FrancophonIA/ELRC3.0 huggingface dataset:
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Slovenian: Rezultati MN v študiji V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,77 (2,4-3,2).
English: 0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Slovenian: 0,5 ml v viali z enkratnim odmerkom (steklo vrste I) z zamaškom (iz halobutilne gume).
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows:
Slovenian: Stopnja serozaščite*, delež serokonverzije* in faktor serokonverzije** za protitelesa proti HA na H5N1 A/turkey/Turkey/05 po 2. odmerku pri starejših, starih > 60 let, izmerjeni s testi SRH in HI, so bili, kot sledi:
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Slovenian: Zvišana telesna temperatura ≥ 40 °C Vsi drugi neželeni učinki
English: - Active substance:
Slovenian: - Pomožne snovi:
English: Rare (may affect up to 1 in 1,000 people).
Slovenian: Redki (se lahko pojavijo pri največ 1 cepljeni osebi od 1.000 cepljenih oseb).
English: What is n this leaflet:
Slovenian: Kaj vsebuje navodilo
English: While no data is available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia.
Slovenian: Čeprav podatkov o uporabi zdravila Foclivia ni, so pri osebah, ki so prejele zdravilo Focetria (cepivo proti pandemični gripi H1N1, ki vsebuje adjuvans MF59.1 in je podobno zdravilu Focetria), ugotovili primere konvulzij z zvišano telesno temperaturo in brez nje.
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Slovenian: Napolnjena injekcijska brizga, ki vsebuje enkratni odmerek (0,5 ml) za injiciranje.
English: An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Slovenian: Pregled vseh spontanih neželenih učinkov po organskih sistemih (OS), izrazih na visoki ravni (High Level Term - HLT) in prednostnih izrazih (PI), stratificirani glede na vrsto poročila (medicinsko potrjeno ali nemedicinsko potrjeno) z vključitvijo števila fatalnih poročil za obdobje, ki ga krije poročilo, in kumulativno.
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects.
Slovenian: V 3-tedenskem presledku so 156 preiskovancev cepili s cepivom, ki je vsebovalo H5N1 (A/Vietnam/1194/2004; 7,5 µg hemaglutinina (HA)/odmerek z adjuvansom).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA VIALO Z ENIM ODMERKOM
English: Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Slovenian: Pred vsakim odvzemom odmerka (0,5 ml) cepiva v brizgo previdno pretresite večodmerno vialo.
English: Two doses of vaccine containing H9N2 (A/chicken/Hong Kong/G9/97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/dose), were administered four weeks apart.
Slovenian: V presledku 4 tednov so pri 4 različnih odmerkih (3,75; 7,5; 15 in 30 μg HA/odmerek) uporabili dva odmerka cepiva, ki je vsebovalo sev H9N2 (A/Chicken/Hong Kong/G9/97).
English: 0.66 milligrams
Slovenian: 0,66 miligramov citronska kislina
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13.
Slovenian: A/turkey/Turkey/05 v razponu od 27 % (17-39) (V87P1) do 39 % (32-46) (V87P13) in stopnjo serokonverzije 36 % (29-43) za študijo V87P13.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
Slovenian: H5N1 A/Vietnam/1194/2004 pri preiskovancih, starejših od 60 let (omejeno število preiskovancev je bilo starejših od 70 let), izmerjeni s testom SRH in ocenjeni v dveh kliničnih študijah, so bili, kot sledi:
English: A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137).
Slovenian: MF59C.1 (n = 334), s sezonskim cepivom proti gripi (n = 137).
English: 7.5 micrograms haemagglutinin
Slovenian: 7,5 mikrogramov hemaglutinina
English: Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Slovenian: Stopnja serozaščite (95-odstotni IZ)° Delež serokonverzije (95-odstotni IZ)°
English: A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Slovenian: Pri 312 zdravih odraslih prostovoljcih so izvedli klinično preskušanje 2. faze (študija V87P1) s kombinacijo cepiva H5N1 in adjuvansa MF59C.1.
English: CHMP immunogenicity criteria set for adults (18-60 years) were met both after the 1st and the 2nd dose in all the above age strata (both in the overall population and in the subset seronegative at baseline).
Slovenian: V vseh navedenih starostnih skupinah (v celotni populaciji in v podskupini v izhodišču seronegativnih oseb) so bili po prvem in drugem odmerku doseženi kriteriji CHMP za imunogenost za odrasle (18-60 let).
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13.
Slovenian: A/turkey/Turkey/05 v razponu od 11 % (3-25) (študija V87P1) do 30 % (24-37) (študija V87P13) in stopnjo serokonverzije 25 % (19-31) za študijo V87P13.
English: Package leaflet: Information for the user Foclivia suspension for injection in multidose container
Slovenian: Foclivia suspenzija za injiciranje v vsebniku z več odmerki.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATIONS TO COMPLETE POST AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: It is provided in a vial containing a single dose (0.5 ml) for injection.
Slovenian: Na voljo je v vialah, ki vsebujejo enkratni odmerek (0,5 ml) za injiciranje.
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Slovenian: 11 mesecev, in 73 malčkih, starih 12-35 mesecev, ki so prejeli formulacijo 7,5 µg, so bili, kot sledi:
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Slovenian: V primerjavi z ravnmi protiteles, pridobljenimi 43. dan po zaključku primarnega režima cepljenja, so bile ravni protiteles 202. dan zmanjšane od 1/5 do 1/2 glede na predhodne ravni, izmerjene s testi HI, SRH in MN. Do 50 % starejših oseb, imuniziranih s cepivom proti H5N1 z dodanim MF59C, je bilo v šestem mesecu serozaščitenih.
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Slovenian: Hudi nenavedeni neželeni učinki (OS, HLT, PI), stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
English: Common (may affect up to 1 in 10 people).
Slovenian: Pogosti (se lahko pojavijo pri največ 1 cepljeni osebi od 10 cepljenih oseb).
English: All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Slovenian: Vsi spontani neželeni učinki (OS, HLT, PI) pri nosečnicah, stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Slovenian: Vsi spontani neželeni učinki glede na starostno skupino po OS, HLT in PI, stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
English: You should discuss with your doctor whether you should receive Foclivia.
Slovenian: O cepljenju z zdravilom FOCLIVIA se posvetujte z zdravnikom.
English: Uncommon: (may affect up to 1 in 100 people).
Slovenian: Občasni (se lahko pojavijo pri največ 1 cepljeni osebi od 100 cepljenih oseb).
English: It is provided in a vial containing ten doses (0.5 ml each) for injection.
Slovenian: Viala vsebuje 10 odmerkov (0,5 ml na odmerek) za injiciranje.
English: Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I.M.
Slovenian: cepivo proti pandemični gripi (površinski antigeni, inaktivirani, z adjuvansom)
English: Baseline Serostatus
Slovenian: Serostatus ob izhodišču
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Slovenian: Delež serokonverzije (95-odstotni IZ)* Faktor serokonverzije (95-odstotni IZ)**
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Slovenian: OVOJNINAH OZNAKA ZA VIALO Z DESETIMI ODMERKI
English: Therefore, tell the doctor or nurse if you fainted with a previous injection.
Slovenian: če ste omedleli pri kakšnem prejšnjem injiciranju.
English: Study V87P1 21 days after 2nd dose N=84
Slovenian: Študija V87P1 21. dan po 2. odmerku n = 84
English: Study V87P13 21 days after 2nd dose N=66
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 66
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Slovenian: Pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktičnih reakcij) na učinkovino, katero koli pomožno snov, navedeno v poglavju 6.1, in na jajca, piščančje beljakovine,
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Slovenian: Zdravnik mora te osebe (ali starše) obvestiti o možnosti konvulzij (glejte poglavje 4.8).
English: Study V87P1 21 days after 2nd dose N=70
Slovenian: Študija V87P1 21. dan po 2. odmerku n = 70
English: Milky-white liquid.
Slovenian: Guillain-Barréjev sindrom.
English: Study V87P13 21 days after 2nd dose N=128
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 128
English: OTHER
Slovenian: OKOLIŠČINAH
English: Study V87P13 21 days after 2nd dose N=69
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 69
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE AND 1-DOSE VIAL
Slovenian: OVOJNINAH OZNAKA ZA BRIZGO IN VIALO Z ENIM ODMERKOM
English: Foclivia suspension for injection Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Slovenian: Foclivia suspenzija za injiciranje cepivo proti pandemični gripi (H5N1) (površinski antigen, inaktiviran, z adjuvansom)
English: Study V87P1 21 days after 2nd dose N=37
Slovenian: Študija V87P1 21. dan po 2. odmerku n = 37
English: Study V87P13 21 days after 2nd dose N=197
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 197
English: Study V87P13 21 days after 2nd dose N=210
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 210
English: Study V87P1 21 days after 2nd dose N=149
Slovenian: Študija V87P1 21. dan po 2. odmerku n = 149
English: Foclivia suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Slovenian: Foclivia suspenzija za injiciranje cepivo proti pandemični gripi (površinski antigeni, inaktivirani, z adjuvansom)
English: Study V87P13 21 days after 2nd dose N=207
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 207
English: General disorders and administration site conditions Asthenia.
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija
English: Study V87P13 21 days after 2nd dose N=143
Slovenian: Študija V87P13 21. dan po 2. odmerku n = 143
English: Foclivia suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Slovenian: Foclivia suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti pandemični gripi (površinski antigeni, inaktivirani, z adjuvansom)
English: A clinical trial (study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Slovenian: Neželeni učinki iz kliničnih preskušanj pri otrocih, starih od 6 mesecev do 17 let V kliničnem preskušanju (študija V87P6) so primerjali cepivo H5N1, kombinirano z adjuvansom
English: Foclivia suspension for injection in multidose container Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Slovenian: Foclivia suspenzija za injiciranje v vsebniku z več odmerki cepivo proti pandemični gripi (H5N1) (površinski antigen, inaktiviran, z adjuvansom)
English: Foclivia suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Slovenian: Foclivia suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti pandemični gripi (H5N1) (površinski antigen, inaktiviran, z adjuvansom)
English: Single dose vial: 1 vial containing a single dose (0.5 ml) for injection Instructions for administration of the vaccine:
Slovenian: Viala z enkratnim odmerkom: 1 viala, ki vsebuje enkratni odmerek (0,5 ml) za injiciranje.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Slovenian: angioedem Bolezni prebavil prebavne bolezni, vključno z navzeo, bruhanjem, trebušne bolečine in driska Bolezni živčevja glavobol, omotica, somnolenca, sinkopa.
English: Foclivia contains Thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Zdravilo Foclivia vsebuje tiomersal kot konzervans.
English: The other ingredients are: thiomersal, sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Slovenian: Pomožne snovi so tiomersal, natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat in voda za injekcije.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, thiomersal, water for injections.
Slovenian: Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, tiomersal, voda za injekcije.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.
Slovenian: Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, voda za injekcije.
English: Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Foclivia injection
Slovenian: suspenzija za injiciranje Viala
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Slovenian: Pomožne snovi so natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat in voda za injekcije.
English: You should discuss with your doctor whether you should receive FOCLIVIA The vaccine may be used during lactation.
Slovenian: O cepljenju z zdravilom Foclivia se posvetujte z zdravnikom.
English: AESIs will be defined as follows:
Slovenian: single radial haemolysis), so bili, kot sledi:
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, ZDRAVILA, POTI UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET V DRŽAVAH ČLANICAH
English: 2719 EE Zoetermeer The Netherlands
Slovenian: 2719 EE Zoetermeer Nizozemska
English: Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London,
Slovenian: Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych,
English: AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Hungary
Slovenian: Madžarska AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Madžarska
English: Netherlands AstraZeneca BV Louis Pasteurlaan 5
Slovenian: Nizozemska AstraZeneca BV Louis Pasteurlaan 5
English: DK-2620 Albertslund, Denmark
Slovenian: DK-2620 Albertslund, Danska
English: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
Slovenian: Norveška AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo,
English: Takeda UK Limited, Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Buckinghamshire HP10 OHH United Kingdom.
Slovenian: Takeda UK Limited, Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Buckinghamshire HP10 OHH
English: AstraZeneca SA Theotokopoulou 4 & Astronafton 151 25 Maroussi Greece
Slovenian: Theotokopoulou 4 & Astronafton 151 25 Maroussi Grčija
English: Almirall S.A., Ronda General Mitre, 151 08022 Barcelona, Spain
Slovenian: Ronda General Mitre, 151 08022 Barcelona, Španija
English: AstraZeneca GmbH 22876 Wedel, Germany
Slovenian: AstraZeneca GmbH 22876 Wedel, Nemčija
English: AstraZeneca SpA Palazzo Volta-via F Sforza - 20080 Basiglio (MI)Italy
Slovenian: Palazzo Volta-via F Sforza - 20080 Basiglio (MI) - Italija
English: AstraZeneca Österreich GmbH., Schwarzenbergplatz 7, A-1037 Wien, Austria
Slovenian: AstraZeneca Österreich GmbH., Schwarzenbergplatz 7, A-1037 Wien,
English: Takeda Italia Farmaceutici S.p.A., Via Elio Vittorini, 129 00144 Roma Italy
Slovenian: Takeda Italia Farmaceutici S.p.A., Via Elio Vittorini, 129
English: AstraZeneca 1, Place Renault 92844 RueilMalmaison Cedex France
Slovenian: 1, Place Renault 92844 Rueil-Malmaison Cedex Francija
English: AstraZeneca A/S Roskildevej 22, DK2620 Albertslund, Denmark
Slovenian: AstraZeneca A/S Roskildevej 22, DK-2620 Albertslund, Danska
English: Takeda Pharma Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Slovenian: Takeda Pharma Ges.m.b.H., Seidengasse 33-35, 1070 Wien,
English: Czech Republic AstraZeneca UK Ltd., Macclesfield, Cheshire, United Kingdom
Slovenian: AstraZeneca UK Ltd., Macclesfield, Cheshire,
English: WC2B 4AE, United Kingdom
Slovenian: London,WC2B 4AE, Velika Britanija
English: 15 Stanhope Gate London W1K 1LN United Kingdom
Slovenian: London W1K 1LN
English: Atacand Plus
Slovenian: Atacand Plus Mite
English: Capability Green, Luton, LU1 3LU, United Kingdom
Slovenian: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, Velika Britanija
English: Viktoriaallee 3-5, 52066 Aachen, Germany
Slovenian: Takeda Pharma GmbH, Viktoriaallee 3-5, 52066 Aachen, Nemčija
English: Laboratoires Takeda, 11-15, quai de Dion Bouton,
Slovenian: Laboratoires Takeda, 11-15, quai de Dion Bouton, 92816 Puteaux Cedex, Francija
English: AstraZeneca UK Limited
Slovenian: Slovenija AstraZeneca UK Limited 15 Stanhope Gate
English: LusomedicamentaSociedade Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 2730-055 Barcarena, Portugal
Slovenian: Portugalska Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso, 69 BQueluz de Baixo
English: Rua Humberto Madeira, 7, Queluz de Baixo 2730-097 Barcarena, Portugal
Slovenian: Rua Humberto Madeira, 7, Queluz de Baixo
English: 28033 Madrid, Spain
Slovenian: 2730-097 Barcarena, Portugalska
English: AstraZeneca AB 151 85 Södertälje, Sweden
Slovenian: AstraZeneca AB 151 85 Södertälje, Švedska
English: B-1180 Brussels
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgija
English: AstraZeneca AB, S151 85 Södertälje, Sweden
Slovenian: AstraZeneca AB, S-151 85 Södertälje, Švedska
English: Atacand Zid 16mg / 12.5 mg
Slovenian: Atacand Zid 16mg / 12.5 mg 16 mg / 12.5 mg
English: Ratacand Plus 32 mg / 12.5 mg
Slovenian: Atacand Plus 32 mg/12.5 mg
English: 16mg/12,5mg comprimé
Slovenian: CoKenzen 16mg/12,5mg comprimé
English: AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, Sweden
Slovenian: AstraZeneca AB, S-151 85 Södertälje, švedska
English: CoKenzen
Slovenian: AstraZeneca
English: Ratacand Plus 32 mg / 25 mg
Slovenian: Atacand Plus Forte 32 mg/25 mg
English: 32mg/25mg comprimidos
Slovenian: Parapres Plus Forte 32mg/25mg comprimidos
English: Hytacand 16 mg 16 mg / 12.5 mg
Slovenian: Atacand Plus 16 mg/12.5 mg 16 mg / 12.5 mg
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexyon on 17 April 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Hexyon, veljavno po vsej Evropski uniji, izdala 17. aprila 2013.
English: What measures are being taken to ensure the safe and effective use of Hexyon?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hexyon?
English: Other information about Hexyon
Slovenian: Druge informacije o zdravilu Hexyon
English: The full EPAR for Hexyon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hexyon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vaccination with Hexyon should be carried out according to official recommendations.
Slovenian: Cepljenje s cepivom Hexyon je treba izvajati v skladu z uradnimi priporočili.
English: This is a summary of the European public assessment report (EPAR) for Hexyon.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hexyon.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexyon's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hexyon večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Hexyon is a vaccine.
Slovenian: Zdravilo Hexyon je cepivo.