FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-diphtheria (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.1 IU/ml) Anti-PT (Seroconversion‡‡) (Vaccine response§) Anti-FHA (Seroconversion‡‡) (Vaccine response§)
Danish: Anti-difteri ( 0,1 IE/ml) Anti-tetanus ( 0,1 IE/ml) Anti-PT (Serokonversion‡‡) (Vaccinerespons§) Anti-FHA (Serokonversion‡‡) (Vaccinerespons§)
English: General disorders and administration site conditions Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines.
Danish: Generelle bivirkninger og bivirkninger på injektionsstedet Ødematøs reaktion, der påvirker en eller begge nedre ekstremiteter, kan optræde efter vaccination med vacciner, der indeholder Haemophilus influenzae type b. Hvis denne reaktion optræder, sker det normalt efter primære injektioner og observeres inden for de første få timer efter vaccination.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexacima or a vaccine containing the same components or constituents.
Danish: 6.1, over spor af residualstoffer (glutaraldehyd, formaldehyd, neomycin, streptomycin og polymyxin B), over for en pertussis vaccine, over for en tidligere administration af Hexacima eller en vaccine, der indeholder de samme indholdsstoffer eller bestanddele.
English: Persistence of immune response
Danish: Vedvarende immunrespons
English: At the very least, a booster dose of polio vaccine should be given.
Danish: Som et absolut minimum skal der administreres en booster-dosis af poliovaccine.
English: N=103b
Danish: N=103
English: Hexacima suspension for injection
Danish: Hexacima injektionsvæske, suspension
English: 5 Equivalent antigenic quantity in the vaccine 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Danish: Fremstillet i Hansenula polymorpha gærceller ved hjælp af rekombinant DNA-teknologi
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Danish: Hexacima føres i pakning, der indeholder 1 eller 10 fyldte injektionssprøjter med 2 separate nåle.
English: Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Danish: Data for samtidig administration af rotavirus vacciner har ikke vist nogen klinisk relevant påvirkning af antistofrespons af de enkelte antigener.
English: Without hepatitis B at birth
Danish: Uden hepatitis B ved fødslen
English: STATEMENT OF ACTIVE SUBSTANCE(S) One dose1 (0.5 ml) contains:
Danish: (0,5 ml) indeholder:
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexacima in children over 24 months of age has not been studied in clinical trials.
Danish: Farmakoterapeutisk klassifikation: Vacciner, kombinerede bakterielle og virale vacciner, ATC-kode: J07CA09
English: (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU2
Danish: Difteri toxoid ikke mindre end 20 IE
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Danish: Hexacima føres i pakning, der indeholder 1 eller 10 fyldte injektionssprøjter med 1 separat nål.
English: Hexacima is provided as a suspension for injection in pre-filled syringe (0.5 ml).
Danish: Hexacima foreligger som injektionsvæske, suspension i fyldt injektionssprøjte (0,5 ml).
English: Anti-PRP (≥ 0.15 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Argentina, Mexico, Peru) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration <8 EU/ml, then the post-vaccination antibody concentration should be ≥8 EU/ml.
Danish: * Generelt accepterede surrogater (PT, FHA) eller korrelater for beskyttelse (andre komponenter) N = Antal analyserede individer (per protokolsæt) ** 3, 5 måneder uden hepatitis B-vaccination ved fødslen (Finland, Sverige) † 6, 10, 14 uger med og uden hepatitis B-vaccination ved fødslen (Sydafrika) †† 2, 3, 4 måneder uden hepatitis B-vaccination ved fødslen (Finland) ‡ 2, 4, 6 måneder uden hepatitis B-vaccination ved fødslen (Argentina, Mexico, Peru) og med hepatitis Bvaccination ved fødslen (Costa Rica og Colombia) ‡‡ Serokonversion: minimum 4-folds stigning sammenlignet med niveauet før vaccination (før dosis 1) § Vaccinerespons: Hvis koncentrationen af antistof før vaccination <8 EU/ml, bør antistofkoncentrationen efter vaccination være ≥8 EU/ml.
English: Hexacima is provided as a suspension for injection in vial (0.5 ml).
Danish: Hexacima foreligger som injektionsvæske, suspension i hætteglas (0,5 ml).
English: IM
Danish: NA
English: What you need to know before Hexacima is given to your child
Danish: Det skal du vide, før dit barn vaccineres med Hexacima
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Danish: Difteri, tetanus, pertussis (acellulær, komponent), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus influenzae type b konjugeret vaccine (adsorberet).
English: Anti-Polio type 2 (≥ 8 (1/dilution))
Danish: Anti-polio type 2 ( 8 (1/fortynding))
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth ( Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Danish: * Generelt accepterede surrogater (PT, FHA) eller korrelater for beskyttelse (andre komponenter) N = Antal analyserede individer (per protokolsæt) ** 3, 5 måneder uden hepatitis B-vaccination ved fødslen (Finland, Sverige) † 6, 10, 14 uger med og uden hepatitis B-vaccination ved fødslen (Sydafrika) †† 2, 3, 4 måneder uden hepatitis B-vaccination ved fødslen (Finland) ‡ 2, 4, 6 måneder uden hepatitis B-vaccination ved fødslen (Mexico) og med hepatitis B-vaccination ved fødslen (Costa Rica og Colombia) ‡‡ Serokonversion: minimum 4 gange stigning sammenlignet med niveauet før vaccination (før dosis 1) § Vaccinerespons: Hvis antistofkoncentrationen før vaccination (før dosis 1) er <8 EU/ml, skal antistofkoncentrationen efter booster-vaccination være ≥8 EU/ml, ellers skal antistofkoncentrationen efter booster vaccination være ≥ niveauet før vaccination (før dosis 1).
English: Hexacima in pre-filled syringes
Danish: Hexacima i fyldte injektionssprøjter
English: N=249** N=123 to
Danish: N=123 til
English: Data on concomitant administration of Hexacima with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Danish: Data for samtidig administration af Hexacima med en pneumokok polysaccharid konjugeret vaccine har ikke vist nogen klinisk relevant påvirkning af antistofrespons af de enkelte antigener.
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 IU International Unit
Danish: Adsorberet på aluminiumhydroxid, hydreret (0,6 mg Al IE International enhed
English: 32 D antigen units5
Danish: 32 D antigen-enheder
English: When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexacima or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster.
Danish: Når der gives en hepatitis B-vaccine ved fødslen, kan Hexacima eller en pentavalent DTaP-IPV/HiBvaccine administreres som booster efter en 3-dosis primærvaccination.
English: Anti-Polio type 3 (≥ 8 (1/dilution))
Danish: Anti-polio type 3 ( 8 (1/fortynding))
English: Do not use Hexacima if your child:
Danish: Dit barn må ikke blive vaccineret med Hexacima, hvis det
English: Hexacima in vials 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Danish: Hexacima i hætteglas 0,5 ml injektionsvæske, suspension (type I-glas) med stempelstop (halobutyl).
English: Hypersensitivity reaction
Danish: Ikke almindelig Overfølsomhedsreaktion Sjælden
English: titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
Danish: Immunresponserne på PRP-, PT- og FHA-antigener en måned efter 2 doser, givet ved 2 og 4 måneder, svarede til dem, der blev observeret en måned efter en 2-dosis priming, givet ved 3 og 5 måneder: antiPRP-niveau ≥ 0,15 µg/ml blev observeret hos 73,0 % af individerne, anti-PT-vaccinerespons hos 97,9 % af individerne og anti-FHA vaccinerespons hos 98,6 % af individerne.
English: 8 D antigen units5
Danish: 8 D antigen-enheder
English: • Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (GuillainBarré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
Danish: • Midlertidig inflammation af nerver, der forårsager smerter, lammelse og føleforstyrrelser (Guillain-Barré syndrom) eller alvorlig smerte og formindsket bevægelighed i arm og skulder (brachial neuritis ) er blevet indberettet efter at have fået en vaccine, der indeholder tetanus (en inaktiveret form for stivkrampe).
English: Hepatitis B surface antigen6
Danish: Hepatitis B overfladeantigen
English: In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3%
Danish: Derudover har immunitet mod vaccinens hepatitis B-komponenten vist sig at vare op til 9 år efter en primærvaccination bestående af én dosis af hepatitis B-vaccine givet ved fødslen efterfulgt af en 3dosis børnevaccination ved 2, 4 og 6 månedersalderen uden en børnebooster, hvor 49,3 % af de vaccinerede havde antistoffer ≥ 10 mIE/ml med geometriske middelkoncentrationer på 13,3 (95 % CI: 8,82 til 20,0) mIE/ml.
English: N=322†† N=934 to
Danish: N=322††
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Danish: Difteri, tetanus, pertussis (acellulær, komponent), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus influenzae type b konjugeret vaccine (adsorberet)
English: Data on concomitant administration of a booster dose of Hexacima with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Danish: Data for samtidig administration af en booster dosis af Hexacima med MFR-vacciner har ikke vist nogen klinisk relevant påvirkning af antistofrespons af de enkelte antigener.
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Danish: Respiratoriske lidelser, lidelser i thorax og mediastinum Apnø hos meget præmature spædbørn (≤ 28 ugers svangerskab) (se pkt.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: Fritaget for krav om brailleskrift
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexacima suspension for injection
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)
English: Without hepatitis B vaccination at birth
Danish: Uden hepatitis Bvaccination ved fødsel
English: With hepatitis B vaccination at birth
Danish: Med hepatitis Bvaccination ved fødsel
English: • Swelling of one or both feet and lower limbs which may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and severe crying following vaccination with Haemophilus influenzae type b containing vaccines.
Danish: Dette kan optræde med blåfarvning af huden (cyanose), rødme, små områder med blødning under huden (forbigående blodudtrædninger) og svær gråd efter vaccination indeholdende Haemophilus influenzae type b. Hvis denne reaktion optræder, sker det normalt efter de første injektioner og observeres inden for de første få timer efter vaccination.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 2 separate needles.
Danish: 0,5 ml injektionsvæske, suspension i fyldt injektionssprøjte (type I-glas) med stempelstop (halobutyl) og spidshætte (halobutyl) med 2 separate nåle.
English: Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Danish: Indehaver af markedsføringstilladelsen: Sanofi Pasteur, 14 Espace Henry Vallée, F-69007 Lyon, Frankrig
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 1 separate needle.
Danish: 0,5 ml injektionsvæske, suspension i fyldt injektionssprøjte (type I-glas) med stempelstop (halobutyl) og spidshætte (halobutyl) med 1 separat nål.
English: Keep this vaccine out of the sight and reach of children.
Danish: Denne vaccine skal opbevares utilgængeligt for børn.
English: Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Danish: - Perifer neuropati (polyradiculitis, facialisparase), optisk neurit, centralnervesystems-demyelinisering (multipel sklerose) er indberettet efter administration af vaccine, der indeholder et hepatitis B antigen.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), without needle.
Danish: 0,5 ml injektionsvæske, suspension i fyldt injektionssprøjte (type I-glas) med stempelstop (halobutyl) og spidshætte (halobutyl) uden nål.
English: Anti-diphtheria (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-PTe (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Polio type 1 (≥ 8 (1/dilution))
Danish: Anti-difteri ( 0,01 IE/ml) ( 0,1 IE/ml) Anti-tetanus ( 0,01 IE/ml) ( 0,1 IE/ml) Anti-PT
English: What Hexacima is and what it is used for What you need to know before Hexacima is given to your child How to use Hexacima
Danish: Det skal du vide, før dit barn vaccineres med Hexacima Sådan bliver dit barn vaccineret med Hexacima Bivirkninger
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis du har yderligere spørgsmål om brugen af denne vaccine.
English: Adverse Events
Danish: Bivirkninger
English: MARKETING AUTHORISATION HOLDER Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France
Danish: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Frankrig
English: Pyrexia (body temperature ≥39.6°C)
Danish: Induration på injektionssted Ikke almindelig Knude på injektionssted Pyreksi (legemstemperatur ≥39,6°C)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexacima - Carton for vial.
Danish: Hexacima - Karton til hætteglas.
English: NAd
Danish: ANDET
English: Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon , France
Danish: Sanofi Pasteur, 14 Espace Henry Vallée, F-69007 Lyon, Frankrig
English: What Hexacima looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: This is not considered clinically relevant.
Danish: Dette anses ikke for at være klinisk relevant.
English: Complete response (CR) was evaluated at the end of Block 1.
Danish: Komplet respons (CR) blev evalueret i slutningen af blok 1.
English: This will be done by a healthcare professional.
Danish: Dette vil blive gjort af sundhedspersonalet.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Da dette lægemiddel gives af din læge eller sygeplejerske, er det ikke sandsynligt, at du vil blive givet for meget.
English: Peri- and postnatal development studies were not conducted.
Danish: Peri- og postnatale udviklingsstudier er ikke gennemført.
English: These results, though not mature, constituted the protocol defined final analysis.
Danish: Disse resultater udgjorde, trods det at de ikke var endelige, den protokoldefinerede endelige analyse.
English: Best response
Danish: Bedste respons
English: Day -- -
Danish: Dag -- -
English: Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Danish: Viden om autonom neuropati og dets bidrag til disse uønskede virkninger er begrænset.