjujte v hladilniku (2 °C - 8 °C).>
English: <This medicine does not require any special storage conditions>
Slovenian: <Za shranjevanje zdravila niso potrebna posebna navodila.>
English: <Store in a refrigerator>
Slovenian: <Shranjujte v hladilniku.>
English: <Store and transport refrigerated (2(C - 8(C)>*
Slovenian: <Zdravilo shranjujte in prevažajte na hladnem (2 °C - 8 °C).>*
English: <Store and transport frozen {temperature range}>**
Slovenian: <Zdravilo shranjujte in prevažajte zamrznjeno {temperaturno območje}.>**
English: <Store in a freezer {temperature range}>
Slovenian: <Shranjujte v zamrzovalniku {temperaturno območje}.>
English: <Store and transport frozen>**
Slovenian: <Zdravilo shranjujte in prevažajte zamrznjeno.>**
English: <Store in a freezer>
Slovenian: <Shranjujte v zamrzovalniku.>
English: ATC-vet code: QI01AA23.
Slovenian: Oznaka ATC vet: QI01AA23.
English: Special warning for the user:
Slovenian: Posebno opozorilo, namenjeno uporabniku:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
English: Use sterile syringes and needles.
Slovenian: Uporabite sterilne brizge in igle.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtu trženja zdravila, odobrenega za promet s to odločbo.
English: This product contains mineral oil.
Slovenian: Zdravilo vsebuje mineralno olje.
English: Efficacy has been evaluated on the basis of preliminary results in chickens.
Slovenian: Učinkovitost so ocenjevali na podlagi preliminarnih rezultatov pri piščancih.
English: MARKETING AUTHORISATION NUMBER EU/2/06/061/001-004
Slovenian: EU/2/06/061/001-004
English: Glass vials: 1 year.
Slovenian: Steklene viale: 1 leto
English: One dose of 0.5 ml contains:
Slovenian: En odmerek po 0,5 ml vsebuje:
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Slovenian: Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena le v določenih razmerah, opredeljenih v zakonodaji Evropske skupnosti o nadzoru nad aviarno influenco.
English: It is recommended to use a closed multiject vaccination system.
Slovenian: Priporočamo uporabo zaprtega sistema za cepljenje z večtočkovnim vbrizgom.