FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: forms of interaction with other medicinal products and other forms of interaction
Slovenian: oblike medsebojnega delovanja z drugimi zdravili ter druge oblike interakcij
English: alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product,
Slovenian: (npr. alkohol, tobak, hrana), ki lahko vplivajo na delovanje zdravila,
English: special warnings;
Slovenian: posebna opozorila;
English: this list must:
Slovenian: seznam mora:
English: take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),
Slovenian: upoštevati posebno stanje nekaterih skupin uporabnikov (npr. otroci, nosečnice ali doječe matere, starostniki, osebe s posebnimi patološkimi stanji),
English: mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,
Slovenian: navajati, če je primerno, možen vpliv na sposobnost vožnje ali upravljanja s stroji,
English: detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 65;
Slovenian: navajati tiste pomožne snovi, katerih poznavanje je pomembno za varno in učinkovito uporabo zdravila in so vključene v smernice, objavljene v skladu s členom 65;
English: the necessary and usual instructions for proper use, in particular:
Slovenian: običajni podatki, ki so potrebni za pravilno uporabo, zlasti: in, kadar je primerno, odvisno od vrste zdravila:
English: the dosage,
Slovenian: odmerjanje,
English: the method and, if necessary, route of administration,
Slovenian: postopek, in če je potrebno, pot uporabe zdravila,
English: the frequency of administration, specifying if necessary, the appropriate time at which the medicinal product may or must be administered,
Slovenian: pogostost uporabe zdravila, po potrebi z navedbo primernega časa, ko se zdravilo sme ali mora dajati,
English: and, as appropriate, depending on the nature of the product:
Slovenian: in, kadar je primerno, odvisno od vrste zdravila:
English: the duration of treatment, where it should be limited,
Slovenian: trajanje zdravljenja, kadar bi moralo biti omejeno,
English: the action to be taken in the case of an overdose (e.g., symptoms, emergency procedures),
Slovenian: ukrepi, ki jih je treba sprejeti v primeru prevelikega odmerjanja (npr. simptomi, nujni ukrepi),
English: the course of action to take when one or more doses have not been taken,
Slovenian: način ukrepanja, če je bolnik izpustil enega ali več odmerkov,
English: indication, if necessary, of the risk of withdrawal effects;
Slovenian: navedba, če je to potrebno, glede tveganja zaradi učinkov ob prenehanju jemanja zdravila;
English: a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case;
Slovenian: opis neželenih učinkov, ki se lahko pojavijo pri običajni uporabi zdravila, in če je potrebno, ukrepe, ki jih je treba sprejeti v takem primeru;
English: the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist;
Slovenian: bolnika je treba izrecno pozvati, da o vseh neželenih učinkih, ki niso navedeni v navodilu, takoj obvesti zdravnika ali farmacevta;
English: a reference to the expiry date indicated on the label, with:
Slovenian: napotitev glede datuma izteka roka uporabnosti, navedenega na ovojnini, z:
English: a warning against using the product after this date,
Slovenian: opozorilom, da se zdravilo po navedenem datumu izteka roka uporabnosti ne sme uporabljati,
English: where appropriate, special storage precautions,
Slovenian: kadar je primerno, posebna navodila za shranjevanje,
English: if necessary, a warning against certain visible signs of deterioration;
Slovenian: če je potrebno, opozorilo v zvezi z določenimi vidnimi znaki kvarjenja;
English: the date on which the package leaflet was last revised.
Slovenian: datum zadnje revizije navodila za uporabo.
English: Notwithstanding paragraph 1(b), the authority competent may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient.
Slovenian: Ne glede na odstavek 1(b) lahko pristojni organ odloči, da se nekatere terapevtske indikacije ne navedejo v navodilu za uporabo, če bi bilo širjenje tovrstnih informacij lahko zelo neugodno za bolnika.
English: Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title.
Slovenian: Na svojem ozemlju države članice ne smejo prepovedati ali ovirati dajanja zdravil v promet v zvezi z označevanjem ali navodilom za uporabo, kadar sta v skladu z zahtevami tega naslova.
English: One or more specimens or mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorizing marketing when the marketing authorization is requested.
Slovenian: V vlogi za pridobitev dovoljenja za promet se organom, pristojnim za izdajo dovoljenja za promet z zdravilom, predloži en ali več vzorcev ovojnine ali osnutkov zunanje in stične ovojnine zdravila ter osnutek navodila za uporabo.
English: The competent authority shall refuse the marketing authorization if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics.
Slovenian: Pristojni organ zavrne pridobitev dovoljenja za promet z zdravilom, če označevanje ali navodilo za uporabo nista v skladu z določbami tega naslova ali če nista v skladu s podrobnimi podatki iz povzetka glavnih značilnosti zdravila.
English: All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorizing marketing.
Slovenian: Vse predlagane spremembe z vidika označevanja ali navodila za uporabo, zajete v tem naslovu, ki niso povezane s povzetkom glavnih značilnosti zdravila, se predložijo organom, pristojnim za izdajo dovoljenja za promet z zdravilom.
English: If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.
Slovenian: Če pristojni organi ne nasprotujejo predlagani spremembi v 90 dneh po predložitvi vloge, vlagatelj spremembo lahko uveljavi.
English: The fact that the competent authority do not refuse a marketing authorization pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer or as appropriate the marketing authorization holder.
Slovenian: Dejstvo, da pristojni organ ne zavrne pridobitve dovoljenja za promet z zdravilom na podlagi odstavka 2, ali spremembe označevanja ali navodila za uporabo na podlagi odstavka 3, ne spremeni splošne pravne odgovornosti proizvajalca ali, kadar je primerno, imetnika dovoljenja za promet z zdravilom.
English: The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature.
Slovenian: Zunanja ovojnina in navodilo za uporabo lahko vsebujeta simbole ali piktograme, katerih namen je razjasnitev nekaterih informacij iz členov 54 in 59(1) in drugih informacij v skladu s povzetkom glavnih značilnosti zdravila, ki so koristne za zdravstveno vzgojo, z izjemo vseh elementov, ki so promocijske narave.
English: The particulars for labelling listed in Articles 54, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market.
Slovenian: Podrobni podatki za označevanje iz členov 54, 59 in 62 so napisani v uradnem jeziku ali jezikih države članice, kjer je zdravilo v prometu.
English: The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.
Slovenian: Prvi pododstavek ne preprečuje navedbe teh podrobnih podatkov v več jezikih pod pogojem, da se isti podatki navedejo v vseh jezikih, ki se uporabljajo.
English: The package leaflet must be written in clear and understandable terms for the users and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market.
Slovenian: Navodilo za uporabo mora biti napisano z izrazi, ki so uporabnikom jasni in razumljivi, in biti čitljivi v uradnem jeziku ali jezikih države članice, kjer je zdravilo v prometu.
English: The first subparagraph shall not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used.
Slovenian: Prvi pododstavek ne preprečuje tiskanja navodila za uporabo v več jezikih pod pogojem, da se iste informacije navedejo v vseh jezikih, ki se uporabljajo.
English: The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.
Slovenian: Pristojni organi lahko določijo, da na ovojnini in navodilih za uporabo določenih zdravil ni obvezna navedba nekaterih podrobnih podatkov ali da mora biti navodilo za uporabo v uradnem jeziku ali jezikih države članice, kjer je zdravilo v prometu, če zdravilo ni namenjeno bolniku, da bi si ga apliciral sam.
English: Where the provisions of this Title are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorization, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Title.
Slovenian: Kadar se določbe tega naslova ne upoštevajo in se zadevna oseba ne odzove na poslani opomin, pristojni organi države članice lahko začasno umaknejo dovoljenje za promet z zdravilom, dokler sporna ovojnina in navodilo za uporabo zdravila nista v skladu z zahtevami tega naslova.
English: As necessary, the Commission shall publish guidelines concerning in particular:
Slovenian: Kadar je potrebno Komisija objavi zlasti smernice o:
English: the formulation of certain special warnings for certain categories of medicinal products,
Slovenian: obliki navajanja nekaterih posebnih opozoril za določene skupine zdravil,
English: the particular information needs relating to self-medication,
Slovenian: potrebah po posebnih informacijah v zvezi s samozdravljenjem,
English: the legibility of particulars on the labelling and package leaflet,
Slovenian: čitljivosti podrobnih podatkov na ovojnini in navodilu za uporabo,
English: methods for the identification and authentication of medicinal products,
Slovenian: načinih za identifikacijo in ugotavljanje avtentičnosti zdravil,
English: the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated.
Slovenian: seznam pomožnih snovi, ki jih je treba navesti na ovojnini zdravil, ter način, kako je treba te pomožne snovi navesti.
English: These guidelines shall be adopted in the form of a Directive, in accordance with the procedure referred to in Article 121(2).
Slovenian: Smernice se sprejmejo v obliki direktive, v skladu s postopkom iz člena 121(2).
English: The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency.
Slovenian: Zunanja ovojnina in vsebnik zdravil, ki vsebujejo radionuklide, se označita v skladu s predpisi o varnem prevozu radioaktivnih snovi, ki jih je določila Mednarodna agencija za atomsko energijo.
English: Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3.
Slovenian: Oznaka mora biti tudi v skladu z določbami odstavkov 2 in 3.
English: The label on the shielding shall include the particulars mentioned in Article 54.
Slovenian: Nalepka na zaščitni ovojnini vsebuje podrobne podatke iz člena 54.
English: In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.
Slovenian: Nalepka na zaščitni ovojnini v celoti pojasnjuje uporabljene kode na viali in navaja, kadar je to potrebno, za navedeni čas in datum, skupno radioaktivnost na odmerek ali na vialo, ter število kapsul ali, pri tekočinah, število mililitrov v vsebniku.
English: The vial shall be labelled with the following information:
Slovenian: Na viali so oznake z naslednjimi informacijami:
English: the name or code of the medicinal product, including the name or chemical symbol of the radionuclide,
Slovenian: ime ali koda zdravila, vključno z imenom ali kemijskim simbolom radionuklida,
English: the batch identification and expiry date,
Slovenian: identifikacija serije ter datum izteka roka uporabnosti,
English: the international symbol for radioactivity,
Slovenian: mednarodni simbol za radioaktivnost,
English: the name of the manufacturer,
Slovenian: ime proizvajalca,
English: the amount of radioactivity as specified in paragraph 2.
Slovenian: skupno radioaktivnost, kakor je navedeno v odstavku 2.
English: The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors.
Slovenian: Pristojni organ zagotovi, da je v vsakem pakiranju pri radiofarmacevtskih izdelkih, radionuklidnih generatorjih, radionuklidnih kompletih ali radionuklidnih predhodnikih priloženo podrobno navodilo za uporabo.
English: The text of this leaflet shall be established in accordance with the provisions of Article 59.
Slovenian: Besedilo navodila za uporabo je sestavljeno v skladu z določbami člena 59.
English: In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents.
Slovenian: Navodilo za uporabo poleg tega vključuje tudi varnostne ukrepe, ki jih morata uporabnik in bolnik upoštevati med pripravo in dajanjem zdravila, ter posebne varnostne ukrepe za odstranjevanje ovojnine in neuporabljene vsebine.
English: Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.
Slovenian: Brez poseganja v določbe člena 69 se homeopatska zdravila označujejo v skladu z določbami tega naslova, na ovojnini pa mora biti v jasni in čitljivi obliki oznaka o homeopatski naravi izdelka.
English: In addition to the clear mention of the words "homeopathic medicinal product", the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information:
Slovenian: Poleg jasne navedbe besed "homeopatsko zdravilo", ovojnina, in kadar je to primerno, navodilo za uporabo zdravila iz člena 14(1), vsebuje tudi naslednje in nobenih drugih informacij:
English: the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5),
Slovenian: znanstveno ime homeopatske surovine ali surovin, ki mu sledi stopnja razredčitve z uporabo simbolov iz farmakopeje, v skladu s členom 1(5),
English: name and address of the registration holder and, where appropriate, of the manufacturer,
Slovenian: ime in naslov osebe, odgovorne za dajanje zdravila v promet, in kadar je to primerno, proizvajalca,
English: method of administration and, if necessary, route,
Slovenian: postopek uporabe homeopatskega zdravila, in če je potrebno, pot,
English: expiry date, in clear terms (month, year),
Slovenian: jasno naveden datum izteka roka uporabnosti (mesec, leto),
English: pharmaceutical form,
Slovenian: farmacevtsko obliko,
English: special storage precautions, if any,
Slovenian: posebna navodila za shranjevanje, če obstajajo,
English: a special warning if necessary for the medicinal product,
Slovenian: posebno opozorilo za zdravilo, če je potrebno,
English: manufacturer's batch number,
Slovenian: proizvajalčeva številka serije,
English: registration number,
Slovenian: številko registracije,
English: "homeopathic medicinal product without approved therapeutic indications",
Slovenian: "homeopatsko zdravilo brez odobrenih terapevtskih indikacij",
English: a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product.
Slovenian: opozorilo z nasvetom uporabniku, da se posvetuje z zdravnikom, če se med uporabo zdravila znaki bolezni ne izboljšajo.
English: Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:
Slovenian: Ne glede na odstavek 1, države članice lahko zahtevajo uporabo nekaterih vrst oznak za prikaz:
English: the conditions for refunds by social security bodies.
Slovenian: pogoje za nadomestilo s strani organov socialnega varstva.
English: CLASSIFICATION OF MEDICINAL PRODUCTS
Slovenian: RAZVRŠČANJE ZDRAVIL
English: When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into:
Slovenian: Ko je dovoljenje za promet z zdravilom izdano, pristojni organi razvrstijo zdravilo v skupino:
English: a medicinal product subject to medical prescription,
Slovenian: zdravil, ki se izdajajo le na recept,
English: a medicinal product not subject to medical prescription.
Slovenian: zdravil, ki se izdajajo brez recepta.
English: To this end, the criteria laid down in Article 71(1) shall apply.
Slovenian: V ta namen se uporabljajo merila iz člena 71(1).
English: The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only.
Slovenian: Pristojni organi lahko določijo podskupine za zdravila, ki se izdajajo le na recept.
English: In that case, they shall refer to the following classification:
Slovenian: Podskupine so naslednje:
English: medicinal products on renewable or non-renewable medical prescription;
Slovenian: zdravila, ki se izdajajo na obnovljiv ali neobnovljiv zdravniški recept;
English: medicinal products subject to special medical prescription;
Slovenian: zdravila, ki se izdajajo na poseben zdravniški recept;
English: medicinal products on restricted medical prescription, reserved for use in certain specialized areas.
Slovenian: zdravila, ki se izdajajo na zdravniški recept in so namenjena izključno za uporabo na določenih specializiranih področjih.
English: Medicinal products shall be subject to medical prescription where they:
Slovenian: Zdravila so predmet zdravniškega recepta, kadar:
English: are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or
Slovenian: bi verjetno lahko predstavljala neposredno ali posredno nevarnost tudi ob pravilni uporabi, če bi se uporabljala brez zdravniškega nadzora, ali
English: are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
Slovenian: se pogosto in v veliki meri nepravilno uporabljajo, kar bi kot posledica verjetno lahko predstavljalo neposredno ali posredno nevarnost za človekovo zdravje, ali
English: contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or
Slovenian: vsebujejo snovi ali pripravke iz teh snovi, katerih delovanje in/ali neželene učinke je treba nadalje raziskati, ali
English: are normally prescribed by a doctor to be administered parenterally.
Slovenian: jih običajno predpisuje zdravnik in so namenjena parenteralni uporabi.
English: Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors:
Slovenian: Kadar države članice določijo podskupine zdravil, ki so predmet zdravniškega recepta, upoštevajo naslednje dejavnike:
English: the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force, such as the United Nations Conventions of 1961 and 1971, or
Slovenian: zdravilo vsebuje snov v količini, ki ni izvzeta iz posebnih določil konvencije in se uvršča med narkotične in psihotropne snovi v smislu mednarodno veljavnih konvencij, kot sta konvenciji Združenih narodov iz leta 1961 in 1971, ali
English: the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or
Slovenian: zdravilo verjetno lahko ob nepravilni uporabi predstavlja precejšnje tveganje za medicinsko zlorabo, vodi do zasvojenosti ali zlorabe v nedovoljene namene, ali
English: the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in the second indent as a precautionary measure.
Slovenian: zdravilo vsebuje snov, ki bi se zaradi svoje novosti ali lastnosti lahko obravnavala kot da sodi v skupino, predvideno v drugi alinei kot previdnostni ukrep.
English: Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors:
Slovenian: Kadar države članice določijo podskupine zdravil, ki so namenjena izključno za uporabo na določenih specializiranih področjih, upoštevajo naslednje dejavnike:
English: the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment,
Slovenian: zdravilo je, zaradi svojih farmacevtskih lastnosti ali novosti ali zaradi varovanja javnega zdravja, namenjeno za zdravljenja, ki jih je mogoče spremljati samo v bolnišničnem okolju,
English: the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or
Slovenian: zdravilo se uporablja za zdravljenje stanj, ki jih je treba diagnosticirati v bolnišničnem okolju ali v institucijah z ustrezno diagnostično opremo, čeprav se dajanje zdravila in spremljanje lahko izvajata drugod, ali
English: the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment.
Slovenian: zdravilo je namenjeno za ambulantne bolnike, toda njegova uporaba lahko povzroči zelo resne neželene učinke, kar zahteva recept zdravnika specialista in poseben nadzor med zdravljenjem.
English: A competent authority may waive application of paragraphs 1, 2 and 3 having regard to:
Slovenian: Pristojni organ lahko opusti uporabo odstavkov 1, 2 in 3 ob upoštevanju: