FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder in a vial (type I glass) with a stopper (butyl rubber), 0.5 ml of solvent in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) with or without separate needles in the following pack sizes: - pack size of 1 vial of powder plus 1 pre-filled syringe of solvent with 2 separate needles or without needles - pack size of 10 vials of powder plus 10 pre-filled syringes of solvent with 2 separate needles or without needles
Danish: Pulver i hætteglas (type I-glas) med en prop (butyl-gummi), 0,5 ml solvens i fyldt injektionssprøjte (type I-glas) med en stempelprop (butyl-gummi) med eller uden separate kanyler i følgende pakningsstørrelser: - 1 hætteglas med pulver og 1 fyldt injektionssprøjte med solvens, med eller uden 2 separate kanyler.
English: The immune response to the Hib and MenC components of Menitorix was only assessed in primary vaccination clinical studies that employed co-administration with DTPa-IPV* or DTPa-HBV-IPV* vaccines.
Danish: Immunresponset for Hib og MenC komponenterne i Menitorix er kun vurderet i kliniske forsøg med primær vaccination med samtidig administration af DTPa-IPV* eller DTPa-HBV-IPV* vacciner.
English: Menitorix can be given at the same time as vaccines intended to protect against one or more of diphtheria, tetanus, whooping cough, polio, hepatitis B, pneumococcal conjugate vaccine and combined vaccines against measles, mumps and rubella (MMR).
Danish: Menitorix kan anvendes samtidig med en eller flere vacciner til beskyttelse mod difteri, stivkrampe, kighoste, polio og hepatitis B, samt med konjugerede pneumokok-vacciner.
English: Primary vaccination history
Danish: Primær vaccination
English: There are no data on the use of Menitorix for one or two doses of the primary vaccination course and other Hib and/or MenC conjugate vaccines for other dose(s).
Danish: Der findes ingen data for anvendelsen af Menitorix ved 1. og 2. vaccination i det primære vaccinationsprogram og derefter en anden Hib og/eller konjugeret MenC-vaccine ved efterfølgende vaccinationer.
English: Menitorix can be used to boost toddlers primed with this vaccine or with other licensed Hib and MenC conjugate vaccines.
Danish: Menitorix kan anvendes til boosting af små børn, som har fået priming med denne vaccine eller andre godkendte Hib- og MenC-konjugatvacciner.
English: After three doses N=111
Danish: efter tre doser N = 111
English: The reconstituted vaccine is a clear and colourless solution.Inject the entire contents of the vial.
Danish: Den rekonstituerede vaccine er en klar og farveløs opløsning.
English: However, following several reports of suspected ADRs, section 4.8 of the Menitorix SPC was updated.
Danish: Afsnit 4.8 i produktresuméet for Menitorix er imidlertid ajourført efter flere rapporter om mistanke om bivirkninger.
English: The total safety database derived from clinical studies now consists of 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 and therefore exceeds that suggested by the CHMP Guideline for truly new vaccines.
Danish: Den totale sikkerhedsdatabase fra de kliniske undersøgelser består nu af 3293 spædbørn, som er vaccineret med Menitorix enten som primær vaccination eller som booster, og 578 spædbørn vaccineret med 1713 doser nært beslægtede Hib-MenC-formuleringer.
English: No data are available on the use of Menitorix in immunodeficient subjects.
Danish: Der er ingen data tilgængelig for administration af Menitorix til børn med immundefekt.
English: The nurse or doctor will give Menitorix as an injection into the muscle (usually into the thigh muscle but in toddlers the arm muscle can be used) and will make sure that the vaccine is not given into a blood vessel or into the upper layer of the skin.
Danish: Sygeplejersken eller lægen vil give Menitorix som en indsprøjtning i en muskel (normalt i lårmusklen, eller for småbørn i musklen i armen).
English: Also, Menitorix can only protect against meningitis and other infections caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Danish: Menitorix kan kun beskytte mod meningitis og betændelse, som skyldes bakterierne Haemophilus influenzae tybe b (Hib) og Neisseria meningitis gruppe C (MenC).
English: 10 vials: Powder 10 pre-filled syringes: Solvent 20 Needles
Danish: 10 hætteglas: Pulver 10 fyldte injektionssprøjter: Solvens 20 kanyler
English: In a trial of booster vaccination against Hib and MenC, Menitorix was administered concomitantly (into opposite thighs) with a first dose of combined measles, mumps and rubella (MMR) vaccine.
Danish: I et forsøg med boostervaccination mod Hib og MenC, blev Menitorix administreret samtidig (på hver sit lår) med 1. dosis af en kombineret mæslinge-, fåresyge- og røde hunde- (MFR) vaccine.
English: In the Menitorix primed and boosted group 49/56 (87.5%) of the subjects had SBA-MenC titers of at least 1:8 and 56/56 (100%) had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Danish: I den gruppe, som blev eksponeret med Menitorix både som primærvaccination og boostervaccination, havde 49/56 (87,5 %) en SBA-MenC titer på mindst 1:8, og 56/56 (100 %) havde en antistofkoncentration på mindst 0,15 mikrogram/ml.
English: • if your child has previously had any allergic reaction to Menitorix, to any Hib or MenC vaccine, to tetanus toxoid or to any other ingredient present in the vaccine (see section 6).
Danish: • hvis dit barn tidligere har haft en overfølsomhedsreaktion (allergi) over for Menitorix, over for andre Hib eller MenC vacciner, over for giftstoffet fra bakterien, som medfører stivkrampe
English: A minor infection such as a cold should not be a problem but talk to your doctor or nurse first.
Danish: En mindre infektion som forkølelse bør ikke give problemer.
English: Belgium GlaxoSmithkline Biologicals S.A., 89 rue de l'Institut, B-1330 Rixensart, Belgium
Danish: GlaxoSmithkline Biologicals S.A., 89 rue de l'Institut, B-1330
English: In clinical trials of primary vaccination series, Menitorix was administered concomitantly (into opposite thighs) with a DTPa-HBV-IPV vaccine.
Danish: I kliniske forsøg med de primære vaccinationsprogrammer blev Menitorix administreret samtidig (på hver sit lår) med en DTPa-HBV-IPV vaccine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml) contains: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Efter rekonstitution indeholder hver dosis (0,5 ml): Haemophilus type b-polysaccharid (polyribosylribitolphosphat)
English: Subjects primed with 3 doses of Menitorix* N= 349
Danish: Børn eksponeret med 3 doser af Menitorix* N = 349
English: Powder and solvent for solution for injection 1 vial: Powder
Danish: Pulver og solvens til injektionsvæske, opløsning 1 hætteglas: Pulver
English: Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000)
Danish: Sjælden (≥ 1/10.000 til, < 1/1.000)
English: Take special care with Menitorix:
Danish: Vær ekstra forsigtig med at tage Menitorix
English: The product is used for the active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) and is administered by intramuscular injection.
Danish: Produktet anvendes til aktiv immunisering af spædbørn fra 2-månedersalderen og små børn op til 2 år til forebyggelse af invasive sygdomme forårsaget af Haemophilus influenzae type b (Hib) og Neisseria meningitidis gruppe C (MenC) og administreres via intramuskulær injektion.
English: After two doses N=93
Danish: Antistof efter to doser N = 93
English: 1 pre-filled syringe: Solvent 1 dose (0.5 ml)
Danish: 1 fyldt injektionssprøjte: Solvens 1 dosis (0,5 ml)
English: What Menitorix looks like and contents of the pack Menitorix is supplied as a white powder of Hib-MenC vaccine in a glass vial, together with half a millilitre (0.5 ml) of clear colourless sodium chloride solvent in a pre-filled syringe for a 1 dose vaccine.
Danish: En dosis Menitorix leveres i et hætteglas med Hib-MenC som et hvidt pulver sammen med ½ ml (0,5 ml) klar, farveløs natiumchlorid-opløsning i en fyldt injektionssprøjte.
English: The following adverse events have been reported after administration of Menitorix: Allergic reactions (including urticaria and anaphylactoid reactions), lymphadenopathy, dizziness, febrile seizures, hypotonia, headache.
Danish: Allergiske reaktioner (inklusive nældefeber og anafylaktiske reaktioner), lymfeknudesvulst, svimmelhed, feberkramper, hypotoni, hovedpine.
English: This powder is dissolved in the solvent provided, just before injection.
Danish: Pulveret skal opsløses i den medfølgende væske umidelbart før injektion.
English: Menitorix will only confer protection against Haemophilus influenzae type b and Neisseria meningitidis group C. As for any vaccine, Menitorix may not completely protect against the infections it is intended to prevent in every vaccinated individual There are no data available on administration of Menitorix in toddlers not already primed with Hib and MenC conjugates.
Danish: Menitorix vil kun give beskyttelse mod Haemophilus influenzae type b og Neisseria meningitis gruppe C. Som for alle andre vacciner, giver Menitorix ikke fuldstændig beskyttelse hos alle de vaccinerede personer.
English: Gastrointestinal disorders: very common: appetite lost uncommon: diarrhoea, vomiting
Danish: Meget almindelig: Appetitløshed Ikke almindelig: diaré, opkasting
English: The following information is intended for medical or healthcare professionals only: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration.
Danish: 6.6 Regler for destruktion og anden håndtering Den rekonstituerede vaccine skal undersøges visuelt for partikler og/eller variation i fysiske forhold inden administration.
English: Your child can still be given Menitorix if your doctor or nurse advises it but your child may not develop as good protection against Hib and MenC infections as other children.
Danish: Disse børn kan på lægens eller sygeplejerskens opfordring godt blive vaccineret med Menitorix, men det er muligt at beskyttelsen mod betændelse af Hib- og MenCbakterier ikke er så god som hos raske børn.
English: powder and solvent for solution for injection intramuscular injection
Danish: Pulver og solvens til injektionsvæske, opløsning
English: Subjects primed with 3 doses of Menitorix* N=123
Danish: Børn eksponeret med 3 doser af Menitorix* N = 123
English: In order to further justify the adequacy of the safety database in children primed and/or boosted with Menitorix, the Applicant/MAH provided additional data from two recently reported studies, augmenting the total database with an additional 1131 subjects who received a total of 2992 doses of Menitorix.
Danish: For yderligere at retfærdiggøre, at sikkerhedsdatabasen over børn, som har fået priming eller boosting med Menitorix, er tilstrækkelig, udleverede ansøgeren/indehaveren af markedsføringstilladelsen yderligere data fra to nylige undersøgelsesrapporter.
English: HOW TO STORE MENITORIX
Danish: SÅDAN SKAL DU BRUGE MENITORIX
English: There are no data on concomitant use of Menitorix with whole cell pertussis and oral poliomyelitis vaccines, however, no interference is expected.
Danish: Der er ingen data for samtidig administration af Menitorix med helcellepertussis og oral poliomyelitisvacciner.
English: Subjects primed with 3 doses of Meningitec** or Menjugate** N=96
Danish: Børn eksponeret med 3 doser af Meningitec** eller Menjugate** N = 96
English: Read the package leaflet before use Shake well before use
Danish: Intramuskulær anvendelse Læs indlægssedlen inden brug Omrystes før brug
English: Menitorix is a vaccine that can be given to children after the age of 2 months up to 2 years to prevent infectious diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria.
Danish: Menitorix er en vaccine, som kan gives til børn i alderen fra 2 måneder og op til 2 år, til forebyggelse af smitsomme sygedomme, som skyldes bakterierne Haemophilus influenzae type b (Hib) og Neisseria meningitis gruppe C (MenC).
English: They include: Collapse or shock, the child not responding to his or her parents for a time after vaccination, fainting, convulsions in children who have had them before, lack of sensation or an increased sensation (for example pain, pins and needles or itching at the injection site), joint pain, or purple spots or patches under the skin.
Danish: Andre bivirkninger, som meget sjældent er set (set ved mindre end 1 ud af 10000 vaccinationer) hos børn, som har fået andre vacciner indeholdende MenC: Kollaps eller chok, at barnet efter vaccinationen ikke reagerer på kontakt fra forældrene, besvimelse, feberkramper eller kramper hos børn, som tidligere har haft kramper, nedsat eller øget følesans (f.eks. smerter, sovende legemsdele eller kløen ved indsprøjningsstedet), ledsmerter, eller blå/violette pletter eller områder under huden.
English: Based on - the Rapporteur's and Co-Rapporteur's assessment reports, - the Applicant/MAH response to the CHMP questions, - the Scientific discussion within the Committee,
Danish: - bedømmelsesrapporten fra rapportøren og medrapportøren - ansøgerens/indehaveren af markedsføringstilladelsens svar på spørgsmål fra CHMP - den faglige drøftelse i udvalget anbefalede CHMP udstedelse af markedsføringstilladelse for Menitorix med ændringer i de relevante afsnit af patientinformationen og med forpligtelser, som skal opfyldes.
English: Not relevant.
Danish: som ikke er nævnt her.
English: Using other medicines or vaccines
Danish: Brug af anden medicin
English: Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
Danish: Børn eksponeret med 3 doser af godkendt Meningitec** eller Menjugate** N = 96
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen [Se Bilag I - Udfyldes nationalt]
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
Danish: Procentdelen af børn med en antistoftitre ≥ ”assay cut-off” en måned efter boostervaccination med Menitorix administreret samtidig med en mæslinge-fåresyge-røde-hunde-vaccine (MFR)* var følgende:
English: Menitorix is not recommended for use in children above 2 years of age due to a lack of data on safety and efficacy.
Danish: På grund af manglende data for sikkerhed og effekt bør Menitorix ikke bruges til børn over 2 år.
English: If your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or confusion, or red or purple bruise-like spots that do not fade under pressure you should contact your doctor or local accident and emergency department immediately to rule out other causes.
Danish: Hvis dit barn får et af følgende symptomer, skal du straks kontakte din læge eller nærmeste skadestue for at få undersøgt dit barn: Nakkesmerter, nakkestivhed eller modvilje mod lys, bliver sløv eller konfus, får røde eller blålige mærker, som ikke falmer ved tryk.
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
Danish: Procentdelen af børn med antistoftitre ≥ ”assay cut off” en måned efter primærvaccination med Menitorix givet samtidig med en DTPa-IPV*- eller DTPa-HBV-IPV*-vaccine var følgende:
English: Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction.
Danish: For at holde øje med, om dit barn får en hurtigt indtrædende overfølsomhedsreaktion, kan du og dit barn blive bedt om, at blive et lille stykke tid efter vaccination i konsultationen eller det sted, vaccinationen er foregået.
English: In children who received an acellular pertussis combination vaccine containing Hib in the primary infant immunisation series the Hib booster dose should be given before the age of 2 years.
Danish: Hib boostervaccination skal gives før 2-års alderen til børn, som i det primære børnevaccinationsprogram tidligere har fået en kombineret acellulær pertussis-vaccine indeholdende Hib.
English: In a trial of primary vaccination, concomitant administration of an investigational vaccine containing the same amount of conjugated Hib and MenC saccharides as in Menitorix with DTPa-HBV-IPV* and a licensed pneumococcal saccharide conjugated vaccine (the three injections were made into anatomically distant sites) gave similar immune responses to the seven pneumococcal serotypes as achieved in a group that received DTPa-HBV-IPV* concomitantly with Hib (conjugated to tetanus toxoid) and a licensed pneumococcal saccharide conjugated vaccine.
Danish: I et forsøg med primær vaccination sås sammenlignelige immunrespons ved samtidig administration af en undersøgelsesvaccine, der indeholdt samme mængde konjugeret Hib og MenC saccharid som i Menitorix med DTPa- HBV-IPV*, og en godkendt, konjugeret pneumokoksaccharid-vaccine (de tre injektioner blev givet på anatomisk fjerntliggende steder).
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:
Danish: Procentdelen af børn med en antistoftitre ≥ ”assay cut-off” en måned efter boostervaccination med Menitorix administreret alene eller samtidig med en DTPa-HBV-IPV*-vaccine var følgende:
English: 1 vial: Powder 1 pre-filled syringe: Solvent 2 needles
Danish: 1 hætteglas: Pulver 1 fyldt injektionssprøjte: Solvens 2 kanyler
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menitorix and associated names (see Annex I) solvent for solution for injection [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Menitorix, og associerede navne (se Bilag I) solvens til injektionsvæske, opløsning [Se Bilag IUdfyldes nationalt] i.m.
English: Active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Danish: Aktiv immunisering af spædbørn og børn i alderen fra 2 måneder op til 2 år til forebyggelse af invasive sygdomme forårsaget af Haemophilus influenzae type b (Hib) og Neisseria meningitis serogruppe C (MenC).
English: This leaflet was last approved in {MM/YYYY} [To be completed nationally]
Danish: Denne indlægsseddel blev senest godkendt november 2007 [Udfyldes nationalt]
English: After two doses N=111
Danish: Antistof efter to doser N = 111
English: Primary vaccination in infants from 2 months up to 12 months of age:
Danish: Primærvaccination af børn fra 2 måneder op til 12-måneders alderen: Tre injektioner á 0,5 ml gives med mindst 1 måneds interval.
English: ♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
Danish: ♦ Sjælden (det sker ved mindre end 1 ud af 1000, men ved flere end 1 ud af 10000 vaccinationer)
English: • Generally feeling unwell
Danish: • Følelse af utilpashed
English: Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally]
Danish: Menitorix, og associerede navne (se Bilag I) pulver og solvens til injektionsvæske, opløsning Konjugeret Haemophilus type b- og Meningokok gruppe C-vaccine [Se Bilag I - Udfyldes nationalt]
English: Furthermore the CHMP considers that data on the persistence of SBA titres for up to 5 years after boosting with Menitorix alone cannot predict the longer-term protective effect of vaccination, which can only be estimated by detailed surveillance of disease and therefore agrees with the proposed revised SPC which accurately and comprehensively reflects the extensive body of data that has already been accumulated with respect to the immunity afforded by this vaccine.
Danish: Derudover mener CHMP ikke, at man alene på baggrund af data om persistens af SBA-titre i op til 5 år efter boosting med Menitorix kan forudsige, at vaccinationen har en beskyttende effekt på længere sigt.
English: Compared to the two control groups that received either Menitorix or MMR alone the immune responses to the antigens in both vaccines were not affected by concomitant administration.
Danish: Immunresponset for antigen for begge vacciner ved samtidig administration blev ikke påvirket sammenlignet med de to kontrolgrupper, som modtog enten Menitorix eller MFR alene (se pkt.
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml)
Danish: Anti-PRP-antistoffer mikrogram/ml ≥ 1 mikrogram/ml 100 % GMC (mikrogram/ml)
English: N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Danish: N = antal børn med tilgængelige resultater % = procentdel af børn med en titer lig med eller over “the cut-off” PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer † = børn ≤ 18 uger ved tredje dosis af Menitorix
English: Clinical trials have evaluated the antibody responses at one month after two doses and after completion of a 3-dose primary vaccination course of Menitorix (co-administered with DTPa-HBVIPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
Danish: Antistofresponset er i kliniske forsøg vurderet en måned efter to doser og igen efter afslutningen af det primære 3-dosis-vaccinationsprogram med Menitorix (administreret sammen med DTPa-HBV-IPV eller DTPa-IPV vacciner).
English: The size of the safety database derived from clinical studies and the similarity of this new vaccine to already licensed products were both reasons to accept the database provided, which is supported by the fact that that the available safety data do not indicate any unusual problems.
Danish: Grunden til, at den udleverede database blev accepteret, var dels størrelsen af sikkerhedsdatabasen fra de kliniske undersøgelser, dels lighederne imellem denne nye vaccine og allerede godkendte produkter.
English: Menitorix
Danish: Trometamol
English: After primary vaccination in infancy, booster doses of Hib and MenC must be administered.
Danish: Det er nødvendigt, at give børn en boostervaccination af Hib og MenC efter den primære vaccination.
English: Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I - To be completed nationally]
Danish: Menitorix, pulver og solvens til injektionsvæske, opløsning [Se Bilag I - Udfyldes nationalt]
English: If Menitorix is used to boost protection against Hib and MenC:
Danish: Hvis Menitorix gives som boostervaccination mod Hib eller MenC.
English: After the first course of vaccinations against Hib and MenC has been completed a booster dose of Hib and MenC should be given, usually at some time in the second year of life.
Danish: Når hele vaccinationsprogrammet mod Hib og MenC er afsluttet, skal der gives en boostervaccination.
English: NAME OF THE MEDICINAL PRODUCT Menitorix and associated names (see Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Menitorix, og associerede navne (se Bilag I) pulver til injektionsvæske, opløsning Konjugeret Haemophilus type b- og Meningokok gruppe C-vaccine [Se Bilag I - Udfyldes nationalt] i.m.