FrancophonIA/ELRC3.0 huggingface dataset:
English: Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/newborn child.
Danish: Data fra et meget begrænset antal gravide vaccinerede kvinder viser ikke nogen bivirkninger af Twinrix Voksen ved graviditet eller på helbredstilstanden for foster/nyfødt barn.
English: Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use - the appearance should not be clear.
Danish: Inspicer vaccinen igen: a. Hvis vaccinen fremstår som en ensartet, uklar hvid suspension, er den klar til brugudseendet af vaccinen må ikke være klar.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 dosis (1 ml) indeholder:
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: Som for alle vacciner opnås et beskyttende immunrespons ikke nødvendigvis hos alle vaccinerede.
English: Twinrix Adult is for intramuscular injection, preferably in the deltoid region.
Danish: Twinrix Voksen er til intramuskulær injektion, fortrinsvis i deltoidea-regionen.
English: For some categories of subjects or patients exposed to HBV (e.g; haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Danish: For nogle kategorier af personer eller patienter, som har øget risiko for HBV (f.eks hæmodialyse- eller immunkompromitterede patienter) skal sikkerhedsforanstaltninger overvejes for at sikre et beskyttende antistofniveau ≥ 10 IE/l.
English: The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Danish: Nedennævnte sikkerhedsprofil er fremkommet ved sammenlagt analyse af hændelser per dosis fra flere end 6.000 personer, som modtog enten standardvaccinationsprogrammet 0, 1, 6 måneder (n = 5.683) eller det accelererede vaccinationsprogram 0, 7, 21 dage (n = 320).
English: Thrombocytopenia, thrombocytopenic purpura
Danish: Trombocytopeni, trombocytopenisk purpura
English: In the event of either being observed, do not administer the vaccine.
Danish: Hvis noget af dette observeres må vaccinen ikke administreres.
English: Twinrix Adult can also be given as a total of three doses over 1 month.
Danish: Twinrix Voksen kan også gives som tre injektioner i løbet af 1 måned.
English: Date of latest renewal: 28 August 2006
Danish: Dato for første markedsføringstilladelse: 20. september 1996 Dato for seneste fornyelse: 28. august 2006
English: Obesity (defined as BMI ≥ 30 kg/m2) has been observed to reduce the immune response to hepatitis A vaccines.
Danish: Overvægt (defineret som BMI ≥ 30 kg/m2) kan reducere immunrespons over for hepatitis A-vacciner.
English: Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis
Danish: Multipel sklerose, myelitis, facialisparese, polyneuritis såsom Guillain-Barré syndrom (med ascenderende paralyse), opticusneuritis
English: If you miss a scheduled injection, talk to your doctor and arrange another visit.
Danish: Hvis du ikke får en planlagt injektion, skal du tale med din læge og få en ny tid.
English: Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Danish: Ved opbevaring kan et fint hvidt bundfald med et klart farveløst lag ovenpå observeres.
English: The seroprotection rate against hepatitis B increased to 95.1% by three months after the first dose.
Danish: Det beskyttende niveau mod hepatitis B steg til 95,1 % tre måneder efter første dosis.
English: • Diarrhoea, nausea
Danish: • Diarré, kvalme
English: A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Danish: En række faktorer kan reducere immunrespons over for hepatitis B-vacciner.
English: 0.4 milligrams Al3+
Danish: 0,4 milligram Al3+
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 25 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 25 PRE-FILLED SYRINGES WITH 25 NEEDLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 25 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 1 FYLDT INJEKTIONSSPRØJTE MED 1 KANYLE 10 FYLDTE INJEKTIONSSPRØJTER MED 10 KANYLER 25 FYLDTE INJEKTIONSSPRØJTER MED 25 KANYLER
English: Frequencies are reported as: Very common: ≥ 1/10 Common:
Danish: Hyppighederne er rapporteret som: Meget almindelig:
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Danish: Det er endnu ikke fuldstændigt fastlagt, hvorvidt immunkompetente personer, som har responderet på hepatitis A-vaccination, vil behøve en boosterdosis, eftersom der ved fravær af påviselige antistoffer muligvis kan opnås beskyttelse ved hjælp af immunologisk memory.
English: • Inflammation of some blood vessels (vasculitis)
Danish: • Betændelse i visse blodkar (vasculitis)
English: Twinrix Adult should under no circumstances be administered intravascularly.
Danish: Twinrix Voksen må under ingen omstændigheder administreres intravaskulært.
English: 6.6 Special precautions for disposal and other handling Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ved opbevaring kan et fint hvidt bundfald med et klart farveløst lag ovenpå observeres.
English: • Abnormal laboratory liver test results
Danish: • Unormale resultater af leverprøver
English: Twinrix Adult confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti-HBs antibodies.
Danish: Twinrix Voksen giver immunitet mod HAV- og HBV-infektion ved at inducere specifikke anti-HAVog anti-HBs-antistoffer.
English: Concentrations (GMC) increased by 179-fold (GMC of 7234 mIU/ml) indicative of an immune memory response.
Danish: mIE/ml) og den geometriske middelkoncentration (GMC) var forøget med en faktor 179 (GMC på 7.234 mIE/ml) som tegn på immunologisk hukommelse.
English: Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response.
Danish: Din læge vil muligvis tage en blodprøve efter sidste vaccination for at kontrollere, om du har opnået et tilstrækkeligt beskyttelsesniveau.
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) kan opstå efter og endda før vaccination især hos unge mennesker, som en psykogen reaktion over for kanylestik.
English: The remaining 2 doses will be given 7 days and 21 days after the first dose.
Danish: De to næste doser gives henholdsvis 7 dage og 21 dage efter den første dosis.
English: HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells.
Danish: HBsAg er produceret ved kultur af gensplejsede gærceller i et selektivt medium
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
Danish: Hos hæmodialysepatienter og personer med svækket immunsystem opnås ikke altid adækvat anti-HAV- og anti-HBs-antistoftiter efter det primære immuniseringsprogram, hvorfor sådanne patienter kan have behov for yderligere doser af vaccinen.
English: Re-suspension of the vaccine to obtain a uniform hazy white suspension
Danish: Resuspension af vaccinen for at opnå en ensartet, uklar hvid suspension
English: • Swelling of the face, mouth or throat (angioneurotic oedema)
Danish: • Hævelse af ansigt, mund eller hals (angioneurotisk ødem)
English: Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Danish: Twinrix Voksen er indiceret til brug hos ikke-immuniserede voksne og unge på 16 år og derover, som er i risiko for at pådrage sig både hepatitis A- og hepatitis B-infektion.
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Danish: I tilfælde, hvor de monovalente hepatitis A- og hepatitis B-vacciner blev administreret sammen med specifikke immunglobuliner, sås ingen påvirkning af serokonverteringen, skønt det kan resultere i lavere antistoftiter.
English: Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Danish: De sero-positive rater for anti-HAV-antistoffer var 100 %, 99,5 % og 100 % første, anden og tredje måned efter den initiale dosis.
English: Talk to your doctor or pharmacist before receiving Twinrix Adult if
Danish: Kontakt lægen eller apotekspersonalet, før du får Twinrix Voksen, hvis:
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Danish: Det forventes ikke, at rekombinant hepatitis B-virus overflade-antigen medfører bivirkinger ved graviditet eller på forsteret men, det anbefales at udskyde vaccination til efter fødsel med mindre, det skønnes tvingende nødvendigt at beskytte moderen mod en hepatitis B-infektion.
English: Twinrix Adult contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Danish: Twinrix Voksen indeholder neomycin Fortæl lægen, hvis du er overfølsom over for neomycin (et antibiotikum).
English: In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below.
Danish: I de to kliniske studier, hvor Twinrix Voksen blev administreret ved dag 0, 7 og 21, blev generaliserede og lokale symptomer set med samme frekvens som nævnt nedenfor.
English: • Inflammation of nerves (neuritis)
Danish: • Nervebetændelse (neuritis)
English: PHARMACEUTICAL FORM Suspension for injection.
Danish: LÆGEMIDDELFORM Injektion, suspension.
English: This disease is caused by the hepatitis A virus.
Danish: Denne sygdom er forårsaget af hepatitis A-virus.
English: • you have a bleeding problem or bruise easily.
Danish: • du har tendens til blødninger eller let får blå mærker.
English: Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines.
Danish: Alternativt kan personer, som er påbegyndt Twinrix Voksen, gives en boosterdosis af en af de monovalente vacciner.
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Danish: Anti-HBs- og Anti-HAV-antistoftitrene, som påvises efter et primært vaccinationsforløb med den kombinerede vaccine, ligger inden for samme område som de, der ses efter vaccination med de monovalente vacciner.
English: Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Danish: Encefalitis, encefalopati, neuritis, neuropati, paralyse, kramper
English: In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i.e. at months 1 and 2 after the initial dose).
Danish: I kliniske studier hvor Twinrix Voksen blev administreret efter dette program, havde 82 % og 85 % af de vaccinerede beskyttende niveauer af anti-HBV-antistoffer efter henholdsvis 1 og 5 uger efter den tredje dosis (dvs. ved 1. og 2. måned efter den initiale dosis).
English: It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Danish: Nogle personer kan være i inkubationsfasen af en hepatitis A- eller hepatitis B-infektion på vaccinationstidspunktet.
English: Hepatitis A virus (inactivated)1,2
Danish: Hepatitis A-virus (inaktiveret)1.2
English: • Loss of skin sensitivity to pain or touch (hypoaesthesia)
Danish: • Nedsat følsomhed i huden over for smerter og berøring (hypoæstesi)
English: When re-suspended, the vaccine will have a uniform hazy white appearance.
Danish: Efter resuspension, vil vaccinen have et ensartet, uklart hvidt udseende.
English: The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Danish: Følgende bivirkninger er set ved enten Twinrix eller ved GlaxoSmithKlines monovalente hepatitis A- og B-vacciner:
English: Specific humoral antibodies against hepatitis B were observed in 70% of the adults after the first dose and approximately 99% after the third dose.
Danish: Specifikke humorale antistoffer mod hepatitis B påvistes hos 70 % af de voksne efter første dosis og hos omkring 99 % efter den tredie dosis.
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Danish: Hos patienter, som får immunsuppresiv behandling eller har nedsat immunforsvar, kan adækvat respons ikke altid forventes opnået.
English: Uncommon Vomiting, abdominal pain*
Danish: Opkastning, abdominalsmerter*
English: The excretion of Twinrix Adult in milk has not been studied in animals.
Danish: Udskillelsen af Twinrix Voksen i mælk er ikke undersøgt hos dyr.
English: • you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
Danish: • du tidligere har haft en overfølsomhedsreaktion over for andre vacciner mod hepatitis A eller hepatitis B.
English: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Danish: Anafylaksi, allergiske reaktioner inklusive anafylaktoide reaktioner og serumsyge-lignende sygdom
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Danish: Når det primære vaccinationsprogram er påbegyndt, skal det afsluttes med den samme vaccine.
English: The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively.
Danish: De hyppigst rapporterede bivirkninger efter Twinrix Voksen, administreret efter 0, 1, 6 måneders standardprogrammet, er smerter og rødme med en frekvens pr. dosis på henholdsvis 37,6 % og 17,0 %.
English: The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Danish: De kinetiske forhold vedrørende nedgangen i indholdet af anti-HAV og anti-HB påvistes at være lig med de monovalente vacciners.
English: The remaining two doses will be given one month, and six months after the first dose.
Danish: De næste to doser gives henholdsvis en måned og seks måneder efter den første dosis.
English: Twinrix Adult is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Danish: Twinrix Voksen anbefales ikke til post-ekspositionsprofylakse (f.eks. stikuheld med kanyle).
English: In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94% of the adults one month after the first dose and in 100% one month after the third dose (i.e. month 7).
Danish: I kliniske studier påvistes specifikke humorale antistoffer mod hepatitis A hos ca. 94 % af de voksne personer en måned efter den første vaccination, og hos 100 % en måned efter den tredie dosis (dvs måned 7).
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives
Danish: • Rød-violette blærer eller knuder på huden (lichen planus), alvorligt udslæt (erythema multiforme), nældefeber
English: The vaccine should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less.
Danish: Vaccinen må ikke gives dybt i huden eller i sædemusklen, da virkningen herved kan forringes.
English: The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Danish: Virkningen af Twinrix Voksen på fostrets, den perinatale og postnatale overlevelse og udvikling er undersøgt på rotter.
English: The vaccine should be re-suspended following the steps below.
Danish: Vaccinen skal resuspenderes i henhold til nedenstående vejledning.
English: A poor response to the vaccine, possibly without achieving protection against hepatitis A, has been observed in obese people.
Danish: En utilstrækkelig virkning af vaccinen, som kan medføre, at der ikke opnås beskyttelse mod hepatitis A, er set hos overvægtige personer.
English: A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Twinrix Adult should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult therapy to the woman.
Danish: Beslutningen om hvorvidt amningen skal forsættes eller stoppes, eller hvorvidt behandlingen med Twinrix Voksen skal forsættes eller stoppes, må afhænge af en vurdering af fordelene for hhv. amningen af barnet og behandlingen af moderen.
English: 1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Danish: 1 ml suspension i en fyldt injektionssprøjte (type I glas) med stempelprop (butylgummi).
English: Very common Headache Uncommon Dizziness Rare
Danish: Udslæt, pruritus Meget sjælden Urticaria
English: Twinrix Adult is available in packs of 1, 10, and 25 with or without needles.
Danish: Twinrix Voksen findes i pakninger med 1, 10 og 25 fyldte injektionssprøjter med og uden nåle.
English: • Pain and redness at the injection site
Danish: • Smerte og rødme ved injektionsstedet
English: Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
Danish: Overfølsomhed ved tidligere indgift af hepatitis A- og/eller hepatitis B-vacciner.
English: When this schedule is applied, a fourth dose is recommended 12 months after the first dose.
Danish: I disse specielle situationer anbefales en fjerde dosis 12 måneder efter den første dosis.
English: If not, your doctor will advise you on the possible need to have extra doses.
Danish: Hvis du ikke har det, vil din læge muligvis give dig ekstra vaccinationer.
English: A fourth dose is recommended at 12 months.
Danish: Det anbefales, at der gives yderligere en fjerde dosis efter 12 måneder.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISKE AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Danish: I sammenlignende studier var frekvensen af bivirkninger (der aktivt blev spurgt til) efter administration af Twinrix Voksen, den samme som frekvensen af bivirkninger (der aktivt blev spurgt til) efter administration af de monovalente vacciner.
English: Anti-HBs antibody concentrations decreased as age and body mass index increased; they were also lower in male than in female subjects.
Danish: Anti-HB-antistofkoncentrationen faldt med stigende alder og body mass index.
English: • Immediate injection site pain, stinging and burning feeling
Danish: • Smerte ved injektionsstedet umiddelbart efter injektion, sviende og brændende fornemmelse.
English: It is unknown whether Twinrix Adult is excreted in human breast milk.
Danish: Det er ukendt, om Twinrix Voksen udskilles i human mælk.
English: The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Danish: Virkningen af Twinrix Voksen på fostrets, den perinatale og postnatale overlevelse og udvikling er ikke undersøgt prospektivt i kliniske studier.
English: For the full list of excipients, see section 6.1.
Danish: Alle hjælpestoffer er anført under pkt.6.1
English: • Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Danish: • Influenzalignende symptomer som høj feber, ondt i halsen, løbende næse, hoste og kulderystelser.
English: - Booster dose
Danish: - Boosterdosis
English: • Fever equal to or greater than 37.5°C
Danish: • Feber på 37,5 °C eller derover.
English: As indicated in section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Danish: Som beskrevet i afsnit 2, kan en utilstrækkelig virkning af vaccinen medføre, at du ikke opnår beskyttelse mod hepatitis B. Dette sker oftere for ældre personer, for mænd frem for kvinder, for rygere og for overvægtige personer samt for personer med langvarig sygdom eller personer, der tager visse typer medicin.
English: However, exceptionally Twinrix Adult can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Danish: Hos personer med trombocytopeni eller blødningsforstyrrelser kan Twinrix Voksen dog administreres subkutant, da blødning kan forekomme efter en intramuskulær adminstration hos sådanne personer (se pkt.
English: Angioneurotic oedema, lichen planus, erythema multiforme
Danish: Angioødem, lichen ruber, erythema multiforme
English: Twinrix Adult is a white, slightly milky liquid presented in a glass pre-filled syringe (1 ml).
Danish: Twinrix Voksen en en hvid, næsten mælkeagtig væske i en fyldt injektionssprøjte (1 ml).
English: 1 dose (1 ml)
Danish: 1 dosis (1 ml)
English: A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Danish: En utilstrækkelig virkning af vaccinen, som kan medføre, at der ikke opnås beskyttelse mod hepatitis B, er også set hos ældre personer, hos flere mænd end kvinder, hos rygere og hos overvægtige personer samt hos personer med langvarig sygdom eller personer, der tager visse typer medicin.
English: What you need to know before you receive Twinrix Adult
Danish: Det skal du vide, før du får Twinrix Voksen
English: • Swelling or infection of the brain (encephalitis)
Danish: • Hævelse i hjernen eller hjernebetændelse (encephalitis)
English: The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% at both 7 and 48 months versus 99% and 93% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% and 97% after another licensed monovalent hepatitis A vaccine.
Danish: Det seropositive niveau for anti-HAV-antistoffer efter Twinrix Voksen var 97 % både efter 7 og 48 måneder, mens det var 99 % og 93 % med GlaxoSmithKline Biologicals monovalente hepatitis Avaccine og 99 % og 97 % efter en anden registreret monovalent hepatitis A-vaccine.
English: Arthritis, muscular weakness
Danish: Artritis, muskelsvaghed