FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually
Slovenian: Po cepljenju se trajanje imunosti na homologne seve ali na seve, ki so tesno povezani s sevi cepiva, razlikuje, običajno pa traja od 6 do 12 mesecev.
English: Other vaccines or medicines and IDflu Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: - If you have an illness with fever or acute infection, the vaccination shall be postponed until
Slovenian: - če imate bolezen s povišano telesno temperaturo ali akutno okužbo, morate cepljenje prestaviti na kasnejše obdobje, ko si opomorete.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Slovenian: Preobčutljivost na zdravilno učinkovino, na katero koli pomožno snov navedeno v poglavju 6.1 ali na katere izmed naslednjih sledov: jajc (ovalbumin, piščančje beljakovine), neomicina, formaldehida in
English: Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain.
Slovenian: Zelo pogosti (lahko prizadanejo več kot 1 med 10 cepljenimi) - Na mestu injiciranja: pordelost, otrdelost, otekanje, srbenje in bolečina.
English: (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
Slovenian: - Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
English: ** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
Slovenian: ** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4-povečanje titra HI po cepljenju
English: IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Slovenian: Cepivo ID flu je tako imunogeno kot primerjalno trivalentno cepivo z adjuvansom (ki vsebuje MF-59) v smislu GMT za vsakega od 3 sevov gripe po metodi SRH in za 2 seva po metodi HI.
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Slovenian: Cepiva IDflu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: - Other vaccines: IDflu can be given at the same time as other vaccines by using separate limbs.
Slovenian: - Druga cepiva: cepivo IDflu se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
English: IDflu should under no circumstances be administered intravascularly.
Slovenian: Cepivo IDflu se pod nobenim pogojem ne sme dajati intravaskularno.
English: This vaccine is intended for individuals 60 years of age and over.
Slovenian: To cepivo uporabljajo starejši od 60 let.
English: The active substances are Influenza virus (inactivated split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
Slovenian: A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09 ............................................................................................................................. 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) ............................................................................................................................. 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............ 15 mikrogramov HA**
English: Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Slovenian: Neznani Alergijska reakcija, ki vključuje generalizirano kožno reakcijo kot je urtikaria, anafilaktično reakcijo, angioedem, šok
English: 4/ INJECT USING THE INDEX FINGER
Slovenian: 4/ INJICIRAJTE S KAZALCEM
English: IDflu is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
Slovenian: Pediatrična populacija Uporaba zdravila IDflu zaradi pomanjkljivih podatkov o varnosti in učinkovitosti ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: Posology Individuals 60 years of age and over: 0.1 ml.
Slovenian: Odmerjanje Odrasli starejši od 60 let: 0,1 ml.
English: With the same hand, push very firmly with the thumb on the plunger to activate the You hear a click and a shield comes out to cover the needle.
Slovenian: Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
English: Intradermal 15µg A/H3N2
Slovenian: Intradermalno 15 µg
English: 1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System
Slovenian: 1 napolnjena brizga (0,1 ml) z mikro-injekcijskim sistemom 10 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom 20 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom
English: The recommended site of administration is the region of the deltoid.
Slovenian: Priporočeno mesto cepljenja je predel deltoidne mišice.
English: In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not
Slovenian: V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno cepljenje ni potrebno.
English: IDflu is a vaccine.This vaccine is recommended to help to protect you against flu.
Slovenian: Cepivo se priporoča za zaščito proti gripi.
English: In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Slovenian: V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite*, serokonverzijo ali značilne stopnje povečanja** in razmerje geometričnega povprečja titrov (GMTR)
English: In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Slovenian: V randomiziranih primerjalnih preskušanjih faze III je 2606 oseb, starih nad 60 let, prejelo 0,1 ml cepiva IDflu intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0,5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
English: IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of
Slovenian: Cepivo IDflu je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih nad 60 let.
English: Interference with serological testing: See section 4.5.
Slovenian: Interferenca s serološkimi testi: glejte poglavje 4.5. 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Justification for not including Braille is accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications.
Slovenian: Cepivo se lahko daje odraslim starejšim od 60 let, še zlasti tistim, pri katerih obstaja povečano
English: Immunisation shall be postponed in subjects with febrile illness or acute infection.
Slovenian: Imunizacijo pri osebah s povišano telesno temperaturo ali akutno okužbo je treba preložiti.
English: Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Slovenian: Zaščita proti gripi pri odraslih starejših od 60 let, še zlasti tistih, pri katerih obstaja povečano tveganje
English: MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
English: • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Slovenian: • Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo (1,5 mm) in s sistemom za zaščito igle.
English: Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
Slovenian: - Alergijske reakcije, vključno kožne reakcije, ki se lahko razširijo po vsem telesu kot izpuščaji, hude alergijske reakcije (anafilaktične reakcije) otekel obraz, jezik ali žrelo, težave pri požiranju, koprivnica in oteženo dihanje (angioedem), okvare obtočil (šok ), zaradi katerih je
English: In some cases, redness at the injection site lasted up to 7 days.
Slovenian: V posameznih primerih lahko ostane rdečina na mestu vboda do 7 dni.
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Slovenian: V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva IDflu intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku
English: • The vaccine should be allowed to reach room temperature before use.
Slovenian: • Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
English: This vaccine has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
English: • Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
Slovenian: • bolečine na živčnih poteh, konvulzije, povezane s povišano telesno temperaturo, bolezni živčevja, vključno z vnetjem možganov ali hrbtenjače, vnetjem živcev ali Guillain-Barréjev sindrom, ki povzroča izjemno utrujenost in paralizo.
English: Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
Slovenian: ), stopnje serozaščite med 48,9% in 87,9%, serokonverzija ali značilne stopnje povečanja med 30,0% in 46,9% in GMTR med 3,04 in 5,35 krat nad izhodiščem
English: - Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
Slovenian: kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
Slovenian: PODATKI NA ZUNANJI OVOJNINI Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
English: Common reactions (may affect up to 1 in 10 people) - Bruising at the injection site.
Slovenian: Pogosti (lahko prizadanejo do 1 med 10 cepljenimi) - Modrica na mestu injiciranja
English: IDflu will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Slovenian: Po injiciranju cepiva IDflu razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi z Cepivo IDflu pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
English: • The vaccine should not be used if foreign particles are present in the suspension.
Slovenian: • Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti.
English: 4.5 Interaction with other medicinal products and other forms of interaction IDflu may be given at the same time as other vaccines.
Slovenian: Zdravilo IDflu se lahko daje sočasno z drugimi cepivi.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Slovenian: Če se bolnik zdravi z imunosupresivnimi zdravili, je imunski odziv lahko manjši.
English: The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Slovenian: Pomožne snovi so: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen
English: Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré
Slovenian: Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain-Barréjev sindrom Žilne bolezni vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
English: The following side effects have been reported with other vaccines given to prevent flu.
Slovenian: V povezavi z drugimi cepivi proti gripi so poročali o naslednjih neželenih učinkih Neželeni učinki, ki
English: The recommended dose is 0.1 ml for individuals 60 years of age and over.
Slovenian: Priporočeni odmerek za drasle, starejše od 60 let je 0,1 ml.
English: IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Slovenian: IDflu 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
English: Transient thrombocytopenia, transient lymphadenopathy
Slovenian: Bolezni krvi in limfatičnega sistema prehodna trombocitopenija, prehodna limfadenopatija
English: - You should tell your doctor before vaccination if you have a poor immune response
Slovenian: - Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv,
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom s farmacevtom ali z
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom ali z
English: 0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
Slovenian: opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
English: Always use this vaccine exactly as your doctor or pharmacist has told you.
Slovenian: Pri uporabi tega cepiva natančno upoštevajte napotke v tem navodilu ali navodila svojega zdravnika ali farmacevta.
English: Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Slovenian: A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju (glejte poglavje 4.8).
English: • Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Slovenian: (ovalbumin, piščančje beljakovine), neomicin, formaldehid in oktoksinol 9.
English: • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: • Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju
English: 5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER
Slovenian: 5/ S ČVRSTIM PRITISKOM NA BAT AKTIVIRAJTE ZAŠČITO IGLE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
Slovenian: OVOJNINAH Besedilo na nalepki za napolnjeno brizgo
English: NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Slovenian: Navodilo za uporabo: informacije za uporabnika IDflu 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in
Slovenian: Zdravilo IDflu je suspenzija za injiciranje v napolnjenih injekcijskih brizgah z 0,1 ml s sistemom za mikro-injiciranje, pakirana po 1, 10 ali 20 enot.
English: Therefore, this information is not
Slovenian: Navedba zato smiselno ni potrebna.
English: Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: The vaccine should not be used if foreign particles are present in the suspension.
Slovenian: Če so v raztopini prisotni tujki, cepiva ne smete uporabiti.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
English: Talk to your doctor, pharmacist or nurse before using IDflu.
Slovenian: Pred začetkom uporabe cepiva IDflu se posvetujte s svojim zdravnikom, farmacevtom ali z medicinsko sestro.
English: Common Uncommon Rare
Slovenian: Prirobni ca
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. RUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Paediatric population
Slovenian: Otroci in mladostniki
English: NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated) Strains 2016/2017
Slovenian: IDflu 15 mikrogramov/sev, suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
English: Injection is considered successful whether or not the presence of a wheal is In case of presence of liquid at the injection site after vaccine administration, re
Slovenian: Injekcija je uspešna ne glede na prisotnost izpuščaja.
English: The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Slovenian: Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo
English: 15 µg haemagglutinin per strain per 0.1 ml dose
Slovenian: 15 mikrogramov hemaglutinina na sev na 0,1 ml odmerek natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat, voda za
English: IDflu is administered to you by your doctor or nurse.
Slovenian: Cepivom IDflu vam bo dal vaš zdravnik.
English: Cattle and Sheep
Slovenian: Govedo in ovce
English: * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Slovenian: * Relativna potenca (test potence na miših) v primerjavi z referenčnim cepivom, ki je bilo dokazano učinkovito pri ciljnih živalskih vrstah.
English: Vial (HDPE) 50 ml
Slovenian: Viala (HDPE) 50 ml
English: Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Slovenian: Inaktivirani virus Scmallenberg, sev BH80/11-4: ≥ 1 RP*/2 ml (za krave) ali ≥ 1 RP* /ml (za ovce).
English: EU/2/14/178/001 Zulvac SBV --1 Suspension for injection
Slovenian: EU/2/14/178/001 Zulvac SBV
English: Intramuscular use or subcutaneous use.
Slovenian: Intramuskularna uporaba ali subkutana uporaba
English: Zero days
Slovenian: 1 viala 0 dni
English: The Agency issued its opinion on 17 October 2019.
Slovenian: Agencija je mnenje izdala 17. oktobra 2019.
English: The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Slovenian: Podjetje, ki je zaprosilo za dovoljenje, Daiichi Sankyo Europe GmbH, lahko v 15 dneh od prejema mnenja zahteva ponovni pregled mnenja.
English: 18 October 2019 EMA/559309/2019 EMEA/H/C/004468
Slovenian: 18. oktober 2019 EMA/559309/2019 EMEA/H/C/004468
English: Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Slovenian: Več informacij o določitvi zdravila sirote je voljo na spletišču agencije: ema.europa.eu/medicines/human/orphan-designations/eu309622.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Slovenian: Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki sodeluje v kliničnem preskušanju.
English: What were the main reasons for refusing the marketing authorisation?
Slovenian: Kateri so bili glavni razlogi za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom?