FrancophonIA/ELRC3.0 huggingface dataset:
English: In cats Meloxoral is used to alleviate inflammation and pain in chronic musculo-skeletal disorders.
Slovenian: Zdravilo Meloxoral se pri mačkah uporablja za umirjanje vnetja in lajšanje bolečine pri kroničnih kostno-mišičnih obolenjih.
English: How does Meloxoral work?
Slovenian: Kako zdravilo Meloxoral deluje?
English: What are the side-effects of Meloxoral?
Slovenian: Kakšni so neželeni učinki zdravila Meloxoral?
English: What is Meloxoral?
Slovenian: Kaj je zdravilo Meloxoral?
English: The company presented information from scientific articles already published on 90Y.
Slovenian: Podjetje je predložilo podatke iz znanstvenih člankov, ki so že bili objavljeni o 90Y.
English: These may be substances such as antibodies that have been designed to recognise a particular type of cells in the body, including tumour cells.
Slovenian: To so lahko snovi, kot na primer protitelesa, ki so bila načrtovana za razpoznavanje posebnih vrst celic v telesu, vključno s tumorskimi celicami.
English: The marketing authorisation was renewed on 24 March 2008.
Slovenian: Dovoljenje za promet je bilo podaljšano dne 24. marca
English: It emits beta radiation.
Slovenian: Oddaja žarke beta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ytracis to CIS bio international on 24 March 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ytracis, veljavno po vsej Evropski uniji, odobrila družbi CIS bio international dne 24. marca 2003.
English: If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Če potrebujete več podatkov o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: These medicines act as carrier to take the radioactivity to where it is needed.
Slovenian: Ta zdravila delujejo kot nosilci, ki prenesejo radioaktivnost tja, kjer je potrebna.
English: A medicine labelled with Ytracis should not be used in women who are or may be pregnant.
Slovenian: Zdravila, označenega z zdravilom Ytracis, se ne sme uporabljati pri ženskah, ki so noseče ali bi lahko bile noseče.
English: Ytracis must not be given directly to any patient.
Slovenian: Zdravilo Ytracis se nobenemu bolniku ne sme dati neposredno.
English: What benefit has Ytracis shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ytracis izkazalo med raziskavami?
English: 90Y, yttrium-90, is a radioactive form of the chemical element yttrium.
Slovenian: 90Y, itrij-90, je radioaktivna oblika kemijskega elementa itrija.
English: Ytracis is never given on its own.
Slovenian: Zdravilo Ytracis se nikoli ne sme dajati samo.
English: An example of its use is the treatment of some types of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour.
Slovenian: Primer njegove uporabe je zdravljenje nekaterih vrst tumorjev, kjer radioaktivno označeno zdravilo prenese radioaktivnost na mesto, kjer se tumor nahaja.
English: The doctor who prescribes Ytracis must ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
Slovenian: Zdravnik, ki zdravilo Ytracis predpisuje, se mora prepričati, da so tveganja, povezana z radioaktivnim izpostavljanjem, manjša od tveganj, povezanih s samo boleznijo.
English: The company also presented published information supporting the use of 90Y in radiolabelling other medicines.
Slovenian: Podjetje je predložilo tudi objavljene podatke, ki podpirajo uporabo 90Y pri radioaktivnem označevanju drugih zdravil.
English: As Ytracis is a ‘precursor' and will not be given on its own, no studies have been done in humans.
Slovenian: Ker je zdravilo Ytracis „predhodnik“ in se ne uporablja samostojno, ni bilo opravljenih nobenih študij pri ljudeh.
English: It must be mixed outside the body, usually in a laboratory, with the medicine that needs radiolabelling.
Slovenian: Zunaj telesa, običajno v laboratoriju, ga je treba zmešati z zdravilom, ki ga je treba radioaktivno označiti.
English: Ytracis will only be handled and given by people who have experience in the safe handling of radioactive material.
Slovenian: Z zdravilom Ytracis lahko rokujejo in ga dajejo le ljudje, ki imajo izkušnje z varnim rokovanjem z radioaktivnim materialom.
English: The Committee recommended that Ytracis be given marketing authorisation.
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom Ytracis.
English: In the case of Ytracis, the product is used to label medicines that have been specially developed for use with the active ingredient yttrium (90Y) chloride.
Slovenian: V primeru zdravila Ytracis se izdelek uporablja za označevanje zdravil, ki so bila posebej razvita za uporabo z aktivno sestavino itrijev (90Y) klorid.
English: As Ytracis is a precursor and will not be given on its own, it has no side effects.
Slovenian: Ker je zdravilo Ytracis "predhodnik" in se ne uporablja samostojno, nima neželenih stranskih učinkov.
English: Once there, the radioactivity from Ytracis helps to destroy the tumour.
Slovenian: Po tem, ko je enkrat na tistem mestu, radioaktivnost iz zdravila Ytracis pomaga uničiti tumor.
English: Medicines radiolabelled with Ytracis should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients.
Slovenian: Zdravil, ki so radioaktivno označena z zdravilom Ytracis, ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) itrijev klorid ali katero koli drugo sestavino zdravila.
English: The full EPAR for Ytracis is available here.
Slovenian: Celotno Evropsko javno poročilo o oceni (EPAR) za zdravilo Ytracis je na voljo tukaj.
English: The active substance in Ytracis, yttrium (90Y) chloride, is a radioactive compound.
Slovenian: Zdravilna učinkovina v zdravilu Ytracis, itrijev (90Y) klorid, je radioaktivna snov.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Ytracis's benefits are greater than its risks for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ytracis pri radioaktivnem označevanju nosilnih molekul, ki so bile posebej razvite in odobrene za radioaktivno označevanje s tem radionuklidom, večje od z njim povezanih tveganj.
English: Other information about Ytracis:
Slovenian: Druge informacije o zdravilu Ytracis:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YTRACIS EPAR summary for the public
Slovenian: Povzetek EPAR za javnost
English: These side effects will depend on the medicine being used, and they will be described in the Package Leaflet of the medicine labelled with Ytracis.
Slovenian: Ti neželeni stranski učinki so odvisni od uporabljenega zdravila in so opisani v Navodilu za uporabo zdravila, označenega z zdravilom Ytracis.
English: Ytracis is radioactive and its use may carry a risk of cancer and hereditary defects.
Slovenian: Zdravilo Ytracis je radioaktivno, njegova uporaba pa je lahko povezana s tveganjem za pojav rakavega obolenja ali prirojenih okvar.
English: The 90Y contained in Ytracis then attaches itself to the carrier medicine and the resulting mixture is given according to the instructions in the Package Leaflet of the carrier medicine.
Slovenian: 90Y, ki ga vsebuje zdravilo Ytracis, se nato pripoji na nosilno zdravilo, dobljeno mešanico pa je treba dati skladno z Navodilom za uporabo nosilnega zdravila.
English: The quantity of Ytracis needed for radiolabelling and the quantity of the radiolabelled medicine that is given will depend on the medicine that is radiolabelled and the disease that is being treated.
Slovenian: Količina zdravila Ytracis, potrebna za radioaktivno označevanje, in količina radioaktivno označenega zdravila, ki se uporabi, je odvisna od zdravila, ki se radioaktivno označuje, in bolezni, ki se zdravi.
English: What is Ytracis used for?
Slovenian: Za kaj se zdravilo Ytracis uporablja?
English: More information on the restrictions for the medicines radiolabelled with Ytracis will be given in the Package Leaflet of the particular medicine that is radiolabelled with Ytracis.
Slovenian: Več podatkov o omejitvah za zdravila, ki so radioaktivno označena z zdravilom Ytracis, je navedenih v Navodilu za uporabo določenega zdravila, ki je radioaktivno označeno z zdravilom Ytracis.
English: Patients may experience side effects following the injection of the medicine radiolabelled with Ytracis.
Slovenian: Pri bolnikih se lahko pojavijo neželeni stranski učinki po injiciranju zdravila, ki je radioaktivno označeno z zdravilom Ytracis.
English: Ytracis is used for radiolabelling.
Slovenian: Zdravilo Ytracis se uporablja za radioaktivno označevanje.
English: How is Ytracis used?
Slovenian: Kako se zdravilo Ytracis uporablja?
English: The effect of Ytracis depends on the nature of the carrier medicine that is radiolabelled with Ytracis.
Slovenian: Učinek zdravila Ytracis je odvisen od nosilnega zdravila, ki je radioaktivno označeno z zdravilom Ytracis.
English: The effects of the medicine that is radiolabelled with Ytracis will be fully explained in its Package Leaflet.
Slovenian: Učinki zdravila, ki je radioaktivno označeno z zdravilom Ytracis, bodo v celoti razloženi v pripadajočem Navodilu za uporabo.
English: The information supplied by the company supports the use of Ytracis as a precursor for radiolabelling medicines with 90Y.
Slovenian: Podatki, ki jih je priskrbelo podjetje, podpirajo uporabo zdravila Ytracis kot „predhodnika“ za radioaktivno označevanje zdravil z 90Y.
English: Ytracis is a solution containing the active substance yttrium (90Y) chloride.
Slovenian: Zdravilo Ytracis je raztopina, ki vsebuje zdravilno učinkovino itrijev (90Y) klorid.
English: How does Ytracis work?
Slovenian: Kako zdravilo Ytracis deluje?
English: What is the risk associated with Ytracis?
Slovenian: Kakšna tveganja so povezana z zdravilom Ytracis?
English: Why has Ytracis been approved?
Slovenian: Zakaj je bilo zdravilo Ytracis odobreno?
English: Version 10.1, 06/201902/2016
Slovenian: Različica 10.1, 0206/2016 2019 Language rev.1, 04/2016
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/000
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/0/00/000/000
English: • <Additional risk minimisation measures>
Slovenian: • <Dodatni ukrepi za zmanjševanje tveganj>
English: <{Адрес} {Град} {Пощенски код}> Teл.
Slovenian: {Град} {Пощенски код}> Teл.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.> <Paediatric population>
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.> <Pediatrična populacija>
English: 4.8 Undesirable effects <Paediatric population>
Slovenian: 4.8 Neželeni učinki <Pediatrična populacija>
English: <Mechanism of action> <Pharmacodynamic effects> <Clinical efficacy and safety> <Paediatric population>
Slovenian: <Mehanizem delovanja> <Farmakodinamični učinki> <Klinična učinkovitost in varnost> <Pediatrična populacija>
English: <The requirements for submission of PSURs periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Slovenian: <Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravilaPSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.>
English: <Absorption> <Distribution> <Biotransformation> <Elimination> <Linearity/non-linearity> <Pharmacokinetic/pharmacodynamic relationship(s)>
Slovenian: <Porazdelitev> <Biotransformacija> <Izločanje> <Linearnost/nelinearnost> <Farmakokinetično/farmakodinamično razmerje>
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Mmarketing Aauthorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • Risk Mmanagement Pplan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <{MM/LLLL}> <{DD/MM/LLLL}> <{DD. mesec LLLL}>
English: 4.5 Interaction with other medicinal products and other forms of interaction <No interaction studies have been performed.> <Paediatric population> <Interaction studies have only been performed in adults.> 4.6 Fertility, pregnancy and lactation <Pregnancy> <Breast-feeding> <Fertility>
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij <Študij medsebojnega delovanja niso izvedli.> <Pediatrična populacija> <Študije medsebojnega delovanja so izvedli le pri odraslih.> 4.6 Plodnost, nosečnost in dojenje <Nosečnost> <Dojenje> <Plodnost>
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Slovenian: <Zdravilo {X} je indicirano pri <odraslih> <novorojencčkih> <dojenčkih> <otrocih> <mladostnikih>, <starih {x do y}> <let> <mesecev>.>
English: 6.3 Shelf life <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...> 6.4 Special precautions for storage <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Slovenian: 6.3 Rok uporabnosti <...> <6 mesecev> <...> <1 leto> <18 mesecev> <2 leti> <30 mesecev> <3 leta> <...> 6.4 Posebna navodila za shranjevanje <Za pogoje shranjevanja po <rekonstituciji> <redčenju> <prvem odprtju> zdravila glejte poglavje
English: OTHER SPECIAL WARNING(S), IF NECESSARY <For autologous use only.>
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA <Samo za avtologno uporabo.>
English: 6.2 Incompatibilities <Not applicable.> <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.> <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Slovenian: 6.2 Inkompatibilnosti <Navedba smiselno ni potrebna.> <Zaradi V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.> <Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju <6.6> <in>
English: <The marketing authorisation holder (MAH) shall submit the first PSUR periodic safety update report for this product within 6 months following authorisation.>
Slovenian: <Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravilaPSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.>
English: 4.7 Effects on ability to drive and use machines <{(Invented) name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.> <Not relevant.>
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev <Zdravilo {izmišljeno ime} <nima vpliva ali ima zanemarljiv vpliv> <ima blag vpliv> <ima zmeren vpliv> <ima pomemben vpliv> na sposobnost vožnje in upravljanja strojev.> <Podatek ni potreben.>
English: OTHER <For autologous use only.>
Slovenian: DRUGI PODATKI <Samo za avtologno uporabo.>
English: 6.5 Nature and contents of container <and special equipment for use, administration or implantation> <Not all pack sizes may be marketed.>
Slovenian: 6.5 Vrsta ovojnine in vsebina <ter posebna oprema za uporabo, dajanje ali implantacijo> <Na trgu morda ni vseh navedenih pakiranj.>
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Slovenian: <Datum prve odobritve: <{DD. mesec LLLL}> <Datum zadnjega podaljšanja: <{DD. mesec LLLL}>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.> <Do not use this medicine if you notice {description of the visible signs of deterioration}.> <Do not throw away any medicines via wastewater <or household waste>.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na <nalepki> <škatli> <steklenici> <...> <poleg oznake {okrajšava za rok uporabnosti}.> <Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.> <Ne uporabljajte tega zdravila, če opazite {opis vidnih znakov kvarjenja}.> <Zdravila ne smete odvreči v odpadne vode <ali med gospodinjske odpadke>.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION <2.1 General description> [For advanced therapy products only] <2.2 Qualitative and quantitative composition> [For advanced therapy products only] <Excipient(s) with known effect> <For the full list of excipients, see section 6.1.>
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA <2.1 Splošen opis> [Samo za zdravila za napredno zdravljenje] <2.2 Kakovostna in količinska sestava> [Samo za zdravila za napredno zdravljenje] <Pomožna(e) snov(i) z znanim učinkom:> <Za celoten seznam pomožnih snovi glejte poglavje 6.1.>
English: <The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.> <The score line is not intended for breaking the tablet.> <The tablet can be divided into equal doses.>
Slovenian: FARMACEVTSKA OBLIKA <Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.> <Zareza ni namenjena delitvi tablete.> <Tableta se lahko deli na <enaka odmerka> <enake odmerke>.>
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for X, such as this leaflet.>
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke za referenčno zdravilo, ki bodo na voljo, in kakršne koli posodobitve informacij o referenčnem zdravilu bodo vključene tudi v informacije o zdravilu X, npr. v to navodilo za uporabo.
English: See the end of section 4 for how to report side effects.> [For medicinal products subject to additional monitoring ONLY]
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.> [SAMO za zdravila, za katera se izvaja dodatno spremljanje varnosti.]
English: <An updated RMP shall be submitted by {CHMP agreed deadline}.> <Not applicable.>
Slovenian: <Posodobljen RMP je treba predložiti do{skrajni rok, ki ga določi CHMP}>.
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.> <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Slovenian: <<Varnost> <in> <učinkovitost> zdravila {X} pri otrocih, starih {x do y} <mesecev> <let>, [ali drugi primerni skupini, npr. glede na telesno maso, dobo pubertete, spol] <še> <ni> <nista> <bila> <bili> <dokazana><dokazani>.> <Podatkov ni na voljo.> <Trenutno razpoložljivi podatki so opisani v poglavju <4.8> <5.1> <5.2>, vendar priporočil o odmerjanju ni mogoče dati.>
English: STATEMENT OF ACTIVE SUBSTANCE(S) <This product contains cells of <human> <animal> origin.>
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN <Zdravilo vsebuje celice <humanega> <živalskega> izvora.>
English: <Post-authorisation efficacy study (PAES):> <Non-interventional post-authorisation safety study (PASS):>>
Slovenian: <Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES):> <Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):>>
English: <This being a conditional marketing authorisation and pursuant to Article 14a(47) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Slovenian: <Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(74) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:>
English: 6.1 List of excipients <None.>
Slovenian: 6.1 Seznam pomožnih snovi <Jih ni.>
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE <Name and address of the manufacturer(s) of the biological active substance(s) {Name and address}> <Name and address of the manufacturer(s) responsible for batch release> {Name and address} <The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
Slovenian: SERIJ <Ime in naslov izdelovalproizvajalca (izdelovalproizvajalcev) biološke učinkovine (učinkovin) {Ime in naslov}> <Ime in naslov izdelovalproizvajalca (izdelovalproizvajalcev), odgovornega (odgovornih) za sproščanje serij> {Ime in naslov} <V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalproizvajalca, odgovornega za sprostitev zadevne serije.>
English: < This medicine is subject to additional monitoring.
Slovenian: < Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: • <Official batch release
Slovenian: <Uradna sprostitev serije:
English: • Periodic Ssafety Uupdate Rreports (PSURs)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: <Additional side effects in children <and adolescents>> Reporting of side effects
Slovenian: <Dodatni neželeni učinki pri otrocih <in mladostnikih>>
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> <Not applicable.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.> <Navedba smiselno ni potrebna.>
English: Ísland {Nafn} <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer}
Slovenian: Ísland {Nafn} <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer} <{Netfang }>
English: <{(Invented) Nname} is a biosimilar medicinal product.
Slovenian: <Zdravilo {(izmišljeno) ime} je podobno biološko zdravilo.
English: What X is and what it is used for <You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo <Če se znaki vaše bolezni poslabšajo ali ne izboljšajo <v {število} dneh>, se morate posvetovati posvetujte z zdravnikom.>
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>>
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI <POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM> <DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH>>
English: <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. <IZDELOVALPROIZVAJALEC (IZDELOVALPROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN> IZDELOVALPROIZVAJALEC (IZDELOVALPROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ