FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use this vaccine after the expiry date which is stated on the carton.
Danish: • Brug ikke vaccinen efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Fendrix should be injected intramuscularly in the deltoid region.
Danish: Fendrix skal indgives intramuskulært i deltoidea-regionen.
English: • Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Danish: • Fendrix er en hvid, mælkeagtig suspension i en fyldt injektionssprøjte (0,5 ml).
English: Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine.
Danish: Efter påbegyndelse skal det primære vaccinationsprogram fuldføres med Fendrix ved 0, 1, 2 og 6 måneder og ikke med en anden kommercielt tilgængelig HBV-vaccine.
English: • You will have a series of four injections.
Danish: • Du vil få fire injektioner i alt.
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Danish: Disse kan være lokalt eller mere omfattende hududslæt, som kan være kløende eller med blærer, hævelse af øjnene eller ansigtet, åndedræts- eller synkebesvær, pludseligt blodtryksfald og bevidsthedstab.
English: The administration of Fendrix should be postponed in subjects suffering from acute severe febrile illness.
Danish: Administration af Fendrix skal udskydes hos personer, som lider af en akut alvorlig febril lidelse.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C)
English: Contents of the pack and other information What Fendrix contains
Danish: Pakningsstørrelser og yderligere oplysninger Fendrix indeholder:
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: No increase in the reactogenicity was observed after the booster vaccination with respect to the primary vaccination.
Danish: Der sås ingen øget reaktogenicitet efter booster-vaccination i forhold til det primære vaccinationsprogram.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having Fendrix.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med læge eller apoteket, før du får Fendrix.
English: However, in circumstances where exposure to HBV has recently occurred (e.g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites.
Danish: Under omstændigheder, hvor eksponeringen for HBV lige er sket (fx ved nålestik med kontamineret nål), og hvor samtidig administration af Fendrix og en standarddosis HBIg er påkrævet, skal der anvendes i forskellige injektionssteder.
English: It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Danish: Det må forventes, at også hepatitis D kan forbygges ved immunisering med Fendrix, eftersom hepatitis D (forårsaget af delta virus) ikke forekommer, når der ikke er infektion med hepatitis B.
English: If not, you may not be fully protected against the disease.
Danish: Elles kan du ikke være sikker på fuldstændig beskyttelse mod sygdommen.
English: What you need to know before you receive Fendrix
Danish: Det skal du vide, før du får Fendrix
English: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines.
Danish: Anafylaktiske reaktioner, allergiske reaktioner inklusive anafylaktoide reaktioner og serumlignende sygdom er meget sjældent blevet rapporteret for hepatitis B-vacciner.
English: • The active substance in 1 dose (0.5 ml) of Fendrix is: Hepatitis B surface antigen 1, 2, 3
Danish: • Aktivt stof i 1 dosis (0,5 ml) Fendrix: Hepatitis B-overfladeantigen1,2,3
English: Fendrix is a vaccine which prevents hepatitis B.
Danish: Fendrix er en vaccine, som forebygger sygdommen hepatitis B.
English: Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Danish: Passende medicinsk behandling skal være let tilgængeligt i tilfælde af sjældent forekommende anafylaktiske reaktioner efter administration af vaccinen.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue
Danish: Tegn på en allergisk reaktion kan være kløende hududslæt, åndenød og hævelse af ansigt eller tunge.
English: If you miss a dose
Danish: Hvis du glemmer en injektion
English: Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans.
Danish: Farmakokinetiske egenskaber i mennesker er ikke undersøgt for Fendrix eller MPL alene.
English: Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine.
Danish: Kliniske undersøgelser med administration af 2.476 doser Fendrix til 82 præ-hæmodialyse og hæmodialyse patienter og til 713 raske personer ≥ 15 år muliggjorde dokumentation af vaccinens bivirkningsprofil.
English: Hepatitis B surface antigen1, 2, 3
Danish: Hepatitis B-overfladeantigen1, 2, 3
English: Hypersensitivity after previous administration of other hepatitis B vaccines.
Danish: Overfølsomhed efter tidligere administration af andre hepatitis B-vacciner.
English: • loss of feeling or problems moving some parts of your body
Danish: • nedsat følesans eller evne til at bevæge dele af kroppen
English: • The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit).
Danish: • Virus er til stede i kropsvæsker f.eks. vaginalsekret, blod, sæd eller spyt.
English: - First injection
Danish: - Første injektion
English: Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6).
Danish: Non-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle dyreundersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, kardiovaskulær og respiratorisk sikkerhedsfarmakologi og reproduktionstoksicitet herunder graviditet samt peri og postnatal udvikling af dyreunger frem til afvænning (se pkt.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: Som med alle andre vacciner, opnås et beskyttende immunrespons ikke nødvendigvis hos alle vaccinerede.
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Danish: Det kan forventes, at der ikke fremkaldes et tilstrækkeligt immunrespons hos patienter i immunsuppressiv behandling eller hos patienter med immundefekt.
English: Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Fendrix.
Danish: Serologisk testning skal overvejes hos personer, hvor der er risiko for ikke at opnå beskyttelse efter fuldendt vaccinationsprogram med Fendrix.
English: • stomach and digestion problems.
Danish: • mave- og fordøjelsesproblemer
English: Talk to your doctor or pharmacist before you are given Fendrix:
Danish: Kontakt lægen eller apotekspersonalet før du får Fendrix:
English: - 2 months after the first injection.
Danish: - 2 måneder efter den første injektion
English: Additionally, the following side effects have also been reported with other hepatitis B vaccines:
Danish: Følgende bivirkninger er desuden set for andre hepatitis B-vacciner:
English: These make the vaccine work quicker, better and last for longer.
Danish: Disse stoffer fremskynder, forbedrer og forlænger den beskyttende virkning af vaccinen.
English: Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.
Danish: Fendrix må ikke gives til personer med overfølsomhed overfor det aktive stof eller et af de øvrige indholdsstoffer.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut - 1330 Rixensart Belgium
Danish: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut - 1330 Rixensart Belgien
English: • Fendrix helps your body to produce its own protection against the virus (antibodies).
Danish: • Vaccinen virker ved at hjælpe kroppen til selv at producere beskyttelse (antistoffer) mod virus.
English: Shake well before use
Danish: Omrystes grundigt før brug
English: • patients who are going to have “haemo-dialysis” in the future.
Danish: • patienter, som i fremtiden vil have behov for hæmodialyse.
English: In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months.
Danish: I en stor dobbelt-blind randomiseret sammenlignelig undersøgelse, blev raske personer inkluderet til at modtage tre doser Fendrix i et primært vaccinationsprogram (n=713) eller en kommercielt tilgængelig hepatitis B-vaccine (n=238) ved måned 0, 1 og 2.
English: As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Danish: Da præ-hæmodialyse og dialyse patienter er særligt udsatte for HBV og har en større risiko for at blive kronisk inficerede, skal det overvejes at tage særlige forsigtighedsregler, dvs. indgift af boosterdosis for at sikre et beskyttende antistofniveau i henhold til nationale anbefalinger og retningslinjer.
English: • pain or discomfort where the injection was given.
Danish: • smerte eller ubehag på injektionsstedet
English: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Danish: Efter opbevaring kan et fint hvidt bundfald med en klar farveløs supernatant observeres.
English: Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients.
Danish: Anti-HBs-antistoffer har vist persistens i mindst 36 måneder efter et primært program med administration af Fendrix på dag 0, 1, 2, 6 måneder hos præ-hæmodialyse- og hæmodialysepatienter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/0299/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/0299/001
English: If concomitant administration of specific hepatitis B immunoglobulin and Fendrix is required, these should be given at different injection sites.
Danish: Hvis samtidig administration af specifik hepatitis Bimmunoglobulin og Fendrix er påkrævet, skal der anvendes forskellige injektionssteder.
English: Infections and infestations: Rare: viral infection
Danish: Infektioner og parasitære sygdomme: Sjælden: viral infektion
English: • feeling nervous
Danish: • nervøsitet
English: • Fendrix can only help to protect you against infection with the hepatitis B virus.
Danish: • Fendrix kan kun beskytte dig mod infektion med hepatitis B-virus.
English: Frequencies are reported as: Very common: (≥1/10) Common:
Danish: Hyppighederne er rapporteret som: Meget almindelig:
English: Vaccination should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the infant.
Danish: Der må kun vaccineres, hvis fordelene er større end mulige risici for barnet.
English: What Fendrix is and what it is used for What you need to know before you receive Fendrix How Fendrix is given
Danish: Virkning og anvendelse Det skal du vide, før du får Fendrix Sådan gives Fendrix
English: • The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice).
Danish: • De mest almindelige symptomer er milde influenza-lignende symptomer som hovedpine eller feber, udpræget træthed, mørkfarvet urin, lys afføring, gulfarvning af hud eller øjne (gulsot).
English: • Fendrix may not protect you from being ill if you have already caught the hepatitis B virus.
Danish: • Fendrix kan ikke forhindre, at du bliver syg, hvis du allerede er smittet med hepatitis B-virus.
English: • if you have any known allergies • if you have had any health problems after having a vaccine in the past.
Danish: • hvis du har haft problemer med helbredet efter tidligere vaccinationer.
English: Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Danish: Bivirkninger, som er rapporteret i en klinisk undersøgelse efter primærvaccination med Fendrix og betragtet som værende relateret til eller muligvis relateret til vaccination, er blevet kategoriseret efter hyppighed.
English: • other reactions where the injection was given.
Danish: • andre reaktioner på injektionsstedet
English: In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups was observed.
Danish: En reproduktionstoksicitets undersøgelse hos dyr, som inkluderede post-natal opfølgning indtil afvænning (se pkt.
English: Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Danish: Fendrix er indiceret til aktiv immunisering af voksne og unge fra 15 år med nyreinsufficiens (herunder præ-hæmodialyse- og hæmodialysepatienter) mod hepatitis B-infektion (HBV), forårsaget af alle kendte subtyper.
English: The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects.
Danish: Reaktogenicitetsprofilen for Fendrix hos 82 præ-hæmodialyse- og hæmodialysepatienter var generelt sammenlignelig med den set hos raske personer.
English: Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine.
Danish: Fendrix kan anvendes som boosterdosis efter et primært vaccinationsforløb med enten Fendrix eller øvrige kommercielt tilgængelige rekombinant hepatitis B-vacciner.
English: Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the foetus.
Danish: Der må kun vaccineres under graviditet, hvis fordelene er større end mulige risici for barnet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITH SEPARATE NEEDLE 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 FYLDT INJEKTIONSSPRØJTE MED SEPARAT KANYLE 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER
English: Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly reported and consisted of rigors, other injection site reaction and maculo-papular rash.
Danish: Spontane symptomer, som vurderes at have en mulig sammenhæng med vaccinationen blev usædvanligvis rapporteret og bestod af kulderystelser, andre reaktioner fra injektionsstedet og maculopapular udslæt.
English: Other medicines and Fendrix
Danish: Brug af anden medicin sammen med Fendrix
English: - Third injection
Danish: - Fjerde injektion
English: Immune system disorders: Rare: allergy
Danish: Immunsystemet: Sjælden: allergi
English: • Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
Danish: • Fendrix fås i pakninger med 1 injektionssprøjte med eller uden separat nål og i en pakning med 10 injektionssprøjter uden nåle.
English: • Fendrix may need to be given at the same time as an injection of hepatitis B “immuno-globulins”.
Danish: • Det kan være nødvendigt at give Fendrix samtidigt med hepatitis B-immunglobuliner.
English: • This means they can still infect other people and are known as virus “carriers”.
Danish: • Disse mennesker kan smitte andre og kaldes hepatitis B-smittebærere.
English: After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.
Danish: Efter fuldførelse af det primære vaccinationsprogram på fire doser (dvs. ved måned 7) var 90,9 % af Fendrix modtagerne serobeskyttet (≥ 10 mIE/ml) mod hepatitis B, til sammenligning med 84,4 % i en kontrolgruppe, som modtog en kommercielt tilgængelig hepatitis B-vaccine.
English: 0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type I glas) med en propstopper (butylgummi) med eller uden kanyle i en pakningsstørrelse på 1, eller uden separate kanyle i en pakningsstørrelse på 10. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated.
Danish: Der findes ingen data vedrørende samtidig administration af Fendrix og andre vacciner eller specifik hepatitis B-immunoglobulin (HBIg).
English: In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.
Danish: I en sammenlignende klinisk undersøgelse med 165 præ-hæmodialyse og hæmodialyse patienter (15 år og opefter) opnåedes beskyttende niveau af specifikke humorale antistoffer (anti-HBs-titre ≥ 10 mIE/ml) hos 74,4 % i Fendrix gruppen (n= 82) en måned efter tredje dosis (dvs. ved måned 3), sammenlignet med 52,4 % i kontrol gruppen, som modtog en dobbelt dosis af en kommercielt tilgængelig hepatitis B-vaccine (n= 83).
English: If you are not sure, talk to your doctor or pharmacist before having Fendrix.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, inden du får Fendrix.
English: At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.
Danish: Ved 36. måned havde 80,4 % af disse patienter stadig et beskyttende antistofniveau (anti-HBs-titer ≥ 10 mIE/ml), sammenlignet med 51,3 % i gruppen af patienter, som modtog en kommercielt tilgængelig hepatitis B-vaccine.
English: Gastrointestinal disorders: Common: gastrointestinal disorder
Danish: Mave-tarm-kanalen: Almindelig: gastrointestinale gener
English: There are no data from use of Fendrix during lactation.
Danish: Der er ingen data fra brugen af Fendrix i forbindelse med amning.
English: The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in prehaemodialysis and haemodialysis patients.
Danish: Reaktogenicitetsprofilen for Fendrix hos raske forsøgspersoner var generelt sammenlignelig med bivirkningsprofilen set hos præ-hæmodialyse- og hæmodialysepatienter.
English: • As with all vaccines, a course of Fendrix cannot fully protect all people that are vaccinated.
Danish: • Lige som for andre vacciner beskytter Fendrix ikke alle personer, som er vaccineret med det primære vaccinationsprogram.
English: Psychiatric disorders: Rare: nervousness
Danish: Psykiske forstyrrelser: Sjælden: nervøsistet
English: • Fendrix contains two things called “MPL” (a non-toxic purified fat derivative from bacteria) and
Danish: • Vaccinen indeholder to stoffer, ”MPL” (et ikke-toksisk oprenset lipid fra bakterier) og ”aluminiumphosphat”.
English: • Keep this vaccine out of the sight and reach of children.
Danish: • Opbevar vaccinen utilgængeligt for børn.
English: • Store in the original package in order to protect from light.
Danish: • Opbevares i den originale pakning for at beskytte mod lys
English: Rare: vertigo
Danish: Øre og labyrint: Sjælden: vertigo
English: The vaccine may not prevent hepatitis B infection in such cases.
Danish: I sådanne tilfælde er det ikke sikkert, at vaccinen kan forebygge hepatitis B-infektion.
English: Pharmacotherapeutic group: Vaccines, hepatitis vaccines, ATC code J07BC01.
Danish: Farmakoterapeutisk klassifikation: Vacciner, hepatitisvacciner, ATC-kode: J07BC01 Fendrix inducerer specifikke humorale antistoffer mod HBsAg (anti-HB-antistoffer).
English: How Fendrix works
Danish: Sådan virker Fendrix
English: What is hepatitis B?
Danish: Hepatitis B
English: Carriers of hepatitis B
Danish: Hepatitis B-smittebærere
English: Clinical trial data
Danish: Kliniske data
English: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100)
Danish: (≥ 1/1000 til < 1/100)
English: Fendrix should not be given
Danish: Du må ikke få Fendrix:
English: • Suspension for injection in a prefilled syringe.
Danish: • Injektionsvæske, suspension i fyldt injektionssprøjte.
English: Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency.
Danish: Bivirkninger rapporteret i kliniske undersøgelser efter et primært vaccinationsforløb med Fendrix, som vurderes at have en mulig relation til vaccinationen er kategoriseret efter frekvens.
English: Uncommon: other injection site reaction Rare: rigors, hot flushes, thirst, asthenia
Danish: Ikke almindelig: andre reaktioner på injektionsstedet Sjælden: kulderystelser, hedeture, tørst, asteni
English: • numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy).
Danish: • følelsesløshed eller svaghed i arme og ben, nervebetændelse, svaghed og lammelser i arme og ben, men som også hyppigt breder sig til bryst og ansigt (Guillain-Barré syndrom).
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Danish: 50 mikrogram2adsorberet på aluminiumphosphat (0,5 milligram Al3+ totalt) 3produceret på gærceller (Saccharomyces cerevisiae) ved hjælp af rekombinant DNA-teknologi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 2. februar 2005
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Danish: 50 mikrogram2adsorberet på aluminiumphosphat (0,5 milligram Al3+ totalt) 3produceret på gærceller (Saccharomyces cerevisiae) ved hjælp af rekombinant DNA-teknologi.
English: Primary immunisation:
Danish: Primært vaccinationsprogram: