FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;
Slovenian: učinkovine, ki se uporabljajo za diagnosticiranje stanja imunosti, vključno zlasti s tuberkulinom in tuberkulinom PPD, toksini za Schickov in Dickov test, brucelin;
English: agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;
Slovenian: učinkovine, ki so sposobne izzvati pasivno imunost, kot npr. antitoksin za davico, globulin proti črnim kozam, antilimfocitni globulin;
English: "allergen product" shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
Slovenian: "alergen" je vsako zdravilo, ki je namenjeno za določitev ali sproženje specifične pridobljene spremembe v imunološkem odzivu na alergen.
English: Homeopathic medicinal product:
Slovenian: Homeopatska zdravila :
English: Any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States.
Slovenian: Vsako zdravilo, pripravljeno iz izdelkov, snovi ali sestavin, ki se imenujejo homeopatske surovine, v skladu s homeopatskim postopkom izdelave po določilih Evropske farmakopeje, ali v odsotnosti tega, po drugih farmakopejah, ki se uradno uporabljajo v državah članicah.
English: A homeopathic medicinal product may also contain a number of principles.
Slovenian: Homeopatsko zdravilo lahko vsebuje tudi več učinkovin.
English: Radiopharmaceutical:
Slovenian: Radiofarmacevtski izdelek :
English: Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose.
Slovenian: Vsak izdelek, ki vsebuje, takrat ko je pripravljen za uporabo, enega ali več radionuklidov (radioaktivnih izotopov), namenjenih medicinski uporabi.
English: Radionuclide generator:
Slovenian: Radionuklidni generator :
English: Any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical.
Slovenian: Vsak sistem z vgrajenim trdo vezanim starševskim radionuklidom, iz katerega nastane hčerinski radionuklid, ki se pridobiva z eluiranjem ali drugo metodo in se uporablja v radiofarmacevtskem izdelku.
English: Radionuclide kit:
Slovenian: Radionuklidni komplet :
English: Any preparation to be reconsitituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration.
Slovenian: Vsak pripravek, ki ga rekonstituiramo ali kombiniramo z radionuklidi v končnem radiofarmacevtskem izdelku, običajno pred dajanjem bolniku.
English: Radionuclide precursor:
Slovenian: Radionuklidni predhodnik :
English: Any other radionuclide produced for the radio-labelling of another substance prior to administration.
Slovenian: Vsak drug radionuklid, pripravljen za označevanje sevanja druge snovi pred dajanjem bolniku.
English: Medicinal products derived from human blood or human plasma:
Slovenian: Zdravila, izdelana iz človeške krvi ali človeške plazme :
English: Medicinal products based on blood constitutents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.
Slovenian: Vsa zdravila, izdelana iz sestavin krvi, ki jih industrijsko izdelujejo javne ali zasebne ustanove, kot npr. zdravila, ki vključujejo zlasti albumin, koagulacijske faktorje in imunoglobuline človeškega izvora.
English: Adverse reaction:
Slovenian: Neželen učinek :
English: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Slovenian: Neželen učinek zdravila je škodljiva in nenamerna reakcija, ki se pojavi pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni, ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije.
English: Serious adverse reaction:
Slovenian: Resen neželen učinek :
English: An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
Slovenian: Neželena reakcija, ki ima za posledico smrt, neposredno življenjsko ogroženost, zahteva bolnišnično zdravljenje ali podaljšanje obstoječega bolnišničnega zdravljenja, ima za posledico dolgotrajno ali izrazito nezmožnost ali nesposobnost, ali pa prirojeno anomalijo/prirojeno napako.
English: Unexpected adverse reaction:
Slovenian: Nepričakovan neželen učinek :
English: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.
Slovenian: Neželena reakcija, katere vrsta, resnost ali izid ni skladna s povzetkom glavnih značilnosti zdravila.
English: Periodic safety update reports:
Slovenian: Redna poročila o varnosti zdravila :
English: The periodical reports containing the records referred to in Article 104.
Slovenian: Redna poročila, ki vsebujejo dokumentacijo, navedeno v členu 104.
English: Post-authorisation safety study:
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet :
English: A pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product.
Slovenian: Farmakoepidemiološka študija ali klinično preskušanje, izvedeno v skladu s pogoji dovoljenja za promet z zdravilom, katere cilj je opredelitev ali količinska določitev tveganja glede varnosti v zvezi z odobrenim zdravilom.
English: Abuse of medicinal products:
Slovenian: Zloraba zdravil :
English: Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effets.
Slovenian: Trajna ali posamezna namerna prekomerna uporaba zdravil, ki jo spremljajo škodljivi fizični ali psihološki učinki.
English: Wholesale distribution of medicinal products:
Slovenian: Promet z zdravili na debelo :
English: All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public.
Slovenian: Za promet z zdravili na debelo se šteje nakup zdravil, hramba ter prodaja ali izvoz zdravil, razen izdajanja zdravil širši javnosti.
English: Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.
Slovenian: Promet z zdravili na debelo opravljajo proizvajalci ali njihovi depozitarji, uvozniki, drugi trgovci ali pa ga opravljajo farmacevti in osebe, ki imajo v zadevni državi članici dovoljenje za izdajanje zdravil širši javnosti.
English: Public service obligation:
Slovenian: Obveznost javnih storitev :
English: The obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
Slovenian: Obveznost veletrgovcev, da zagotavljajo stalen in ustrezen izbor zdravil, s katerim zadoščajo zahtevam določenega geografskega območja in v zelo kratkem času dostavljajo zahtevane dobave celotnemu zadevnemu območju.
English: Medicinal Prescription:
Slovenian: Zdravniški recept :
English: Any medicinal prescription issued by a professional person qualified to do so.
Slovenian: Vsak recept, ki ga izda strokovna, za to usposobljena oseba.
English: Name of the medicinal product:
Slovenian: Ime zdravila :
English: The name given to a medicinal product, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer;
Slovenian: Ime zdravila, ki je lahko izmišljeno ime ali splošno ali znanstveno ime skupaj z blagovno znamko ali imenom izdelovalca.
English: the invented name shall not be liable to confusion with the common name.
Slovenian: Izmišljeno ime ne sme povzročati zamenjave s splošnim imenom.
English: Common name:
Slovenian: Splošno ime :
English: The international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name.
Slovenian: Mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, ali če tega imena ni, običajno splošno ime.
English: Strength of the medicinal product:
Slovenian: Jakost zdravila :
English: The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.
Slovenian: Vsebnost zdravilnih učinkovin, izražena količinsko na enoto odmerka, na enoto prostornine ali mase, skladno s farmacevtsko obliko.
English: Immediate packaging:
Slovenian: Stična ovojnina :
English: The container or other form of packaging immediately in contact with the medicinal product.
Slovenian: Vsebnik ali druga oblika ovojnine, ki je neposredno v stiku z zdravilom.
English: Outer packaging:
Slovenian: Zunanja ovojnina :
English: The packaging into which is placed the immediate packaging.
Slovenian: Ovojnina, v katero je vložena stična ovojnina.
English: Labelling:
Slovenian: Označevanje :
English: Information on the immediate or outer packaging.
Slovenian: Podatki na stični ali zunanji ovojnini.
English: Package leaflet:
Slovenian: Navodilo za uporabo :
English: A leaflet containing information for the user which accompanies the medicinal product.
Slovenian: Zdravilu priložen listič s podatki, namenjenimi uporabniku.
English: The European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
Slovenian: Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
English: Risk to public health:
Slovenian: Tveganje za javno zdravje :
English: All risks with regard to the quality, safety and efficacy of the medicinal product.
Slovenian: Vsa tveganja glede kakovosti, varnosti in učinkovitosti zdravila.
English: SCOPE
Slovenian: OBSEG
English: The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.
Slovenian: Določbe te direktive se uporabljajo za industrijsko proizvedena zdravila za ljudi, ki se dajejo v promet v državah članicah.
English: Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).
Slovenian: Zdravilo, pripravljeno v lekarni po zdravniškem receptu za posameznega bolnika (splošno znano kot magistralno zdravilo).
English: Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the official formula).
Slovenian: Zdravilo, pripravljeno v lekarni v skladu z recepturami v farmakopeji, namenjeno za neposredno izdajo bolnikom, ki ga dobijo v zadevni lekarni (splošno znano kot galensko zdravilo).
English: Medicinal products intended for research and development trials.
Slovenian: Zdravila, namenjena za raziskave in razvojna preskušanja.
English: Intermediate products intended for further processing by an authorized manufacturer.
Slovenian: Intermediati, namenjeni za nadaljnjo obdelavo s strani pooblaščenega proizvajalca.
English: Any radionuclides in the form of sealed sources.
Slovenian: Vse radionuklide v obliki zaprtih virov.
English: Whole blood, plasma or blood cells of human origin.
Slovenian: Polno kri, plazmo ali krvne celice človeškega izvora.
English: Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment, or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation.
Slovenian: Nič v tej direktivi ne sme na kakršenkoli način odstopati od pravil Skupnosti glede varstva oseb pred sevanjem zaradi zdravniških preiskav ali zdravljenja, ali od predpisov Skupnosti, ki določajo osnovne varnostne standarde za varovanje zdravja širše javnosti in delavcev pred nevarnostmi ionizirajočega sevanja.
English: This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin(20).
Slovenian: Ta direktiva ne vpliva na Odločbo Sveta 86/346/EGS z dne 25. junija 1986, ki je v imenu Skupnosti sprejel Evropski Sporazum o izmenjavi terapevtskih snovi človeškega izvora [20].
English: The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions.
Slovenian: Določbe te direktive ne vplivajo na pooblastila organov držav članic kar zadeva določanje cen zdravil ali vključevanje zdravil v programe nacionalnega zdravstvenega zavarovanja, na podlagi zdravstvenih, ekonomskih in socialnih pogojev.
English: This Directive shall not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients.
Slovenian: Ta direktiva ne vpliva na uporabo nacionalne zakonodaje glede prepovedi ali omejevanja prodaje, izdajanja ali uporabe zdravil kot so kontracepcijska sredstva ali sredstva za prekinitev nosečnosti.
English: The Member States shall communicate the national legislation concerned to the Commission.
Slovenian: Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.
English: A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility.
Slovenian: Država članica lahko v skladu z veljavno zakonodajo ter za zadovoljevanje posebnih potreb, izvzame iz določb te direktive tista zdravila, ki se izdajajo v odgovor na prostovoljno naročilo v dobri veri, pripravljena v skladu s specifikacijami pooblaščenega zdravstvenega strokovnjaka, ki jih bodo njegovi posamezni bolniki uporabljali na njegovo neposredno osebno odgovornost.
English: PLACING ON THE MARKET
Slovenian: DAJANJE ZDRAVIL V PROMET
English: Marketing authorization
Slovenian: Pridobitev dovoljenja za promet z zdravilom
English: No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordance with this Directive or an authorization has been granted in accordance with Regulation (EEC) No 2309/93.
Slovenian: Zdravilo je lahko v državi članici v prometu samo na podlagi dovoljenja za promet z zdravilom, ki ga pristojni organi države članice izdajo v skladu s to direktivo ali v skladu z Uredbo (EGS) št. 2309/93.
English: The authorisation referred to in paragraph 1 shall also be required for radionuclide generators, radionuclide kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals.
Slovenian: Dovoljenje iz odstavka 1 je treba zahtevati tudi za radionuklidne generatorje, redionuklidne komplete, radionuklidne predhodnike radiofarmakov ter industrijsko izdelane radiofarmacevtske izdelke.
English: A marketing authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized radionuclide generators, radionuclide kits or radionuclide precursors in accordance with the manufacturer's instructions.
Slovenian: Dovoljenje za promet se ne zahteva za radiofarmacevtski izdelek, pripravljen v času uporabe, ko ga pooblaščena oseba ali ustanova uporablja v skladu z nacionalno zakonodajo za uporabo tovrstnih zdravil v zdravstveni ustanovi z dovoljenjem, in so proizvedena izključno iz dovoljenih radionuklidnih generatorjev, radionuklidnih kompletov ali radionuklidnih predhodnikov v skladu z navodili proizvajalca.
English: In order to obtain an authorization to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned.
Slovenian: Za pridobitev dovoljenja za dajanje zdravila v promet ne glede na postopek, ki ga določa Uredba (EGS) št. 2309/93, se pri pristojnem organu zadevne države članice vloži vlogo.
English: A marketing authorization may only be granted to an applicant established in the Community.
Slovenian: Dovoljenje za promet z zdravilom se lahko izda samo vlagatelju, ki ima sedež oziroma stalno bivališče v Skupnosti.
English: The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:
Slovenian: Vlogi se priložijo naslednji podatki in dokumenti v skladu s Prilogo I:
English: Name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer.
Slovenian: Ime ali naziv podjetja in stalni naslov vlagatelja ter, kadar je to primerno, proizvajalca.
English: Name of the medicinal product.
Slovenian: Ime zdravila.
English: Qualitative and quantitative particulars of all the constituents of the medicinal product in usual terminology, but excluding empirical chemical formulae, with mention of the international non-proprietary name recommended by the World Health Organization where such name exists.
Slovenian: Podatki o kakovostni in količinski sestavi zdravila, izraženi z običajnimi strokovnimi izrazi, vendar ne v obliki empirične kemijske formule, z navedbo mednarodnega nelastniškega imena, ki ga priporoča Svetovna zdravstvena organizacija, kadar tako ime obstaja.
English: Description of the manufacturing method.
Slovenian: Opis postopka izdelave.
English: Therapeutic indications, contra-indications and adverse reactions.
Slovenian: Terapevtske indikacije, kontraindikacije in neželeni učinki.
English: Posology, pharmaceutical form, method and route of administration and expected shelf life.
Slovenian: Odmerjanje, farmacevtska oblika, način in pot uporabe zdravila in pričakovani rok uporabnosti.
English: If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of any potential risks presented by the medicinal product for the environment.
Slovenian: Če je primerno, se navedejo razlogi za previdnostne in varnostne ukrepe pri shranjevanju zdravila, pri dajanju zdravila bolnikom ter pri odlaganju odpadkov, skupaj z navedbo vseh možnih tveganj, ki jih zdravilo predstavlja za okolje.
English: Description of the control methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests, controls carried out at an intermediate stage of the manufacturing process).
Slovenian: Opis kontrolnih metod, ki jih izdelovalec uporablja (kakovostna in količinska analiza sestavin ter končnega izdelka, posebnih preskusov, npr. preskusi sterilnosti, preskusi prisotnosti pirogenih snovi, prisotnost težkih kovin, preskusi stabilnosti, biološki in toksikološki preskusi, izvedene kontrole vmesnih faz postopka izdelave).
English: Results of:
Slovenian: Rezultati:
English: physico-chemical, biological or microbiological tests,
Slovenian: fizikalno-kemijskih, bioloških in mikrobioloških preskusov,
English: clinical trials.
Slovenian: kliničnih preskušanj.
English: A summary, in accordance with Article 11, of the product characteristics, one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal product, together with a package leaflet.
Slovenian: V skladu s členom 11 povzetek glavnih značilnostih zdravila, en ali več vzorcev ovojnine ali osnutkov zunanje in stične ovojnine zdravila, skupaj z navodilom za uporabo.
English: A document showing that the manufacturer is authorised in his own country to produce medicinal products.
Slovenian: Dokument, ki dokazuje, da ima proizvajalec v svoji državi dovoljenje za proizvodnjo zdravil.
English: Copies of any authorisation obtained in another Member State or in a third country to place the medicinal product on the market, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination.
Slovenian: Kopije vseh dovoljenj za promet z zdravilom, pridobljenih v drugi državi članici ali v tretji državi, skupaj s seznamom tistih držav članic, v katerih je bila vloga za pridobitev dovoljenja za promet predložena v skladu s to direktivo in je v postopku preučevanja.
English: Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21.
Slovenian: Kopije povzetka glavnih značilnosti zdravila, ki jih vlagatelj predlaga v skladu s členom 11 ali ki so ga odobrili pristojni organi države članice v skladu s členom 21.
English: Copies of the package leaflet proposed in accordance with Article 59 or approved by the competent authorities of the Member State in accordance with Article 61.
Slovenian: Kopije navodila za uporabo, predlaganega v skladu s členom 59 ali odobrenega s strani pristojnih organov države članice v skladu s členom 61.
English: Details of any decision to refuse authorization, whether in the Community or in a third country, and the reasons for such a decision.
Slovenian: Podrobne razloge za zavrnitev pridobitve dovoljenja v Skupnosti ali v tretji državi, ter razloge za tako odločitev.
English: This information shall be updated on a regular basis.
Slovenian: Ti podatki se redno ažurirajo.
English: In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars:
Slovenian: Poleg zahtev iz členov 8 in 10(1), vloga za pridobitev dovoljenja za promet radionuklidnega generatorja vsebuje tudi naslednje informacije in podrobnosti:
English: a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation,
Slovenian: splošen opis sistema in podroben opis komponent sistema, ki lahko vplivajo na sestavo ali kakovost hčerinskega nuklidnega pripravka,
English: qualitative and quantitative particulars of the eluate or the sublimate.
Slovenian: podrobnosti o kakovostni in količinski sestavi eluata ali sublimata.
English: In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property:
Slovenian: Z odstopanjem od člena 8(3)(i) in brez vpliva na zakon, ki se nanaša na varstvo industrijske in poslovne lastnine: