FrancophonIA/ELRC3.0 huggingface dataset:
English: The Management Board noted the upcoming written procedures regarding changes to the feeimplementing rules.
Slovenian: Upravni odbor se je seznanil s prihodnjimi pisnimi postopki v zvezi s spremembami izvedbenih pravil za pristojbine.
English: The Management Board noted the Executive Director's presentation on the ongoing work to review the Agency's organisational structure.
Slovenian: Upravni odbor se je seznanil s predstavitvijo izvršnega direktorja o tekočem delu za pregled organizacijske strukture Agencije.
English: The Board wished to be informed of the outcome of this discussion and the rationale for the future agreement between the CAT and CHMP on this issue.
Slovenian: Odbor želi biti obveščen o rezultatu te razprave in utemeljitvi prihodnjega sporazuma o tem vprašanju, ki naj bi ga sklenila odbora CAT in CHMP.
English: The latter is a new sector with responsibilities for centralising product-information management at the Agency and for improving the interoperability of databases.
Slovenian: To je popolnoma nov sektor, ki je odgovoren za centralizacijo upravljanja podatkov o zdravilih pri Agenciji in izboljšanje povezljivosti podatkovnih zbirk.
English: The written procedures will include fees for veterinary medicinal products indicated for minor uses and minor species/limited markets, and fees for medicinal products to be used in a health pandemic that affects humans.
Slovenian: Pisni postopki bodo zajemali pristojbine za zdravila za uporabo v veterinarski medicini, namenjena manjši uporabi in manj pomembnim vrstam/omejenim trgom, in pristojbine za zdravila, namenjena uporabi v primeru zdravstvene pandemije, ki prizadene ljudi.
English: Preliminary draft budget 2010
Slovenian: Predhodni osnutek proračuna za leto 2010
English: [EMEA/261645/2008] The Management Board endorsed the proposal for a pilot project that aims for greater involvement of patients and consumers in the work of the Agency.
Slovenian: [EMEA/261645/2008] Upravni odbor je potrdil predlog pilotnega projekta, namenjenega večji vključenosti bolnikov in potrošnikov v delo Agencije.
English: The former was delayed due to some performance issues and stability problems.
Slovenian: Pri izvajanju te zbirke so se pojavile zamude zaradi težav z delovanjem in stabilnostjo.
English: The Management Board was notified of the first legal case regarding a paediatric investigation planrelated application.
Slovenian: Upravni odbor je bil obveščen o prvem sodnem postopku v zvezi z izvajanjem načrta pediatričnih raziskav.
English: By the end of the process, the Agency expects to have adopted a formal corporate identity, harmonised the presentation of its communications materials and rationalised its use of document templates.
Slovenian: Nadeja se, da bo ob koncu tega procesa sprejela uradno celostno podobo, uskladila predstavitev svojih komunikacijskih materialov in racionalizirala uporabo predlog dokumentov.
English: Proxy votes from the representatives of France and Luxembourg were given to Belgium, Malta gave its vote by proxy to Cyprus and the United Kingdom gave its vote by proxy to Denmark.
Slovenian: Predstavnika Francije in Luksemburga sta za glasovanje pooblastila Belgijo, Malta je pooblastila Ciper, Združeno kraljestvo pa Dansko.
English: Updated quality policy of the European Medicines Agency [EMEA/MB/355781/2007/Rev.1] The Management Board adopted the updated quality policy, which, among other changes, incorporates references to the revised internal-control standards, and clarifies the separation of audit and integrated-quality-management advice functions.
Slovenian: Posodobljena politika kakovosti Evropske agencije za zdravila [EMEA/MB/355781/2007/Rev.1] Upravni odbor je sprejel posodobljeno politiko kakovosti, med katere spremembami je sklicevanje na revidirane standarde notranjega nadzora, v njej pa je pojasnjena tudi ločitev funkcij revizije in svetovanja za enotno upravljanje kakovosti.
English: The proposed budget is subject to a number of risk factors, including: the difficult global economic climate; the entry into force of the revised variations legislation, which may result in a loss of revenue for the Agency and therefore create the need for an increased Community contribution; revision of the remuneration system for rapporteurships; and risks associated with significant fluctuation of exchange rates.
Slovenian: Predlagani proračun je izpostavljen številnim dejavnikom tveganja, vključno s: težkimi globalnimi gospodarskimi razmerami, začetkom veljavnosti spremenjene zakonodaje s področja sprememb pogojev dovoljenj za promet z zdravili, kar lahko privede do izgube prihodkov Agencije in posledično potrebe po večjem prispevku Skupnosti; pregleda sistema plačevanja nadomestil za poročevalce in tveganj v zvezi z bistvenimi nihanji menjalnih tečajev.
English: Draft agenda for 4-5 March 2009 meeting [EMEA/MB/663707/2008] The agenda was adopted.
Slovenian: Osnutek dnevnega reda za sestanka 4. in 5. marca 2009 [EMEA/MB/663707/2008] Dnevni red je bil sprejet.
English: The Management Board noted the report from the Heads of Medicines Agencies (HMA), which included: information on the election of Johannes Löwer as the new chair of the HMA management group, replacing Jytte Lyngvig; discussions regarding the EudraPharm database; resources of the network; work on antimicrobial resistance.
Slovenian: Upravni odbor se je seznanil s poročilom vodij agencij za zdravila (HMA), ki je zajemalo: informacijo o izvolitvi Johannesa Löwera za novega predsednika upravne skupine HMA, ki je zamenjal Jytte Lyngvig, razprave v zvezi s podatkovno zbirko EudraPharm, mrežne vire in delo na področju protimikrobne odpornosti.
English: The first switch from prescription-only to non-prescription status of a centrally authorised product took place in 2008.
Slovenian: Prvi premik na področju statusa zdravil, ki so pridobila dovoljenje za promet po centraliziranem postopku, od zdravil, ki se izdajajo le na recept, k zdravilom, ki se izdajajo brez recepta, je bil narejen leta 2008.
English: Points for information
Slovenian: Točke v informativne namene
English: Start of the term of office of the Management Board members nominated by the Council [EMEA/MB/87076/2009] The Management Board adopted the decision whereby the term of office of the four members of the Management Board listed in Article 1 of Council Decision No 2009/75/EC commenced on 5 March 2009.
Slovenian: Začetek mandata članov upravnega odbora, ki jih je imenoval Svet [EMEA/MB/87076/2009] Upravni odbor je sprejel sklep, da se je mandat štirih članov upravnega odbora, navedenih v členu 1 Sklepa Sveta št. 2009/75/ES, začel 5. marca 2009.
English: The members noted the update report from the European Commission on a range of topics, including: the guideline setting out what clinical-trial information should be made available to the public; the pharmaceutical package (legislative proposals on pharmacovigilance, tackling counterfeiting of medicines, and information to patients); the evaluation of the EMEA; a recent meeting with Member State representatives on health-technology assessment; the draft Directive on the application of patients' rights with regard to cross-border healthcare; the Commission communication and proposal on patient safety in Europe; and the launch of a public consultation on the future of Europe's workforce for health.
Slovenian: Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno s: smernicami, ki določajo, kateri podatki o kliničnih preskušanjih bi morali biti na voljo javnosti, farmacevtskem svežnju (zakonodajni predlogi o farmakovigilanci, boju proti ponarejanju zdravil in obveščanju bolnikov), vrednotenju agencije EMEA, nedavnem sestanku s predstavniki držav članic o vrednotenju zdravstvene tehnologije, osnutku direktive o izvajanju pravic bolnikov v zvezi s čezmejnim zdravstvenim varstvom, sporočilom in predlogom Komisije o varnosti bolnikov v Evropi ter začetkom javnega posvetovanja o prihodnosti evropskih delavcev v zdravstvu.
English: Some of the deviations of note related to the implementation of the Product Information Management (PIM) and the EU database of clinical trials (EudraCT) projects.
Slovenian: Pri tem je treba upoštevati nekatera odstopanja v zvezi z izvajanjem upravljanja podatkov o zdravilih (PIM) in podatkovne zbirke EU o projektih kliničnih preskušanj (EudraCT).
English: Rules of procedure of the scientific committees:
Slovenian: Poslovniki znanstvenih odborov:
English: Transparency policy
Slovenian: Preglednost
English: Election of the Management Board Vice-chair [EMEA/MB/81623/2009] The Management Board elected Mrs Lisette Tiddens-Engwirda as Vicechair with the following votes: Sole round - 34 votes Lisette Tiddens-Engwirda
Slovenian: Volitve podpredsednika upravnega odbora [EMEA/MB/81623/2009] Upravni odbor je za podpredsednico izvolil Lisette Tiddens-Engwirda z naslednjim številom glasov: Prvi krog - 34 glasov Lisette Tiddens-Engwirda
English: [EMEA/MB/58755/2009] The Management Board also considered the potential financial and budgetary impact of the fee incentives proposed under MUMS/limited markets.
Slovenian: [EMEA/MB/58755/2009] Upravni odbor je obravnaval tudi morebitne finančne in proračunske posledice spodbud za pristojbine, predlaganih v okviru MUMS/omejenih trgov.
English: Preliminary draft work programme 2010
Slovenian: Predhodni osnutek delovnega programa za leto 2010
English: [EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] The Management Board adopted the preliminary draft work programme, budget and staff-policy plan for 2010.
Slovenian: [EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] Upravni odbor je sprejel predhodne osnutke delovnega programa, proračuna in načrta kadrovske politike za leto 2010.
English: The Board nominated Aginus Kalis, Marcus Müllner, Lisette Tiddens and Gro Ramsten Wesenberg as topic coordinators for this project.
Slovenian: Odbor je za tematske koordinatorje tega projekta imenoval Aginusa Kalisa, Marcusa Müllnerja, Lisette Tiddens in Gro Ramsten Wesenberg.
English: The main objectives of the intended new organisation include: integration of the human pre- and postauthorisation (line extensions and variations) procedures; more focus on safety-monitoring of medicines through separation of pharmacovigilance and of risk-management activities from postauthorisation work; creation of a new sector for data management.
Slovenian: Glavni cilji predvidene nove organizacijske ureditve vključujejo: integracijo postopkov pred izdajo dovoljenja za promet (razširitev indikacij in spremembe) z zdravilom za uporabo v humani medicini in po izdaji takega dovoljenja, večji poudarek na spremljanju varnosti zdravil z ločitvijo farmakovigilance in dejavnosti upravljanja tveganj od dejavnosti po izdaji dovoljenja za promet ter oblikovanje novega sektorja za upravljanje podatkov.
English: [EMEA/MB/673201/2008] The Management Board adopted the proposed mandate of the task force, with a deletion of Point 4, relating to future legislative changes.
Slovenian: [EMEA/MB/673201/2008] Upravni odbor je sprejel predlagani mandat projektne skupine ob črtanju točke 4, ki se nanaša na prihodnje spremembe zakonodaje.
English: Revised organisational structure of the EMEA
Slovenian: Spremembe organizacijske strukture agencije EMEA
English: In 2008, the Agency launched a project to review its corporate identity.
Slovenian: Agencija je leta 2008 začela projekt posodobitve svoje celostne podobe.
English: [EMEA/MB/67287/2009] The Management Board endorsed the proposed amendment under paragraph 4.1.4 (MRL applications, including extrapolations) of the procedural advice for classification and incentives for veterinary medicinal products indicated for minor uses and minor species (MUMS)/limited markets.
Slovenian: [EMEA/MB/67287/2009] Upravni odbor je potrdil predlagano spremembo odstavka 4.1.4 (vloge za določanje najvišjih dovoljenih vrednosti ostankov zdravil (MRL), vključno z ekstrapolacijami) postopkovnih mnenj za razvrščanje in spodbude za zdravila za uporabo v veterinarski medicini, namenjena manjši uporabi in manj pomembnim vrstam (MUMS)/omejenim trgom.
English: This work is part of the process-improvement work started in
Slovenian: To delo je del dejavnosti, ki so se začele leta 2006 in so usmerjene k izboljšanju postopkov.
English: [EMEA/118727/2009] The Management Board considered the present state of the discussion on whether the CHMP also has to endorse milestone documents relating to the evaluation of ATMPs.
Slovenian: [EMEA/118727/2009] Upravni odbor je preučil sedanje stanje razprave v zvezi s tem, ali mora tudi odbor CHMP potrditi prelomne dokumente, ki se nanašajo na vrednotenje ATMP.
English: [EMEA/103390/2009] The Management Board noted the ongoing discussion between the CHMP and the CAT regarding the CAT rules of procedure and the procedural advice on evaluation of ATMPs.
Slovenian: [EMEA/103390/2009] Upravni odbor se je seznanil z razpravo, ki poteka med odboroma CHMP in CAT o poslovniku odbora CAT in postopkovnih mnenjih o vrednotenje ATMP.
English: [EMEA/CHMP/89672/2009] The Management Board supported the proposed amendments to the rules of procedure of the CHMP.
Slovenian: [EMEA/CHMP/89672/2009] Upravni odbor je podprl predlagane spremembe poslovnika odbora CHMP.
English: London, 4-5 March 2009
Slovenian: London, 4. in 5. marca 2009
English: Minutes from the 61st meeting, 11 December 2008 [EMEA/MB/671250/2008] The Management Board noted the outcome of the written procedure.
Slovenian: Zapisnik enainšestdesete seje z dne 11. decembra 2008 [EMEA/MB/671250/2008] Upravni odbor se je seznanil z rezultatom pisnega postopka.
English: Minutes of the sixty-second meeting of the Management Board
Slovenian: Zapisnik dvainšestdesete seje upravnega odbora
English: The Chair was notified of each proxy, in writing, in advance of the meeting.
Slovenian: Predsednik je bil o tem pisno obveščen pred sestankom.
English: 5 March 2009 meeting
Slovenian: Sestanek 5. marca 2009
English: Lisette Tiddens-Engwirda
Slovenian: Predstavniki zdravniških Lisette Tiddens-Engwirda organizacij
English: 4 March 2009
Slovenian: 4. marec 2009
English: EMEA/MB/144834/2009/EN/Adopted
Slovenian: EMEA/509555/2009/SL/Sprejeto
English: [EMEA/MB/684002/2008] The Management Board heard a presentation on the implementation of the 2008 work programme.
Slovenian: [EMEA/MB/684002/2008] Upravnemu odboru je bilo predstavljeno izvajanje delovnega programa za leto 2008.
English: Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Slovenian: Gro Ramsten Wesenberg (Norveška)
English: Mike O'Donovan Mary G. Baker
Slovenian: Mike O'Donovan
English: − Preliminary draft budget and establishment plan
Slovenian: Načrtovanje za leto 2010: predhodni osnutek delovnega programa, predhodni osnutek proračuna in načrta delovnih mest, osnutek načrta kadrovske politike.
English: − The Committee for Advanced Therapies (CAT)
Slovenian: Odbora za zdravila za uporabo v humani medicini (CHMP), Odbora za napredno zdravljenje (CAT), osnutek postopkovnih mnenj o vrednotenju zdravil za napredno zdravljenje (ATMP).
English: The Management Board noted the following documents for information: [EMEA/MB/30754/2009] Survey 2008 on the performance of EMEA scientific procedures for medicinal products for human use.
Slovenian: Upravni odbor se je seznanil z naslednjimi dokumenti, predloženimi v vednost: [EMEA/MB/30754/2009] raziskavo o uspešnosti delovanja znanstvenih postopkov agencije EMEA v letu 2008 za zdravila, namenjena uporabi v humani medicini, [EMEA/MB/20870/2009] posodobljenim poročilom o izvajanju telematske strategije EU v agenciji EMEA, [EMEA/86607/2009; EMEA/MB/45112/2009] poročili o izvajanju sistema EudraVigilance za zdravila, namenjena uporabi v humani medicini in veterinarski medicini, [EMEA/MB/81661/2009] rezultatom pisnih postopkov o posvetovanju o spremembah članstva v znanstvenih odborih odborov CHMP in CVMP, [EMEA/MB/649766/2008] povzetkom prerazporeditve proračunskih sredstev za leti 2008 in
English: Sensitive to light.
Slovenian: Občutljivo na svetlobo.
English: In rare cases, the animal may collapse.
Slovenian: V redkih primerih lahko žival kolabira.
English: Do not exceed the stated dose.
Slovenian: Ne prekoračite navedenega odmerka.
English: The intervals between the two administrations should not be less than 3 days or more than 17 days.
Slovenian: Interval dajanja ne sme biti krajši od 3 dni ali daljši od 17 dni.
English: There is no known antidote.
Slovenian: Protistrup ni poznan.
English: The efficacy was tested together with normal management practice.
Slovenian: Učinkovitost so preizkusili skupaj z običajno prakso upravljanja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/193/001-003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/193/001-003
English: These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours.
Slovenian: Ti klinični znaki se običajno pojavijo 30 minut do 2 uri po prvem odmerku in minejo v 2 urah.
English: Bovine No MRL required
Slovenian: Govedo MRL ni potreben
English: ATCvet code: QL03AA90
Slovenian: Oznaka ATC vet: QL03AA90
English: The product may be stored at 25 °C for 24 hours maximum.
Slovenian: Zdravilo lahko pri temperaturi 25 °C hranite največ 24 ur.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/12/2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 09/12/2015
English: Treatment should be symptomatic.
Slovenian: Zdravljenje naj bo simptomatsko.
English: The treatment regimen consists of two syringes.
Slovenian: Režim zdravljenja vključuje dve injekcijski brizgi.
English: The product should only be used on the basis of a positive benefit: risk assessment performed at the herd level by the responsible veterinarian.
Slovenian: Zdravilo uporabite le na podlagi pozitivne ocene razmerja korist/tveganje, ki jo na ravni črede opravi odgovorni veterinar.
English: Shelf -life after first opening the immediate packaging: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: During this EU study, 312 cows were treated with Imrestor for every 10 cases of clinical mastitis that were prevented during the periparturient period.
Slovenian: V tej evropski študiji je 312 krav prejemalo zdravilo Imrestor na vsakih 10 primerov kliničnega mastitisa, ki so bili preprečeni v peripartalnem obdobju.
English: Therapeutic classification
Slovenian: Terapevtske klasifikacije
English: Remove gloves and wash hands and exposed skin after use.
Slovenian: Po uporabi si snemite rokavice ter si umijte roke in izpostavljeno kožo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.7 ml pre-filled syringe contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka 2,7 ml napolnjena injekcijska brizga vsebuje:
English: Available in boxes of 10, 50 or 100 syringes.
Slovenian: Na voljo v škatlah z 10, 50 ali 100 injekcijskimi brizgami.
English: In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094).
Slovenian: V evropski terenski študiji so v skupini, zdravljeni z zdravilom, poročali o 9,1 % pojavnosti kliničnega mastitisa (113/1235), v kontrolni skupini pa o 12,4 % (152/1230), kar kaže na relativno 26,0 % zmanjšanje pojavnosti mastitisa (p=0,0094).
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: In the case of accidental self-injection, headache and bone and muscle pain may occur.
Slovenian: V primeru nenamernega samoinjiciranja se lahko pojavijo glavobol ter bolečine v kosteh in mišicah.
English: The efficacy was tested alongside normal dairy herd management practices.
Slovenian: Učinkovitost so preizkusili skupaj z običajno prakso upravljanja črede.
English: Clinical mastitis is investigated as a change in the appearance of the milk or of the quarter or of both milk and quarter.
Slovenian: Klinični mastitis se ugotavlja kot sprememba v videzu mleka ali vimenski četrti ali obeh (v videzu mleka in vimenski četrti).
English: The content of a single pre-filled syringe is to be injected subcutaneously to a dairy cow/heifer 7 days before the anticipated date of calving.
Slovenian: Vsebina ene napolnjene injekcijske brizge se injicira kravi molznici/telici subkutano 7 dni pred predvidenim datumom telitve.
English: Excessive shaking of the syringe may aggregate pegbovigrastim, reducing its biological activity.
Slovenian: Zaradi pretiranega stresanja injekcijske brizge se lahko pegbovigrastim sprime, s čimer se zmanjša njegova biološka aktivnost.
English: Subcutaneous administration of the product may induce transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment.
Slovenian: Zaradi subkutane uporabe zdravila se lahko na mestu injiciranja pojavi prehodna lokalna oteklina kot tudi vnetne reakcije, ki izzvenijo v 14 dneh po zdravljenju.
English: People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na pegbovigrastim naj se izogibajo stiku z zdravilom.
English: The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu Imrestor 15 mg raztopina za injiciranje za govedo je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010: Farmakološko aktivna snov
English: In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective.
Slovenian: Pri živalih, ki imajo zaradi farmacevtske snovi spremenjeno delovanje imunskega sistema, kot so npr. živali, ki so pred kratkim prejele sistemsko uporabljene kortikosteroide ali nesteroidna protivnetna zdravila, to zdravilo morda ne bo učinkovito.
English: There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticaria and angioedema).
Slovenian: Lahko se pojavijo tudi drugi učinki, vključno s slabostjo, izpuščajem na koži in preobčutljivostnimi reakcijami (težave z dihanjem, hipotenzija, urtikarija in angioedem).
English: Colony stimulating factors regulate the production and functional activities of immune cells.
Slovenian: Faktorji, ki spodbujajo nastajanje kolonij, regulirajo nastajanje in delovanje imunskih celic.
English: Bovine granulocyte colony stimulating factor is a naturally occurring protein produced by mononuclear leukocytes, endothelial cells and fibroblasts.
Slovenian: Faktor, ki spodbuja nastajanje kolonij govejih granulocitov, je naravno prisoten protein, ki ga proizvajajo mononuklearni levkociti, endotelijske celice in fibroblasti.
English: United Kingdom
Slovenian: Združeno kraljestvo ali
English: 2.7 ml of solution for injection in a pre-filled polypropylene colourless syringe with siliconised chlorobutyl stopper and a stainless steel needle with needle guard.
Slovenian: 2,7 ml raztopine za injiciranje v napolnjeni injekcijski brizgi iz brezbarvnega polipropilena z zamaškom iz silikoniziranega klorobutila in z iglo iz nerjavečega jekla z varovalom za iglo.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the pre-filled syringe.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in na napolnjeni injekcijski brizgi.