FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the CHMP considered that there were concerns regarding the long-term antibody persistence, the adequacy of the safety data set in the light of the CHMP Guideline on Clinical Evaluation of New Vaccines, and the indication of Menitorix for both priming and boosting.
Danish: CHMP vurderede imidlertid, at der var problemer med den langsigtede persistens af antistoffer, om sikkerhedsdatasættet var tilstrækkeligt i lyset af CHMP's retningslinjer for klinisk vurdering af nye vacciner og med Menitorix' indikation til såvel priming som boosting.
English: There were no significant differences between the two groups in the proportions with SBA-MenC titers of at least 1:8 or anti-PRP antibody concentrations of at least 0.15 µg/ml.
Danish: Der var ingen signifikant forskel mellem de to gruppers andelen af en SBAMenC-titer på mindst 1:8 eller en anti-PRP-antistofkoncentrationer på mindst 0,15 mikrogram/ml.
English: It is recommended that infants who receive Menitorix for the first dose should also receive this vaccine for the second and third doses of the primary vaccination course.
Danish: Det anbefales at børn, som får Menitorix ved 1. vaccination i det primære vaccinationsprogram, også får denne vaccine ved 2. og 3. vaccination.
English: Menitorix is a freeze-dried vaccine preparation consisting of 5µg of the purified H. influenzae type b capsular polysaccharide, polyribosylribitol phosphate (PRP) and 5µg of the meningococcal capsular polysaccharide of group C (PSC) both directly conjugated to tetanus toxoid (TT) carrier protein.
Danish: Menitorix er et frysetørret vaccinepræparat, som består af 5µg renset H. influenzae type b kapsulær polysaccharid, polyribosylribitolfosfat (PRP) og 5µg meningokok kapsulær polysaccharid af gruppe C (PSC), begge direkte konjugeret til tetanustoksoid (TT) transportørprotein.
English: The CHMP considered that the data suggests that the likely long term protection afforded by Menitorix should not be a cause for concern when used for priming and boosting or for boosting children primed with other MenC conjugate vaccines.
Danish: CHMP vurderede, at dataene tyder på, at Menitorix' sandsynlige langsigtede beskyttelse ikke bør give anledning til bekymring ved brug til priming og boosting eller til boosting hos børn, som har fået priming med andre MenC-konjugatvacciner.
English: Tell the doctor or nurse immediately if your child develops a rash (which may be raised or lumpy), tightness of the throat, swelling of the face or neck or shortness of breath.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis dit barn får hududslæt (som også kan være en hævelse eller en bule), forsnævring i halsen, hævelser i ansigtet eller halsen eller åndenød.
English: • if your child takes medicines or has any treatment which may affect the immune system.
Danish: • hvis dit barn får anden medicin eller behandling, som påvirker kroppens naturlige forsvarssystem (immunsystem).
English: Although Menitorix contains tetanus toxoid (inactivated bacterial toxin), which is used to immunise people against tetanus (lockjaw), it is still necessary that your child should receive the recommended childhood vaccinations against tetanus.
Danish: Selvom Menitorix indeholder inaktiveret bakteriegiftstof (inaktiveret tetanustoksin), som bruges til at øge forsvarssystemmet mod stivkrampe, er det nødvendigt, at dit barn får de anbefalede børnevacciner mod stivkrampe.
English: • if your child has a bleeding problem or bruises easily.
Danish: • hvis dit barn let får blå mærker eller unormale blødninger.
English: Menitorix has been used in UK since September 2006 and three 6-monthly PSURs have been issued to date, with reassuringly low reporting rates and no new safety concerns allowing the Applicant/MAH to conclude that the safety profile is adequately reflected in the Core Safety Information.
Danish: Menitorix har været anvendt i Storbritannien siden september 2006, og der er til dato udsendt tre halvårlige PSUR med beroligende lave rapporteringstal og ingen nye sikkerhedsmæssige problemer.
English: The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
Danish: Vaccinen skal injiceres med forsigtighed til personer med trombocytopeni eller en bløderforstyrrelse.
English: The data from SPCs, literature and generated during clinical development combined with recent surveillance data from the United Kingdom and Canada suggest that vaccine effectiveness remained high in unprimed subjects who had been vaccinated in their second year of life with a single dose.
Danish: Data fra produktresuméer, faglitteratur og data, som er genereret under den kliniske udvikling kombineret med nye overvågningsdata fra Storbritannien og Canada, tyder på, at vaccinens effektivitet forblev høj hos personer, hvor effekten af vaccinen ikke var igangsat (priming), men som i deres andet leveår var blevet vaccineret med en enkelt dosis.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Danish: En udredning af anamnesen (specielt med hensyn til tidligere vaccinationer og forekommende bivirkninger) og en klinisk undersøgelse bør foretages inden vaccination.
English: The referral procedure was initiated with UK as the reference member state (RMS), due to concerns raised by the concerned member states Greece, Poland and Spain regarding major safety and efficacy issues and the immunological protection correlates, they considered the submitted clinical documentation insufficient to establish the clinical efficacy and safety of Menitorix, considering the product to be an entirely new conjugated, bivalent vaccine.
Danish: På grund af betænkeligheder hos de berørte medlemsstater Grækenland, Polen og Spanien vedrørende store problemer med sikkerhed og effekt og de immunologiske beskyttelseskorrelater betragtede de den indsendte kliniske dokumentation som utilstrækkelig til at fastslå klinisk effekt og sikkerhed for Menitorix og betragtede produktet som en helt ny konjugeret, bivalent vaccine.
English: • Haemophilus influenzae type b (Hib): Hib bacteria most frequently cause meningitis (inflammation of the coverings of the brain and spinal cord).
Danish: • Haemophilus influenzae type b (Hib): Hib-bakterier giver oftest meningitis (betændelse i hjernehinden eller rygmarvshinden).
English: Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Danish: Fortæl det altid til lægen, hvis dit barn bruger anden medicin, har brugt det for nylig, eller for nylig er blevet vaccineret med en anden vaccine.
English: Overall, 92.7% of 177 subjects had SBA-MenC titres of at least 1:8 and 99.4% of the 178 subjects had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Danish: I alt havde 92,7 % af de 177 børn en SBA-MenC titre på mindst 1:8, og 99,4 % af de 178 børn havde en anti-PRPantistofkoncentration på mindst 0,15 mikrogram/ml.
English: Menitorix is available in packs of 1 or 10 with 2 separate needles or without needles.
Danish: Menitorix leveres i pakningsstørrelserne 1 eller 10, med eller uden 2 kanyler.
English: GMC (micrograms/ml)
Danish: GMC (mikrogram/ml)
English: Each dose of Menitorix is a single injection of half a millilitre (0.5 ml).
Danish: Hver dosis Menitorix er en enkelt vaccination på ½ ml (0,5 ml).
English: In one of these trials, the incidences of adverse reactions observed in subjects (N=102) who received Menitorix concomitantly with MMR* were similar to those observed in the group who received MMR alone (N=91) or Menitorix alone (N=104).
Danish: I det ene af disse forsøg var hyppigheden af bivirkninger, observeret for personer (N = 102), som modtog Menitorix samtidig med MFR* vaccine sammenlignelig med dem, som blev observeret i den gruppe, som kun modtog MFR-vaccine (N = 91), eller som kun modtog Menitorix (N = 104) (se pkt.
English: The safety and immunogenicity data provided are adequate to establish that the risk-benefit relationship for the use of Menitorix for priming in infancy and/or boosting in the second year of life is favourable.
Danish: De udleverede sikkerheds- og immunogenicitetsdata er tilstrækkelige til at kunne fastlægge, at der er et gunstigt risk/benefit-forhold ved anvendelse af Menitorix til priming hos spædbørn og/eller boosting i det andet leveår.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 dosis
English: Antibody levels have been measured at 18 months after the administration of a booster dose of Menitorix at age 14 Months to subjects who had been primed in infancy with either Menitorix at 2, 4 and 6 months of age or with NeisVac-C at 2, 4 months of age (and a DTPa/Hib containing vaccine at 2, 4, 6 months of age).
Danish: Antistofniveauet blev målt 18 måneder efter administration af Menitorix boosterdosis hos 14-månder gamle børn, som tidligere var blevet eksponeret for enten Menitorix ved 2-, 4- og 6-måneders alderen eller NeisVac-C ved 2-, 4-måneders alderen (og en DTPa/Hib vaccine ved 2-, 4-, 6-måneders alderen).
English: After three doses N=330†
Danish: Efter tre doser N = 330†
English: The Company has already planned to assess long-term antibody persistence and, to complete this procedure, should formally commit to providing to the relevant national competent authorities for assessment the data from longer-term follow-up of studies 010/022 and 013 with anticipated timelines.
Danish: For at afslutte denne procedure skal virksomheden formelt forpligte sig til at forsyne de relevante lokale, kompetente myndigheder med data til bedømmelse fra de mere langsigtede opfølgningsundersøgelser 010/022 og 013 med forventet tidsplan.
English: When Menitorix was administered as a 3-dose primary vaccination course, a DTPaHBV-IPV* vaccine (N=796) or a DTPa-IPV vaccine* (N=375) was administered concomitantly.
Danish: Samtidig med, at Menitorix blev administreret i et 3-dosisprimærvaccinationsprogram, blev en DTPa-HBV-IPV* vaccine (N = 796) eller en DTPa-IPV vaccine* (N = 375) også givet.
English: Booster vaccination
Danish: Boostervaccination
English: Menitorix can be used to boost protection in children who received Menitorix previously or in children who previously received other vaccines against these diseases (including children who received two doses of a MenC vaccine in early life).
Danish: Menitorix kan gives som boostervaccine til langtidsbeskyttelse af børn, som tidligere har fået Menitorix, eller til børn, som tidligere har fået andre vacciner mod disse sygdomme (inklusive børn som tidligere har fået to vaccinationer med en MenC vaccine).
English: Inject the entire contents of the vial.
Danish: Injicer hele indholdet af hætteglasset.
English: If you have previously been told by your doctor that your child suffers from nephrotic syndrome (a kidney disease which may result in swelling, particularly around the face or eyes, protein in the urine making it appear frothy and/or weight gain) there may be an increased chance that this condition will reoccur within a few months after vaccination.
Danish: Hvis du tidligere har fået at vide, at dit barn lider af nyresygdommen nefrotisk syndrom, er der øget risiko for, at denne tilstand vil komme igen inden for få måneder efter vaccination (Nefrotisk syndrom resulterer i hævelser især i ansigtet og omkring øjnene, proteiner i urinen, hvilket gør urinen skummende, og/eller vægtøgning) Fortæl lægen, hvis dit barn får lignende symptomer efter vaccinationen.
English: MenC PSC - Neisseria meningitidis serogroup C polysaccharide
Danish: MenC PSC - Neisseria meningitis serogruppe C polysaccharid
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: 10 x 1 dose (0.5 ml)
Danish: 10 x 1 dosis (0,5 ml)
English: A single (0.5 ml) dose of Menitorix may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series with Menitorix or with other Hib or MenC conjugate vaccines.
Danish: En enkelt (0,5 ml) dosis Menitorix kan bruges til at booste immuniteten for Hib og MenC hos børn, som tidligere har fuldendt et primært vaccinationsprogram med Menitorix eller andre Hib eller MenC konjugerede vacciner.
English: (see also sections 4.4 and 4.5)
Danish: 4.4 og 4.5)
English: * Hib PRP - Haemophilus influenzae type B polyribosylribitol phosphate TT - tetanus toxoid
Danish: * Hib PRP - Haemophilus influenzae type B polyribosylribitolphosphat TT - tetanustoksin
English: If it is not used within 24 hours, it should be discarded.
Danish: Såfremt den rekonstituerede vaccine ikke er brugt inden for 24 timer, skal den kasseres.
English: If Menitorix is used in infants for the first vaccinations against Hib and MenC:
Danish: Hvis Menitorix gives til børn som første vaccination mod Hib og MenC:
English: Neisseria meningitidis serogroup C (strain C11) polysaccharide
Danish: Neisseria meningitis serogruppe C (stamme C11) polysaccharid
English: In three clinical trials (N=209), 92.3% of subjects had an SBA-MenC titre ≥ 1/8 at 11-18 months of age, i.e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
Danish: I tre kliniske forsøg (N = 209) havde 92,3 % af børnene en SBA-MenC titer ≥ 1/8 ved 11-18måneders alderen, det vil sige 7-14 måneder efter afslutningen af 3-dosis-primærprogrammet med Menitorix.
English: Common (≥1/100, <1/10)
Danish: Almindelig (≥ 1/100 til, < 1/10)
English: It is usual to wait until the child is better before giving the vaccine.
Danish: Vaccinationen vil sædvanligvis blive udsat til barnet har det bedre.
English: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Danish: Haemophilus type b-polysaccharid (polyribosylribitolphosphat)
English: Subjects primed with 3 doses of Meningitec + Pediacel N= 115
Danish: Børn eksponeret med 3 doser af Meningitec + Pediacel N = 115
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Symptomer på en overfølsomhedsreaktion kan være kløende hududslæt, åndenød og hævelse af ansigt eller tunge.
English: The new totals are therefore 3293 infants vaccinated with Menitorix either as a primary course or as a booster and 578 infants vaccinated with 1713 doses of closely related Hib-MenC formulations.
Danish: De nye, samlede tal er derfor 3293 spædbørn vaccineret med Menitorix enten som en primær vaccination eller som booster og 578 spædbørn vaccineret med 1713 doser nært beslægtede Hib-MenC-formuleringer.
English: In the group primed with NeisVac-C 115/121 (95%) had SBA-MenC titers of at least 1:8 and 121/122 (99.2%) had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Danish: I den gruppe, som blev eksponeret med NeisVac-C som primærvaccination, havde 115/121 (95 %) en SBAMenC titer på mindst 1:8 og 121/122 (99,2 %) havde en anti-PRP-antistofkoncentration på mindst 0,15 mikrogram/ml.
English: BEFORE YOUR CHILD RECEIVES MENITORIX
Danish: Hvis dit barn har fået for meget Menitorix
English: Nervous system disorders: very common: drowsiness
Danish: Nervesystemet Meget almindelig: Sløvhed
English: Trometamol Sucrose
Danish: Trometamol Saccharose
English: What Menitorix is and what it is used for Before your child receives Menitorix How Menitorix is given Possible side effects
Danish: Menitorix' virkning og hvad du skal bruge det til Det skal du vide, før dit barn vaccineres med Menitorix Sådan skal du bruge Menitorix Bivirkninger
English: Subjects primed with 2 doses of NeisVac-C** N=167
Danish: Børn eksponeret med 2 doser af NeisVac-C** N = 167
English: Menitorix should not be given:
Danish: Menitorix indeholder:
English: ♦ Uncommon (in less than 1 per 100 but more than 1 per 1,000 doses of vaccine)
Danish: ♦ Ikke almindelig (det sker ved mindre en 1 ud af 100, men ved flere end 1 ud af 1000 vaccinationer)
English: Overall, the CHMP considers the safety database to be of adequate size and satisfactory in content, supporting the use of Menitorix for priming in infancy and for boosting children in the second year of life who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
Danish: Samlet set vurderer CHMP, at sikkerhedsdatabasen er af passende størrelse og med tilfredsstillende indhold, og at den understøtter brugen af Menitorix til priming hos spædbørn og boosting i det andet leveår hos børn, som har fået priming med Menitorix eller andre Hib- og MenC-konjugatvacciner.
English: Long-term immunogenicity data following the use of Menitorix as a primary and booster vaccination are not yet available (see section 5.1).
Danish: Immunogenisitetsdata efter længere tids anvendelse af Menitorix som primær- og boostervaccination er endnu ikke tilgængelige.
English: Powder and solvent for solution for injection White powder and a clear colourless solvent.
Danish: Hvidt pulver og klar farveløs solvens.
English: Haemophilus type b and Meningococcal group C conjugate vaccine
Danish: Konjugeret Haemophilus type b- og Meningokok gruppe C-vaccine
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Powder: trometamol, sucrose
Danish: Pulver: Trometamol, saccharose.
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml rSBA-MenC
Danish: Anti-PRP-antistoffer mikrogram/ml mikrogram/ml GMC (mikrogram/ml) rSBA-MenC
English: Severe skin reactions, collapse or shock-like state (hypotonic-hyporesponsiveness episode), faints, seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia, relapse of nephrotic syndrome, arthralgia, petechiae and/or purpura.
Danish: Alvorlige hudreaktioner, kollaps eller shocktilstand, besvimelsesanfald, kramper hos personer, som i forvejen lider af krampeanfald, hypoæstesi, paræstesi, tilbagefald af nefrotisk syndrom, artralgi, petecchie og/eller purpura.
English: In various studies with licensed monovalent meningococcal group C conjugate vaccines, concomitant administration with combinations containing diphtheria, tetanus and acellular pertussis components (with or without inactivated polio viruses, hepatitis B surface antigen or Hib conjugate [e.g. DTPaHBV-IPV-Hib*]), has been shown to result in lower serum bactericidal antibody (SBA) geometric mean titres (GMT) compared to separate administrations or to co-administration with whole cell pertussis vaccines.
Danish: Forskellige forsøg med godkendte, konjugerede monovalente meningokokker gruppe C-vacciner, som er administreret sammen med kombinationsvacciner indeholdende difteri-, tetanus- og acellulær pertussiskomponenter (med og uden inaktiveret polio virus, hepatitis B overflade antigen eller konjugeret Hib [f.eks. DTPa-HBV-IPV-Hib*]), har vist at give lavere geometriske gennemsnitstitre (GMT) for serumbakerielt antistof (SBA) sammenlignet med separat administration eller administration i kombination med helcellepertussis-vaccine.
English: (See sections 4.5 and 5.1)
Danish: 4.5 og 5.1)
English: The vaccine cannot cause Hib and MenC.
Danish: Vaccinen giver ikke i sig selv Hib og MenC.
English: Responses to all the co-administered antigens were satisfactory and were similar to those achieved in control groups that received DTPa-HBV-IPV-Hib* concomitantly with a MenC conjugate vaccine (MenCC) or DTPa-HBV-IPV* concomitantly with a Hib conjugate vaccine and no MenCC.
Danish: Responset for alle samtidigt administrerede antigener var tilfredstillende og sammenlignelige med det opnåede respons i kontrolgrupperne, som fik DTPaHBV-IPV-Hib* samtidig med en konjugeret MenC-vaccine (MenCC) eller DTPa-HBV-IPV* samtidig med en Hib konjugeret vaccine og ingen MenCC.
English: Hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients (see sections 2 and 6.1).
Danish: Overfølsomhed over for de aktive stoffer, tetanustoksin eller over for nogle af hjælpestofferne (se pkt.
English: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom
Danish: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS England
English: ≥0.15 micrograms/ml ≥1 micrograms/ml
Danish: ≥ 0,15 mikrogram/ml ≥ 1 mikrogram/ml
English: 10 vials: Powder 10 pre-filled syringes: Solvent 10 x 1 dose (0.5 ml)
Danish: 10 hætteglas: Pulver 10 fyldte injektionssprøjter: Solvens 10 x 1 dosis (0,5 ml)
English: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
Danish: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, England
English: There are no data available on the use of Menitorix in infants who were born prematurely.
Danish: Der er ingen data tilgængelig for administration af Menitorix til for tidligt fødte børn.
English: Allergic reactions (these can be recognised by itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing), swelling of the glands, dizziness, convulsions (fits) with high temperature, unusual muscle slackness, headache.
Danish: Overfølsomhedsreaktioner (som kan være kløende hududslæt på hænder og fødder, hævelse omkring øjne og i ansigtet, åndenød eller besvær med at synke), hævelser af kirtler, svimmelhed, feberkramper, muskelslaphed, hovedpine.
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Danish: Meget sjælden (≥ 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data) I hver frekvensgruppe er bivirkningerne listet med faldende alvorlighed.
English: In two clinical trials (N=578), Menitorix was administered concomitantly with Measles, Mumps, Rubella (MMR) vaccine.
Danish: I to kliniske forsøg (N = 578), blev Menitorix administreret samtidig med en mæslinge-, fåresyge- og røde-hunde-vaccine (MFR).
English: If you miss an appointment, it is very important that you contact the surgery or clinic and make a new appointment for your child to have the missed dose or doses as soon as possible.
Danish: Hvis du glemmer at komme til den aftalte tid, er det meget vigtigt, at du hurtigst mulig kontakter konsultationen eller klinikken og får aftalt en ny tid til vaccination af dit barn.
English: Antibody persistence has been demonstrated for Hib in three clinical trials (N=217) with 98.2% of subjects having an anti-PRP concentration of ≥ 0.15 microgramsml at 11-18 months of age i.e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
Danish: Vedholdende antistof er eftervist for Hib i tre klinsiske forsøg (N = 217), hvor 98,2 % af børnene havde en anti-PRP-koncentration på ≥ 0,15 mikrogram/ml ved 11-18-måneders alderen, det vil sige 714 måneder efter afslutningen af 3-dosis-primærprogrammet med Menitorix.
English: The data support the use of Menitorix for priming in infancy and for boosting in the second year of life and for boosting toddlers who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
Danish: Dataene understøtter brugen af Menitorix til priming hos spædbørn og til boosting i det andet leveår samt til boosting af små børn, som har fået priming med Menitorix eller med andre Hib- og MenC-konjugatvacciner.