FrancophonIA/ELRC3.0 huggingface dataset:
English: In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.
Danish: Hos unge var sikkerhed og tolerance af vaccinen favorabel i relation til Tdap og blev ikke ændret markant ved samtidig eller sekventiel administration af andre vacciner.
English: The presence of a minor infection is not a contraindication.
Danish: Tilstedeværelse af lette grader af infektion er dog ikke en kontraindikation.
English: GMTs declined over time as expected but remained between 2- and 8-fold higher than prebooster values (Table 8).
Danish: GMT'erne faldt over tid som forventet, men forblev mellem 2 og 8 gange højere end værdierne forud for boosterdosen (Tabel 8).
English: Separate injection sites must be used if more than one vaccine is being administered at the same time.
Danish: Der skal anvendes forskellige indsprøjtningssteder, hvis der gives mere end én vaccine på samme tid.
English: Menveo is a powder and a solution for injection.
Danish: Menveo er et pulver og en opløsning til injektion.
English: A randomised, observer-blind study was conducted in children 12 to 59 months of age in Finland and Poland (V59P7).
Danish: Et randomiseret, observatørblindet studie blev gennemført hos børn i alderen 12-59 måneder i Finland og Polen (V59P7).
English: The clinical benefit of a 2-dose vaccination series in children 2 through 10 years of age is not known.
Danish: Den kliniske fordel ved en vaccinationsserie med 2 doser hos børn i alderen 2-10 år kendes ikke.
English: - ever had an allergic reaction to the active substances or any of the other ingredients of this vaccine (listed in section 6) - ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines) - an illness with high fever.
Danish: - nogensinde har haft en allergisk reaktion over for det aktive stof eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6) - nogensinde har haft en allergisk reaktion over for difteritoksoid (et stof, der anvendes i en række andre vacciner) - har en sygdom med høj feber.
English: Five doses (10 vials) per package.
Danish: Fem doser (10 hætteglas) pr. pakning.
English: The vaccine is usually given into the upper arm muscle (deltoid) for children (from 2 years of age), adolescents and adults.
Danish: Vaccinen gives normalt i overarmsmusklen (deltoideus) hos børn (fra 2 år), unge og voksne.
English: 6-10 years
Danish: 6-10 år
English: A significant increase in the hSBA GMTs against all four serogroups was also observed at 7 and 28 days after the booster dose (Table 8).
Danish: En signifikant stigning i hSBA-GMT'erne mod alle fire serogrupper blev også observeret 7 og 28 dage efter boosterdosen (tabel 8).
English: This may temporarily affect the ability to drive or use machines.
Danish: Dette kan midlertidigt påvirke evnen til at køre eller benytte maskiner.
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Danish: I tilfælde af fremmedpartikler og/eller synlige forandringer kasseres vaccinen.
English: The powder is a white to off- white cake.
Danish: Hvidt til off-white pulver (kage).
English: Date of latest renewal: 04 December 2014
Danish: Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 4. december 2014
English: 5 micrograms
Danish: 5 mikrogram
English: The solution is a colourless clear solution.
Danish: Opløsningen er en farveløs, klar opløsning.
English: 21 months 3 years 5 years
Danish: 21 måneder 3 år
English: If you or your child received a dose of Menveo more than one year ago and remains at particular risk of exposure to meningococcal group A bacteria, consideration may be given to administering a booster dose to maintain protection.
Danish: Hvis du eller dit barn har fået en dosis Menveo for mere end et år siden og stadig er i særlig risiko for at blive udsat for meningokokgruppe A-bakterien, kan det overvejes at give en boosterdosis for at vedligeholde beskyttelsen.
English: 6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
Danish: 6.6 Regler for bortskaffelse og anden håndtering Menveo skal klargøres til administration ved at rekonstituere pulveret (i hætteglas) med opløsningen (i hætteglas).
English: Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product.
Danish: Vend hætteglasset på hovedet, ryst det kraftigt, og træk derefter 0,5 ml rekonstitueret produkt op.
English: One dose (2 vials) per package.
Danish: Én dosis (2 hætteglas) pr. pakning.
English: There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Danish: Der foreligger ingen data for anvendelse af vaccinen som profylakse efter eksponering.
English: Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.
Danish: Antistofrespons på Menveo og difteri, tetanus eller HPV-vaccinekomponenter blev ikke påvirket negativt af samtidig administration.
English: If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.
Danish: Hvis den vaccinerede person får immunsupprimerende behandling, er der risiko for nedsat immunologisk respons.
English: Menveo does not protect against diphtheria.
Danish: Menveo beskytter ikke mod difteri.
English: There was evidence of some suppression of antibody response to two of the three pertussis antigens.
Danish: Der blev påvist nogen suppression af antistofrespons på to af de tre pertussis-antigener.
English: Each dose of Menveo is supplied as a: - 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder - 1 Vial containing the MenCWY Liquid Conjugate Component as clear solution - Pack size of one dose (2 vials) or five doses (10 vials).
Danish: Hver dosis af Menveo leveres som: - 1 hætteglas indeholdende MenA frysetørret konjugat komponent som et hvidt til off-white pulver - 1 hætteglas indeholdende MenCWY flydende konjugeret komponent som en klar opløsning - Pakningsstørrelser på én dosis (2 hætteglas) eller 5 doser (10 hætteglas).
English: Not for intravascular, subcutaneous or intradermal injection.
Danish: Ikke til intravaskulær, subkutan eller intradermal injektion.
English: Pack size of one dose (2 vials) or five doses (10 vials).
Danish: Pakningsstørrelser på 1 dosis (2 hætteglas) eller 5 doser (10 hætteglas).
English: V59P6E1 (5 years post vaccination)
Danish: V59P6E1 (5 år efter vaccination)
English: One dose (0.5 ml of the reconstituted vaccine) contains: The active substances are: (Originally contained in the powder)
Danish: En dosis (0,5 ml rekonstitueret vaccine) indeholder: Aktive stoffer: (Oprindeligt indhold i pulver)
English: The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.
Danish: Karakteriseringen af Menveos sikkerhedsprofil hos børn i alderen 2-10 år er baseret på data fra fire kliniske studier, hvor 3.181 personer fik Menveo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis (0,5 ml rekonstitueret vaccine) indeholder: (Oprindeligt indeholdt i pulver)
English: Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08.
Danish: Farmakoterapeutisk klassifikation: Meningokokvacciner, ATC-kode: J07AH08.
English: Insufficient clinical data on exposed pregnancies are available.
Danish: Der foreligger utilstrækkelige kliniske data for anvendelse under graviditet.
English: The safety and efficacy of Menveo in children under 2 years of age has not yet been established.
Danish: Menveos sikkerhed og virkning hos børn under 2 år er endnu ikke klarlagt.
English: Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine.
Danish: Menveo kan gives som boosterdosis hos personer, som tidligere har fået primær vaccination med Menveo, anden konjugeret meningokokvaccine eller ukonjugeret meningokokvaccine polysaccharid.
English: Not known: hypersensitivity including anaphylaxis
Danish: Ikke kendt: overfølsomhed inklusive anafylaksi
English: After reconstitution 0.5 ml dose contains:
Danish: Efter rekonstitution indeholder 1 dosis på 0,5 ml:
English: MARKETING AUTHORISATION NUMBERS EU/1/10/614/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/614/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/614/003 - 1 dose pack EU/1/10/614/002 - 5 doses pack
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/614/003 - Pakning med 1 dosis EU/1/10/614/002 - Pakning med 5 doser
English: Common: eating disorder
Danish: Almindelige: spiseforstyrrelser
English: MenCWY Conjugate
Danish: MenCWY konjugat
English: It should be checked if the adverse reactions may be intensified by any co-administration.
Danish: Det bør undersøges, om bivirkningerne kan blive forstærket som følge af samtidig administration.
English: If an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.
Danish: Hvis en person menes at have en særlig risiko for eksponering for Men A, og vedkommende har fået en dosis Menveo for mere end et års tid siden, kan det overvejes at give en booster-dosis.
English: There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.
Danish: Der foreligger kun begrænsede data for personer i alderen 56-65 og ingen data for personer > 65 år.
English: Keep the vials in the outer carton in order to protect from light.
Danish: Opbevar hætteglassene i den ydre emballage for at beskytte mod lys.
English: For instructions on preparation and reconstitution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age.
Danish: Der foreligger ikke tilstrækkelige data til at klarlægge Menveos virkning hos børn under 2 år.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, og er reelt ”natriumfrit”.
English: Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined.
Danish: I betragtning af alvorligheden af invasiv meningokoksygdom forårsaget af Neisseria meningitidis-serogruppe A, C, W-135 og Y bør graviditet ikke udelukke vaccination ved en klart defineret risiko for eksponering.
English: Menveo should under no circumstances be administered intravascularly.
Danish: Menveo må under ingen omstændigheder gives intravaskulært.
English: Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; fits (convulsions) including fits associated with fever; balance disorder; faint; infection of the skin at the injection site; injection site swelling, including extensive swelling of the injected limb.
Danish: Allergiske reaktioner, som kan omfatte svær hævelse af læber, mund, hals (kan medføre synkebesvær), åndedrætsbesvær med hvæsen eller hoste, udslæt og hævede hænder, fødder og ankler, bevidstløshed, meget lavt blodtryk; krampeanfald, herunder feberkramper; balanceforstyrrelser; besvimelse; infektion i huden på injektionsstedet; hævelse på injektionsstedet, herunder kraftig hævelse af den injicerede arm/ben.
English: A small decline was observed in percentages of subjects with hSBA ≥ 1:8 against serogroup A, although percentages were still high (77% to 79%).
Danish: En lille reduktion i procentdelen af personer med hSBA ≥ 1:8 blev observeret for serogruppe A, men procentdelen var stadig høj (77 % til 79 %).
English: Prior to injection, change the needle for one suitable for the administration.
Danish: Før injektion skiftes til en kanyle, der er egnet til administration.
English: Common: nausea, vomiting, diarrhea
Danish: Almindelige: kvalme, opkastning, diarré
English: Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Danish: Fortæl det til lægen, hvis du tidligere har fået en injektion med Menveo eller en anden meningokokvaccine.
English: The characterization of the safety profile of Menveo in adolescents and adults is based on data from five randomised controlled clinical trials including 6401 participants (from 11-65 years of age) who received Menveo.
Danish: Karakteriseringen af Menveos sikkerhedsprofil hos unge og voksne er baseret på data fra fem randomiserede, kontrollerede kliniske studier, der inkluderede 6.401 deltagere (fra 11-65 år), der modtog Menveo.
English: The list provided below presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class.
Danish: Nedenfor vises de bivirkninger, der er blevet rapporteret i tre pivotale og to understøttende kliniske studier, listet efter systemorganklasse.
English: 7.1 to 12.5 micrograms
Danish: 7,1 til 12,5 mikrogram
English: Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Danish: Besvimelse og følelse af svaghed eller andre stressrelaterede reaktioner kan opstå i forbindelse med enhver injektion med kanyle.
English: Immunogenicity was evaluated in randomised, multicenter, active controlled clinical trials that enrolled children (2-10 years of age), adolescents (11-18 years of age), adults (19-55 years of age) and older adults (56-65 years of age).
Danish: Immunogenicitet blev evalueret i randomiserede og aktivt kontrollerede kliniske multicenterstudie, hvori børn (2-10 år), unge (11-18 år), voksne (19-55 år) og ældre voksne (56-65 år) deltog.
English: The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination.
Danish: Børnene fik også en Menveo-boosterdosis 5 år efter primær vaccination med en enkelt dosis.
English: Menveo's effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.
Danish: Virkningen af Menveo kan blive nedsat, hvis du vaccineres, mens du tager medicin, der undertrykker immunsystemet.
English: Little is known about the effectiveness of Menveo when administered to individuals with weakened immunity due to the use of immunosuppressive medications, or HIV infection, and other possible causes.
Danish: Der er begrænset kendskab til effektiviteten af Menveo hos personer, hvor immunsystemet fungerer dårligere på grund af immunhæmmende medicin, hiv-infektion eller andre årsager.
English: In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response.
Danish: Blandt immunkompromitterede personer kan vaccination muligvis ikke medføre en tilstrækkelig beskyttende antistofrespons.
English: Menveo ACWYPS Menveo ACWY-P S Menveo ACWYPS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
Danish: Menveo ACWY -PS Menveo ACWY-PS Menveo ACWY-P S Menveo ACWY-P S A N = 280 N = 281 N = 280 N = 281 N = 253 N = 238 N = 253 N = 238
English: 2-5 years
Danish: 2-5 år
English: Immunogenicity in children 2 to 10 years of age
Danish: Immunogenicitet hos børn i alderen 2 til 10 år
English: As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
Danish: Som det gælder for alle vacciner, er det ikke sikkert, at Menveo giver fuld beskyttelse til alle, som får vaccinen.
English: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
Danish: GSK Vaccines S.r.l., Bellaria-Rosia, 53018, Sovicille (Siena), Italien
English: It must not be administered intravascularly, subcutaneously or intradermally.
Danish: Må ikke administreres intravaskulært, subkutant eller intradermalt.
English: General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke kendt: cellulitis på injektionsstedet, hævelse på injektionsstedet, herunder kraftig hævelse af den injicerede ekstremitet
English: Long-term antibody persistence data following vaccination with Menveo are available up to 5 years after vaccination (see section 4.4 and 5.1).
Danish: Langtidsdata for antistofpersistens efter vaccination med Menveo er tilgængelige op til 5 år efter vaccination (se pkt.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: I lighed med andre vacciner kan et beskyttende immunrespons ikke med sikkerhed fremkaldes hos alle vaccinerede (se pkt.
English: Neisseria meningitidis serogroup A, C, W-135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Danish: Neisseria meningitidis-gruppe A, C, W-135 og Y-bakterier kan medføre alvorlige og til tider livstruende infektioner som meningitis (hjernehindebetændelse) og sepsis (blodforgiftning).
English: Post-marketing experience (all age groups)
Danish: Bivirkninger indberettet efter markedsføringen (alle aldersgrupper) Immunsystemet:
English: Dizziness has been very rarely reported following vaccination.
Danish: Svimmelhed efter vaccination er rapporteret i sjældne tilfælde.
English: Other medicines and Menveo
Danish: Brug af anden medicin sammen med Menveo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - PULVER I HÆTTEGLAS OG OPLØSNING I HÆTTEGLAS
English: Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.
Danish: Menveo yder ingen beskyttelse mod N. Meningitidis-serogrupper, som ikke er til stede i denne vaccine.
English: 5 year persistence 1 month after booster hSBA
Danish: 1 måned efter booster hSBA
English: This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ‘potassium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol kalium (39 mg) pr. dosis, og er reelt ”kaliumfrit”.
English: Immunogenicity in individuals 11 years of age and above
Danish: Immunogenicitet hos personer i alderen 11 år og derover
English: Available data in children 2 to 23 months of age
Danish: Foreliggende data hos børn i alderen fra 2 til 23 måneder.
English: In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate and water for injection (See also end of Section 2).
Danish: I opløsningen: natriumchlorid, natriumdihydrogenphosphatmonohydrat, dinatriumphosphatdihydrat og vand til injektionsvæsker (se også sidst i punkt 2).
English: Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively.
Danish: Blandt Menveo-vaccinerede var henholdsvis 58,9 %, 16,4 %, 21,3 % og 3,4 % i aldersgrupperne 11-18 år, 19-34 år, 35-55 år og 56-65 år.
English: Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma.
Danish: Menveo er ikke blevet evalueret hos personer med trombocytopeni, blødningslidelser eller i antikoagulerende behandling på grund af risiko for hæmatom.
English: 3.3 to 8.3 micrograms
Danish: 3,3 til 8,3 mikrogram
English: Common: arthralgia
Danish: Almindelige: artralgi
English: The other ingredients (excipients) are:
Danish: Øvrige indholdsstoffer (hjælpestoffer):
English: The differences between hSBA GMTs in the 2-dose and the single dose groups at 1 year after vaccination were lower than those seen at 1 month post-vaccination.
Danish: Forskellene mellem hSBA-GMT'ere i grupperne med 2 doser og med en enkelt dosis 1 år efter vaccination var mindre end forskellene 1 måned post-vaccination.
English: In the pivotal study V59P20 immunogenicity of Menveo was compared to ACWY-D; 1170 children were vaccinated with Menveo and 1161 received the comparator vaccine in the per protocol populations.
Danish: I det pivotale studie V59P20 blev Menveos immunogenicitet sammenlignet med ACWY-D. 1.170 børn blev vaccineret med Menveo, og 1.161 i per protokol-populationerne fik komparator-vaccinen.
English: Powder in vial (type I glass) with a stopper (butyl rubber with fluoropolymer coated surface) and solution in vial (type I glass) with a stopper (butyl rubber).
Danish: Pulver i hætteglas (type I-glas) med prop (butylgummi med en fluoropolymerbelagt overflade) og opløsning i hætteglas (type I-glas) med prop (butylgummi).
English: 16.7 to 33.3 micrograms
Danish: 16,7 til 33,3 mikrogram
English: MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GSK Vaccines S.r.l.
English: A booster dose of Menveo was administered 3 years after primary vaccination with Menveo or ACWY-D.
Danish: En Menveo-boosterdosis blev administreret 3 år efter primær vaccination med Menveo eller ACWY-D.
English: Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Children 2 to 10 years of age
Danish: Børn i alderen 2-10 år
English: What you need to know before you or your child are given Menveo
Danish: Det skal du vide, før du eller dit barn får Menveo
English: Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero).
Danish: Menveo kan gives samtidigt med en hvilken som helst af følgende vacciner: monovalent og kombineret hepatitis A og B, gul feber, tyfus (Vi polysaccharid), japansk encefalitis, rabies og meningokokgruppe B (Bexsero).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om Brailleskrift
English: Anxiety‐related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8 Undesirable effects).
Danish: Angstrelaterede reaktioner, herunder vasovagale reaktioner (synkope), hyperventilering eller stressrelaterede reaktioner kan forekomme i forbindelse med vaccination som et psykogent respons på injektion med kanyle (se pkt.
English: V59P13E1 (3 years post vaccination)
Danish: V59P13E1 (3 år efter vaccinatio n)
English: Serogroup
Danish: Serogruppe
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere information om denne medicin på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years.
Danish: I det pivotale immunogenicitetsstudie, V59P13, blev immunrespons på Menveo blandt voksne i alderen 19 til 55 år evalueret.