natgillin/translations-raw huggingface dataset:
Knogler, led, muskler og bindevæv Almindelig (>1/100, <1/10): led-og muskelsmerter 
Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia
Du kan finde yderligere oplysninger om Foclivia på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Ved bivirkningsovervågning efter markedsføring af adjuverede, interpandemiske, trivalente vacciner med en sammensætning svarende til Foclivia (en MF59C.1-adjuveret pandemisk H1N1-vaccine -) er der rapporteret følgende yderligere bivirkninger: 
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to that of Foclivia (an MF59C.1 adjuvanted H1N1 pandemic vaccines), the following additional adverse reactions have been reported:
MN-resultater mod A/Vietnam/1194/2004 viser en seroprotektion og serokonvertering på henholdsvis 57 % (50-64) til 79 % (68-87) og 55 % (48-62) til 58 % (47-69). 
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
indsnævret SMQ “kramper” 
narrow SMQ “Convulsions”
Anamnese med anafylaktisk (dvs. livstruende) reaktion på ethvert indholdsstof eller spor af æg, hønseproteiner, kanamycin og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB) i denne vaccine. 
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
0,5 ml i enkeltdosis hætteglas (type I-glas) med prop (halobutylgummi). 
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Knogler, led, muskler og bindevæv Muskelsvaghed, ekstremitetssmerter. 
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Flerdosishætteglasset omrystes forsigtigt, før en dosis (0,5 ml) trækkes op i en injektionssprøjte. 
Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Mikroneutraliserings(MN)-resultater mod A/Vietnam/1194/2004 viser en seroprotektionsrate og serokonverteringsrate på henholdsvis 67 % (60-74) til 85 % (78-90) og 65 % (58-72) til 83 % (77-89). 
MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Almindelig (>1/100, <1/10): hovedpine 
Common (>1/100, <1/10): headache
I et fase II klinisk studie (Studie V87P6) blev sikkerheden af en pandemisk adjuveret H5N1-beredskabsvaccine vurderet hos børn og unge (se pkt. 
In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
En oversigt over alle spontane bivirkninger inddelt efter systemorganklasse (SOC), højniveau-term (HLT) og foretrukket term (PT), opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge), herunder antal rapporter med dødsfald, for perioden omfattet af rapporten og kumulativt. 
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.
Antistoffernes persistens efter primær vaccination i denne population vurderet med HI-, SRH- og MN-test faldt fra 1/2 til 1/5 af post-vaccinationsniveauet på dag 202 sammenlignet med dag 43 efter gennemførelse af de primære vaccinationsplaner vurderet med HI-, SRH- og MN-test. Op til 50 % af de ældre forsøgspersoner, der var blevet immuniseret med H5N1-vaccine kombineret med MF59C var serumbeskyttet ved seks måneder. 
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.
Knogler, led, muskler og bindevæv 
tiredness, headache, sweating, pain in muscles and joints.
Almindelig (>1/100, <1/10): led- og muskelsmerter Almene symptomer og reaktioner på administrationsstedet Almindelig (>1/100, <1/10): rødme, hævelse, smerte, ekkymose, induration ved injektionsstedet. 
General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
MN-resultater fra V87P13 gav en GMR mod A/turkey/Turkey/05 på 2,77 (2,4-3,2). 
MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
MN-resultater fra studie V87P13 gav en GMR mod A/turkey/Turkey/05 på 2,77 (2,4-3,2). 
MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 hos forsøgspersoner på over 60 år (et begrænset antal forsøgspersoner var over 70 år) målt med SRH og vurderet i to kliniske studier var som følger: 
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:
Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret) i.m.-injektion i deltamusklen 
Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I.M.
TAL MED LÆGEN, hvis de varer ved. 
If they persist, CONSULT YOUR DOCTOR.
7,5 mikrogram hæmagglutinin 
7.5 micrograms haemagglutinin
5.1 for yderligere information) var de fleste reaktioner lette, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson-influenzavacciner. 
From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Hætteglas, der indeholder 10 doser (hver på 0,5 ml) til injektion. 
It is provided in a vial containing ten doses (0.5 ml each) for injection.
Seroprotektion (95 %CI)* Serokonvertering (95 %CI)* Serokonverteringsfaktor (95 %CI)** * målt med SRH-analyse ≥ 25 mm2 ** geometriske middelværdier for SRH 
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
PT “vaccinationssvigt”. 
PT “Bell's palsy” - Vaccination failure: PT “Vaccination failure”.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL HÆTTEGLAS MED 10 DOSER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 målt med SRH var som følger: 
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Indlægsseddel: Information til brugeren Foclivia injektionsvæske, suspension i fyldt injektionssprøjte 
Package leaflet: Information for the user Foclivia suspension for injection in pre-filled syringe
Alle spontane bivirkninger (SOC, HLT, PT) hos gravide kvinder, opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt. 
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.
MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 11 % (3-25) (studie V87P1) til 30 % (24-37) (studie V87P13) og en serokonvertering på 25 % (19-31) for studie V87P13. 
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.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL HÆTTEGLAS MED 1 DOSIS 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
Alvorlige bivirkninger uden for listen (SOC, HLT, PT'er) opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt. 
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.
Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 hos voksne målt med enkelt radial hæmolyse (SRH-analyse) var som følger: 
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by Single Radial Haemolysis (SRH) assay was as follows:
Seroprotektion (95 % CI)° Serokonvertering (95 % CI)° 
Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Foclivia leveres: i et hætteglas, der indeholder en enkelt dosis (0,5 ml) til injektion. 
It is provided in a vial containing a single dose (0.5 ml) for injection.
MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 27 % (17-39) (V87P1) til 39% (32-46) (V87P13) og en serokonvertering på 36 % (29-43) for V87P13-studiet. 
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 V87P13 study.
Vaccine, der er blevet trukket op i injektionssprøjten, skal opnå stuetemperatur før administration. 
Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
En oversigt over alle spontane bivirkninger opstillet efter aldersgruppe, SOC, HLT og PT, opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt. 
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.
Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/turkey/Turkey/05 efter den 2. dosis hos voksne på 18-60 år målt med SRH- og HI-analyser var som følger: 
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 27 % (17-39) (studie V87P1) til 39% (32-46) (studie V87P13) og en serokonvertering på 36 % (29-43) for studie V87P13. 
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.
Sjælden: (kan forekomme hos 1-10 ud af 10.000 vaccinerede). 
Very rare (may affect up to 1 in 10,000 people).
Almindelig: (kan forekomme hos 1-10 ud af 100 vaccinerede). 
Uncommon: (may affect up to 1 in 100 people).
De øvrige indholdsstoffer er: thiomersal, natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat og vand til injektioner. 
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.
Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/turkey/Turkey/05 efter den 2. dosis hos ældre >60 år målt med SRH- og HI-analyser var som følger: 
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:
Seroprotektion (95 %CI)* Serokonvertering (95 %CI)* Serokonverteringsfaktor (95 %CI)** 
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
De øvrige indholdsstoffer er: natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat og vand til injektioner. 
The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Seroprotektion (95 % CI)* Serokonvertering (95 % CI)* 
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)*
Foclivia injektionsvæske, suspension Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret) 
Foclivia suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Studie V87P1 21 dage efter 2. dosis N=84 
Study V87P1 21 days after 2nd dose N=84
Seroprotektion (95 % CI)* Serokonvertering (95 % CI)* Serokonverteringsfaktor (95 % CI)** 
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)*
Foclivia injektionsvæske, suspension Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) 
Foclivia suspension for injection Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Studie V87P13 21 dage efter 2. dosis N=66 
Study V87P13 21 days after 2nd dose N=66
Studie V87P1 21 dage efter 2. dosis N=70 
Study V87P1 21 days after 2nd dose N=70
Studie V87P13 21 dage efter 2. dosis N=69 
Study V87P13 21 days after 2nd dose N=69
Foclivia injektionsvæske, suspension i flerdosisbeholder Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) 
Foclivia suspension for injection in multidose container Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Studie V87P13 21 dage efter 2. dosis N=128 
Study V87P13 21 days after 2nd dose N=128
Enkeltdosishætteglas: 1 hætteglas, der indeholder en enkelt dosis (0,5 ml) til injektion. 
Single dose vial: 1 vial containing a single dose (0.5 ml) for injection Instructions for administration of the vaccine:
Studie V87P1 21 dage efter 2. dosis N=149 
Study V87P1 21 days after 2nd dose N=149
10 x 10 doser 
10 x 10 doses 1 dose (0.5 ml)
- Frekvensen tages op til overvejelse af indehaveren af markedsføringstilladelsen og (Co-) 
- Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Studie V87P1 21 dage efter 2. dosis N=37 
Study V87P1 21 days after 2nd dose N=37
Studie V87P13 21 dage efter 2. dosis N=210 
Study V87P13 21 days after 2nd dose N=210
Natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, thiomersal, vand til injektioner. 
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, thiomersal, water for injections.
Studie V87P13 21 dage efter 2. dosis N=143 
Study V87P13 21 days after 2nd dose N=143
Studie V87P13 21 dage efter 2. dosis N=207 
Study V87P13 21 days after 2nd dose N=207
- Convulsio: 
- Convulsion:
Foclivia injektionsvæske, suspension i flerdosisbeholder Pandemisk influenzavaccine (overfladeantigener, inaktiveret, adjuveret) 
Foclivia suspension for injection in multidose container Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller hvis du får bivirkninger, som ikke er nævnt her. 
Therefore, tell the doctor or nurse if you fainted with a previous injection.
Foclivia injektionsvæske, suspension i fyldt injektionssprøjte Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) 
Foclivia suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Foclivia injektionsvæske, suspension i fyldt injektionssprøjte Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret) 
Foclivia suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, vand til injektioner. 
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections.
Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Magnesiumchloridhexahydrat Calciumchloriddihydrat Thiomersal 
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Thiomersal,
Kaliumdihydrogenphosphat, Dinatriumphosphatdihydrat, Magnesiumchloridhexahydrat, Calciumchloriddihydrat, Vand til injektionsvæsker. 
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Water for injections.
Enhver anden uønsket hændelse 36 % Unge (9-<18 år) 
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Ikke almindelig: (kan forekomme hos 1-10 ud af 1.000 vaccinerede). 
Rare (may affect up to 1 in 1,000 people).
Natriumcitrat 
Posology
1113 Budapest, Bocskai út 134-146 Ungarn 
AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Hungary
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE 
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norge 
AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
DK-2620 Albertslund, Danmark 
DK-2620 Albertslund, Denmark
AstraZeneca GmbH 22876 Wedel, Tyskland 
AstraZeneca GmbH 22876 Wedel, Germany
Ronda General Mitre, 151 08022 Barcelona, Spanien 
Almirall S.A., Ronda General Mitre, 151 08022 Barcelona, Spain
Grækenland AstraZeneca SA Theotokopoulou 4 & Astronafton 151 25 Maroussi 
AstraZeneca SA Theotokopoulou 4 & Astronafton 151 25 Maroussi Greece
AstraZeneca Österreich GmbH., Schwarzenbergplatz 7, A-1037 Wien, Østrig 
AstraZeneca Österreich GmbH., Schwarzenbergplatz 7, A-1037 Wien, Austria
Palazzo Volta-via F Sforza - 20080 Basiglio (MI) - Italien 
AstraZeneca SpA Palazzo Volta-via F Sforza - 20080 Basiglio (MI)Italy
1, Place Renault 92844 Rueil-Malmaison Cedex Frankrig 
AstraZeneca 1, Place Renault 92844 RueilMalmaison Cedex France
AstraZeneca UK Limited 15 Stanhope Gate London W1K 1LN Storbritannien 
15 Stanhope Gate London W1K 1LN United Kingdom
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, Storbritannien 
Capability Green, Luton, LU1 3LU, United Kingdom
Takeda Pharma GmbH, Viktoriaallee 3-5, 52066 Aachen, Tyskland 
Viktoriaallee 3-5, 52066 Aachen, Germany
Laboratoires Takeda, 11-15, quai de Dion Bouton, 92816 Puteaux Cedex, Frankrig 
Laboratoires Takeda, 11-15, quai de Dion Bouton,
AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, Sverige 
AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, Sweden
AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer Holland 
Netherlands AstraZeneca BV Louis Pasteurlaan 5
AstraZeneca AB 151 85 Södertälje, Sverige 
AstraZeneca AB 151 85 Södertälje, Sweden
Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 
LusomedicamentaSociedade Técnica Farmacêutica, S.A. Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 2730-055 Barcarena, Portugal
AstraZeneca AB, S-151 85 Södertälje, Sverige 
AstraZeneca AB, S151 85 Södertälje, Sweden
Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 
LusomedicamentaSociedade Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso, 69 BQueluz de Baixo 2730-055 Barcarena, Portugal
2730-055 Barcarena, Portugal 
28033 Madrid, Spain
Storbritannien 
United Kingdom.
NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgien 
B-1180 Brussels
AstraZeneca SpA 
AstraZeneca UK Limited
Atacand Plus 32 mg/12.5 mg 
Ratacand Plus 32 mg / 12.5 mg
Atacand Zid 16mg / 12,5 mg 16 mg/12,5 mg Tablet 
Atacand Zid 16mg / 12.5 mg
Atacand Plus 16 mg/12.5 mg 
Atacand Plus 16/12.5 mg
CoKenzen 16mg/12,5mg comprimé 
16mg/12,5mg comprimé
Parapres Plus Forte 32mg/25mg comprimidos 
32mg/25mg comprimidos
Blopress Plus 32mg/ 12,5mg - Tabletten 
Blopress Plus 32mg/ 12,5mgTabletten
Blopress Plus 16mg/12.5mg - Tabletten 
Blopress Plus 16mg/12.5mgTabletten
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hexyon den 17. april 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Hexyon on 17 April 2013.
Hexyon er en vaccine. 
Hexyon is a vaccine.
Den fuldstændige EPAR for Hexyon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Hexyon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Hexyon. 
This is a summary of the European public assessment report (EPAR) for Hexyon.
Vaccination med Hexyon bør foretages i henhold til officielle anbefalinger. 
Vaccination with Hexyon should be carried out according to official recommendations.
Andre oplysninger om Hexyon 
Other information about Hexyon
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hexyon? 
What measures are being taken to ensure the safe and effective use of Hexyon?
Vaccinationsplanen med to doser blev undersøgt i en yderligere hovedundersøgelse hos 554 børn. 
The two-dose vaccination schedule was investigated in an additional main study involving 554 children.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Hexyon opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Hvorfor blev Hexyon godkendt? 
Why is Hexyon approved?
Hexyon indeholder små mængder af materialer, der stammer fra bakterien og virusset, som det beskytter imod. 
Hexyon contains small amounts of materials derived from the bacteria and viruses it protects against.
Det er ikke en praktisk vejledning i, hvordan Hexyon bør anvendes. 
It is not intended to provide practical advice on how to use Hexyon.
Hvad er Hexyon, og hvad anvendes det til? 
What is Hexyon and what is it used for?
Med hensyn til sikkerheden fandt CHMP, at Hexyons sikkerhedsprofil overordnet svarer til andre vacciners, omend der er større sandsynlighed for, at vaccination med Hexyon i forhold til lignende vacciner vil fremkalde reaktioner (hovedsagelig på injektionsstedet). 
Regarding safety, the CHMP considered that Hexyon's overall safety profile is similar to other vaccines, although vaccination with Hexyon is more likely than similar vaccines to cause reactions (mainly at the injection site).