FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: If pharmacodynamic/pharmacokinetic interactions exist between the substance and other medical products or substances like alcohol, caffeine, tobacco or nicotine, likely to be taken simultaneously, or if such interactions are likely, they should be described and discussed;
Slovenian: Če obstajajo farmakodinamične/farmakokinetične interakcije med snovjo in drugimi zdravili ali snovmi, kot so alkohol, kofein, tobak ali nikotin, ki se verjetno jemljejo hkrati, ali če je tako medsebojno učinkovanje možno, je to treba opisati in obravnavati;
English: particularly from the point of view of clinical relevance and the relationship to the statement concerning interactions in the summary of product characteristics presented in accordance with Article 11 point 5.6.
Slovenian: zlasti s stališča klinične ustreznosti in povezave s trditvijo o interakcijah v povzetku glavnih značilnosti zdravila, predloženem v skladu s točko 5.6 člena 11.
English: Bioavailability/bioequivalence
Slovenian: Biološka uporabnost/bioekvivalenca
English: The assessment of bioavailability must be undertaken in all cases where it is necessary, e.g. where the therapeutic dose is near the toxic dose or where the previous tests have revealed anomalies which may be related to pharmacodynamic properties, such as variable absorption.
Slovenian: Oceno biološke uporabnosti je treba opraviti v vseh primerih, kadar je to potrebno, npr. kadar je terapevtski odmerek blizu toksičnemu odmerku, ali kadar se v predhodnih preskusih odkrijejo nepravilnosti, ki se lahko povežejo s farmakodinamičnimi lastnostmi, kot je spremenljiva absorpcija.
English: In addition, an assessment of bioavailability shall be undertaken where necessary to demonstrate bioequivalence for the medicinal products referred to in Article 10(1)(a).
Slovenian: Prav tako se izvede ocena biološke uporabnosti, kadar je treba dokazati bioekvivalenco za zdravilo iz člena 10(1)(a).
English: In general, clinical trials shall be done as "controlled clinical trials" and if possible, randomized; any other design shall be justified.
Slovenian: Na splošno se klinična preskušanja izvajajo kot "kontrolirana klinična preskušanja" in če je mogoče, kot randomizirana, vsak drug načrt je treba utemeljiti.
English: The treatment of the control groups will vary from case to case and also will depend on ethical considerations;
Slovenian: Zdravljenje kontrolnih skupin se spreminja od skupine do skupine in je odvisno od etičnih vidikov;
English: thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo.
Slovenian: tako je v nekaterih primerih morda bolje primerjati učinkovitost novega zdravila z učinkovitostjo že uveljavljenega zdravila z dokazano terapevtsko vrednostjo kot pa z učinkom placeba.
English: As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps shall be taken to avoid bias, including methods of randomization and blinding.
Slovenian: Kolikor je mogoče, in zlasti pri preskušanjih, kjer učinka zdravila ni mogoče objektivno izmeriti, je treba v izogib pristranskosti ukrepati tako, da se vključijo metode naključnih in slepih vzorcev.
English: The protocol of the trial must include a thorough description of the statistical methods to be employed, the number and reasons for inclusion of patients (including calculations of the power of the trial), the level of significance to be used and a description of the statistical unit.
Slovenian: Protokol preskušanja mora vsebovati natančen opis statističnih metod, ki se bodo uporabljale, število bolnikov ter razloge za njihovo vključitev (upoštevajoč izračun moči preskusa), stopnjo značilnosti, ki se bo uporabljala, ter opis statistične enote.
English: Measures taken to avoid bias, particularly methods of randomization, shall be documented.
Slovenian: Dokumentirajo se ukrepi za preprečitev pristranskosti, zlasti metod naključnih vzorcev.
English: Inclusion of a large number of subjects in a trial must not be regarded as an adequate substitute for a properly controlled trial.
Slovenian: Vključitev velikega števila bolnikov v preskušanje se ne sme upoštevati kot primerno nadomestilo za ustrezno kontrolirano preskušanje.
English: Clinical statements concerning the efficacy or safety of a medicinal product under normal conditions of use which are not scientifically substantiated cannot be accepted as valid evidence.
Slovenian: Kliničnih izjav o učinkovitosti ali varnosti zdravila v predpisanih pogojih uporabe, ki znanstveno niso dovolj utemeljene, ni mogoče sprejeti kot veljaven dokaz.
English: The value of data on the efficacy and safety of a medicinal product under normal conditions of use will be very greatly enhanced if such data come from several competent investigators working independently.
Slovenian: Vrednost podatkov o učinkovitosti in varnosti zdravila v predpisanih pogojih uporabe se bo zelo povečala, če bodo podatki prihajali od več pristojnih raziskovalcev, ki delajo neodvisno.
English: For vaccines and serums, the immunological status and age of the trial population and the local epidemiology are of critical importance and shall be monitored during the trial and fully described.
Slovenian: Za cepiva in serume je odločilnega pomena imunološko stanje in starost skupine ljudi, udeleženih v preskušanju, ter lokalna epidemiologija, ki se med preskušanjem spremlja in v celoti opiše.
English: For live attenuated vaccines, clinical trials shall be so designed as to reveal potential transmission of the immunizing agent from vaccinated to non-vaccinated subjects.
Slovenian: Pri živih oslabljenih cepivih se klinično preskušanje načrtuje tako, da se razkrije morebiten prenos imunizirajoče učinkovine s cepljenih oseb na necepljene.
English: If transmission is possible, the genotypic and phenotypic stability of the immunizing agent shall be studied.
Slovenian: Če je prenos mogoč, se preuči stabilnost genotipa in fenotipa imunizirajoče učinkovine.
English: For vaccines and allergen products, follow-up studies shall include appropriate immunological tests, and where applicable, antibody assays.
Slovenian: Pri cepivih in alergenih nadaljnje študije vključujejo ustrezne imunološke preskuse, in kadar je to primerno, določanje vsebnosti protiteles.
English: The pertinence of the different trials to the assessment of safety and the validity of methods of evaluation shall be discussed in the expert report.
Slovenian: V strokovnem poročilu se obravnava primernost različnih preskušanj za oceno varnosti in veljavnosti metod vrednotenja.
English: All adverse events including abnormal laboratory values shall be presented individually and discussed, especially:
Slovenian: Vse neželene dogodke, vključno z nenormalnimi laboratorijskimi vrednostmi, se predstavi posebej in obravnava, zlasti:
English: in terms of overall adverse experience, and
Slovenian: v smislu celovitih neželenih izkušenj, ter
English: as a function of the nature, seriousness and causality of effects.
Slovenian: kot funkcijo vrste, resnosti in vzročnosti učinkov.
English: A critical assessment of relative safety, taking into account adverse reactions, shall be made in relation to:
Slovenian: Odločilno oceno relativne varnosti, ob upoštevanju neželenih učinkov, se izdela v zvezi z:
English: the disease to be treated,
Slovenian: boleznijo, ki se bo zdravila,
English: other therapeutic approaches,
Slovenian: drugimi terapevtskimi pristopi,
English: particular characteristics in sub-groups of patients,
Slovenian: posebnimi značilnostmi podskupin bolnikov,
English: preclinical data on toxicology and pharmacology.
Slovenian: predkliničnimi podatki o toksikologiji in farmakologiji.
English: Recommendations shall be made for the conditions of use, with the intention of reducing the incidence of adverse reactions.
Slovenian: Pripravijo se priporočila za pogoje uporabe, s ciljem, da se zmanjša pogostnost neželenih učinkov.
English: Documentation for applications in exceptional circumstances
Slovenian: Dokumentacija za vloge v izjemnih okoliščinah
English: When, in respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:
Slovenian: Če glede na posebne terapevtske indikacije vlagatelj lahko prikaže, da ne more predložiti obširnih podatkov o učinkovitosti in varnosti v predpisanih pogojih uporabe, ker:
English: the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or
Slovenian: se z indikacijami, za katere je zadevno zdravilo namenjeno, sooča tako redko, da se ne more smiselno pričakovati, da bo predložil obširne dokaze, ali
English: in the present state of scientific knowledge, comprehensive information cannot be provided, or
Slovenian: obsežnih informacij ni mogoče predložiti zaradi trenutnega stanja znanstvenih dognanj, ali
English: it would be contrary to generally accepted principles of medical ethics to collect such information,
Slovenian: bi bilo zbiranje tovrstnih informacij v nasprotju s splošno sprejetimi načeli medicinske etike,
English: marketing authorization may be granted on the following conditions:
Slovenian: se dovoljenje za promet z zdravilom lahko odobri pod naslednjimi pogoji:
English: the applicant completes on identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,
Slovenian: vlagatelj zaključi določen program raziskav v časovnem obdobju, ki ga določi pristojni organ, pridobljeni rezultati pa bodo podlaga za ponovno oceno razmerja koristi/tveganj;
English: the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and for a radiopharmaceutical, by an authorized person,
Slovenian: zadevno zdravilo se lahko izda le na zdravniški recept in se v določenih primerih lahko daje samo pod strogim zdravniškim nadzorom, po možnosti v bolnišnici ter v primeru radiofarmacevtskih izdelkov pod nadzorom pooblaščene osebe;
English: the package leaflet and any medical information shall draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
Slovenian: navodilo za uporabo in vse ostale medicinske informacije usmerijo zdravnikovo pozornost na dejstvo, da so razpoložljivi podatki o zadevnem zdravilu v določenih posebnih pogledih še vedno nezadostni.
English: Post-marketing experience
Slovenian: Post-marketinške izkušnje
English: If the medicinal product is already authorized in other countries, information shall be given in respect of adverse drug reactions of the medicinal product concerned and medicinal products containing the same active substance(s), in relation to the usage rates if possible.
Slovenian: Če je zdravilo že pridobilo dovoljenje za promet v drugih državah, se predložijo podatki o neželenih učinkih zadevnega zdravila ter zdravil, ki vsebujejo enako(e) zdravilno(e) učinkovino (e), po možnosti v povezavi s pogostnostjo uporabe.
English: Information from worldwide studies relevant to the safety of the medicinal product shall be included.
Slovenian: Vključijo se informacije raziskav iz celega sveta, ki so koristne za varnost zdravila.
English: For this purpose, an adverse drug reaction is a reaction which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.
Slovenian: V ta namen je neželen učinek zdravila učinek, ki je škodljiv in nenameren in se pojavlja pri odmerkih, ki se običajno dajejo ljudem za preventivo, diagnostiko ali terapijo bolezni ali za spremembo fiziološke funkcije.
English: In the case of vaccines already authorized in other countries, information on the monitoring of vaccinated subjects to evaluate the prevalence of the disease in question as compared to nonvaccinated subjects shall be submitted, when available.
Slovenian: Pri cepivih, ki so že pridobila dovoljenje za promet v drugih državah, se predložijo, če so na voljo, informacije o spremljanju cepljenih oseb, da se vrednoti razširjenost zadevne bolezni v primerjavi z osebami, ki niso bile cepljene.
English: For allergen products, response in periods of increased antigen exposure shall be identified.
Slovenian: Pri alergenih se določi odziv v časovnih obdobjih povečane izpostavljenosti antigenu.
English: For the purpose of demonstrating, pursuant to Article 10(1)(a)(ii), that the component(s) of a medicinal product have a well established use, with recognised efficacy, the following specific rules shall apply:
Slovenian: Da se na podlagi člena 10(1)(a)(ii) dokaže, da ima(jo) sestavina(e) zdravila že dobro uveljavljeno uporabo s priznanimi učinki, se uporabljajo naslednja posebna pravila:
English: Factors which have to be taken into account in order to establish a "well established medicinal use" of components of medicinal products are the time over which a substance has been used, quantitative aspects of the use of the substance, the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and the coherence of scientific assessments.
Slovenian: Dejavniki, ki jih je treba upoštevati za določitev "dobro uveljavljene medicinske uporabe" sestavin zdravil so: čas uporabe snovi, količinski vidiki uporabe snovi, stopnja znanstvenega zanimanja za uporabo snovi (kar se odraža v objavljeni znanstveni literaturi) ter skladnost znanstvenih ocen.
English: Therefore different periods of time may be necessary for establishing "well established use" of different substances.
Slovenian: Za ugotavljanje "dobro uveljavljene uporabe" različnih snovi bodo morda zato potrebna različna časovna obdobja.
English: In any case, however, the period of time required for establishing a "well established medicinal use" of a component of a medicinal product must not be less than one decade from the first systematic and documented use of that substance as a medicinal product in the Community.
Slovenian: V vsakem primeru pa časovno obdobje za ugotavljanje "dobro uveljavljene medicinske uporabe" sestavine zdravila ne sme biti krajše od enega desetletja od prve sistematične in dokumentirane uporabe snovi kot zdravila v Skupnosti.
English: The documentation submitted by the applicant should cover all aspects of the efficacy assessment and must include or refer to a review of the relevant literature, taking into account pre- and postmarketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies.
Slovenian: Dokumentacija, ki jo vlagatelj predloži, mora zajemati vse vidike ocene učinkovitosti ter mora vključevati, ali se sklicevati na pregled ustrezne literature, ob upoštevanju pre- in post-marketinških raziskav ter objavljene znanstvene literature o izkušnjah v obliki epidemioloških študij in zlasti primerjalnih epidemioloških študij.
English: Particular attention must be paid to any missing information and justification must be given why demonstration of efficacy can be supported although some studies are lacking.
Slovenian: Posebno pozornost je treba posvetiti morebitnim manjkajočim informacijam ter obvezno podati utemeljitev, zakaj prikaz učinkovitosti zadostuje, čeprav nekatere študije manjkajo.
English: The Expert report must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Slovenian: V strokovnem poročilu je treba obrazložiti pomembnost vseh predloženih podatkov o zdravilu, ki se razlikuje od zdravila, namenjenega za trženje.
English: A judgment must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorisation in spite of the existing differences.
Slovenian: Presoditi je treba, ali se zdravilo v preskušanju lahko šteje kot podobno zdravilu, za katerega bo izdano dovoljenje za promet z zdravilom, kljub obstoječim razlikam.
English: Post-marketing experience with other products containing the same components is of particular importance and applicants should put a special emphasis on this issue.
Slovenian: Post-marketinške izkušnje z drugimi zdravili, ki vsebujejo enake sestavine, so posebnega pomena, zato morajo vlagatelji temu posvetiti posebno pozornost.
English: The competent authorities may also request the pK and pH values if they think this information is essential.
Slovenian: Pristojni organi lahko zahtevajo vrednosti pK in pH, če menijo, da je informacija bistvena.
English: Repealed Directives, with their successive amendments (referred to by Article 128)
Slovenian: Razveljavljene direktive z njihovimi zaporednimi spremembami (na katere se sklicuje člen 128)
English: Council Directive 65/65/EEC (OJ 22, 9.2.1965, p. 369/65)
Slovenian: Direktiva Sveta 65/65/EGS (UL 22, 9.2.1965, str. 369/65)
English: Council Directive 66/454/EEC (OJ 144, 5.8.1966, p. 2658/66)
Slovenian: Direktiva Sveta 66/454/EGS (UL 144, 5.8.1966, str. 2658/66)
English: Council Directive 75/319/EEC (OJ L 147, 9.6.1975, p. 13)
Slovenian: Direktiva Sveta 75/319/EGS (UL L 147, 9.6.1975, str. 13)
English: Council Directive 83/570/EEC (OJ L 332, 28.11.1983, p. 1)
Slovenian: Direktiva Sveta 83/570/EGS (UL L 332, 28.11.1983, str. 1)
English: Council Directive 87/21/EEC (OJ L 15, 17.1.1987, p. 36)
Slovenian: Direktiva Sveta 87/21/EGS (UL L 15, 17.1.1987, str. 36)
English: Council Directive 89/341/EEC (OJ L 142, 25.5.1989, p. 11)
Slovenian: Direktiva Sveta 89/341/EGS (UL L 142, 25.5.1989, str. 11)
English: Council Directive 92/27/EEC (OJ L 113, 30.4.1992, p. 8)
Slovenian: Direktiva Sveta 92/27/EGS (UL L 113, 30.4.1992, str. 8)
English: Council Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22)
Slovenian: Direktiva Sveta 93/39/EGS (UL L 214, 24.8.1993, str. 22)
English: Council Directive 75/318/EEC (OJ L 147, 9.6.1975, p. 1)
Slovenian: Direktiva Sveta 75/318/EGS (UL L 147, 9.6.1975, str. 1)
English: Council Directive 83/570/EEC
Slovenian: Direktiva Sveta 83/570/EGS
English: Council Directive 87/19/EEC (OJ L 15, 17.1.1987, p. 31)
Slovenian: Direktiva Sveta 87/19/EGS (UL L 15, 17.1.1987, str. 31)
English: Council Directive 89/341/EEC
Slovenian: Direktiva Sveta 89/341/EGS
English: Commission Directive 91/507/EEC (OJ L 270, 26.9.1991, p. 32)
Slovenian: Direktiva Komisije 91/507/EGS (UL L 270, 26.9.1991, str. 32)
English: Council Directive 93/39/EEC
Slovenian: Direktiva Sveta 93/39/EGS
English: Commission Directive 1999/82/EC (OJ L 243, 15.9.1999, p. 7)
Slovenian: Direktiva Komisije 1999/82/ES (UL L 243, 15.9.1999, str. 7)
English: Commission Directive 1999/83/EC (OJ L 243, 15.9.1999, p. 9)
Slovenian: Direktiva Komisije 1999/83/ES (UL L 243, 15.9.1999, str. 9)
English: Council Directive 75/319/EEC
Slovenian: Direktiva Sveta 75/319/EGS
English: Council Directive 78/420/EEC (OJ L 123, 11.5.1978, p. 26)
Slovenian: Direktiva Sveta 78/420/EGS (UL L 123, 11.5.1978, str. 26)
English: Council Directive 92/27/EEC
Slovenian: Direktiva Sveta 92/27/EGS
English: Commission Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28)
Slovenian: Direktiva Komisije 2000/38/ES (UL L 139, 10.6.2000, str. 28)
English: Council Directive 89/342/EEC (OJ L 142, 25.5.1989, p. 14)
Slovenian: Direktiva Sveta 89/342/EGS (UL L 142, 25.5.1989, str. 14)
English: Council Directive 89/343/EEC (OJ L 142, 25.5.1989, p. 16)
Slovenian: Direktiva Sveta 89/343/EGS (UL L 142, 25.5.1989, str. 16)
English: Council Directive 89/381/EEC (OJ L 181, 28.6.1989, p. 44)
Slovenian: Direktiva Sveta 89/381/EGS (UL L 181, 28.6.1989, str. 44)
English: Council Directive 92/25/EEC (OJ L 113, 30.4.1992, p. 1)
Slovenian: Direktiva Sveta 92/25/EGS (UL L 113, 30.4.1992, str. 1)
English: Council Directive 92/26/EEC (OJ L 113, 30.4.1992, p. 5)
Slovenian: Direktiva Sveta 92/26/EGS (UL L 113, 30.4.1992, str. 5)
English: Council Directive 92/28/EEC (OJ L 113, 30.4.1992, p. 13)
Slovenian: Direktiva Sveta 92/28/EGS (UL L 113, 30.4.1992, str. 13)
English: Council Directive 92/73/EEC (OJ L 297, 13.10.1992, p. 8)
Slovenian: Direktiva Sveta 92/73/EGS (UL L 297, 13.10.1992, str. 8)
English: Time-limits for transposition into national law (referred to by Article 128)
Slovenian: Roki za prenos v nacionalno zakonodajo (kot navedeno v členu 128)
English: Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3),
French: La directive 65/65/CEE du Conseil du 26 janvier 1965 concernant le rapprochement des dispositions législatives, réglementaires et administratives, relatives aux médicaments(3),
Danish: Rådets direktiv 65/65/EØF af 26. januar 1965 om tilnærmelse af lovgivning om medicinske specialiteter(3),
Polish: Dyrektywa Rady 65/65/EWG z dnia 26 stycznia 1965 r. w sprawie zbliżenia przepisów ustawowych, wykonawczych lub działań administracyjnych odnoszących się do leków gotowych[3],
Slovenian: Direktiva Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov o lastniških zdravilih [3],
Latvian: Padomes 1965. gada 26. janvāra Direktīva 65/65/EEK par to normatīvo vai administratīvo aktu noteikumu tuvināšanu, kas attiecas uz zālēm [3],
Lithuanian: 1965 m. sausio 26 d. Tarybos direktyva 65/65/EEB dėl įstatymų ir kitų teisės aktų, susijusių su vaistais, nuostatų suderinimo[3],
English: have been frequently and substantially amended. In the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text.
Lithuanian: buvo dažnai ir iš esmės keičiamos, todėl, siekiant aiškumo bei racionalumo, minėtos direktyvos turi būti susistemintos, sujungiant jas į vieną tekstą.
English: Such hindrances must accordingly be removed;
French: Il importe par suite d'éliminer ces entraves
German: Diese Hindernisse müssen folglich beseitigt werden;
Portuguese: Importa, por conseguinte, eliminar estes entraves.
Finnish: On tärkeää poistaa tämän vuoksi nämä esteet;
Czech: Takové překážky musí být proto odstraněny;
Slovak: Tieto prekážky sa musia preto odstrániť;
Polish: Takie przeszkody muszą zostać, odpowiednio, usunięte;
Hungarian: Ezért az ilyen akadályokat meg kell szüntetni;
Slovenian: Ovire je zato treba odpraviti;
Bulgarian: Такива пречки трябва съответно да бъдат отстранени;
Estonian: Seetõttu tuleb nimetatud takistused kõrvaldada;
Latvian: Minētie šķēršļi ir attiecīgi jānovērš;
Lithuanian: Taigi šios kliūtys turi būti pašalintos;
Maltese: Ostakoli bħal dawn għandhom għalhekk jitneħħew;