FrancophonIA/ELRC3.0 huggingface dataset:
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis, and Hib vaccines.
Danish: I sådanne tilfælde skal pertussis-vaccinationen afbrydes, og vaccinationsforløbet bør fortsættes med vacciner mod difteri, tetanus, hepatitis B, poliomyelitis og Hib.
English: One dose (0.5 mL) contains:
Danish: En dosis (0,5 ml) indeholder:
English: The anterolateral aspect of the thigh is the preferred site for infants under one year of age.
Danish: Den anterolaterale del af låret er det bedste injektionssted hos børn under 1 år.
English: • Very common side effects (may affect more than 1 in 10 people) are: decreased appetite irritability crying vomiting sleepiness or drowsiness fever (temperature 38°C or higher) pain, redness, swelling at the injection site
Danish: • Meget almindelige bivirkninger (kan ramme mere end 1 ud af 10 personer) er: nedsat appetit irritabilitet gråd opkastning søvnighed eller døsighed feber (temperatur på 38 °C eller mere) smerter, rødmen, hævelse på injektionsstedet
English: • Tetanus (often called lock jaw): caused by the tetanus bacteria entering a deep wound.
Danish: • Stivkrampe (også kaldet for tetanus): Stammer fra tetanus-bakterier, der kommer ind gennem et dybt sår.
English: Tetanus Toxoid
Danish: Tetanustoksoid
English: Long-term persistence of antibodies to pertussis antigens The persistence of pertussis antibodies was measured in children 4 or 5 years of age who had received Vaxelis at 2, 4 and 11-12 months of age.
Danish: Langtidsdata for antistofpersistens mod pertussis-antigener Antistofpersistensen mod pertussis blev målt hos børn i 4- eller 5-års alderen, som havde fået Vaxelis i 2-, 4- og 11-12-måneders alderen.
English: Fever ≥39.5°C was observed in 3.7% of children (postbooster) and 0.2% to 0.8% of children (post-primary) receiving Vaxelis with PCV13 (see sections 4.4 and 4.5).
Danish: Der blev observeret feber på ≥ 39,5 °C hos 3,7% af børnene (efter booster-dosen) og 0,2% til 0,8% af børnene (efter den primære dosis), der fik Vaxelis med PCV13 (se pkt.
English: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden.
Danish: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden, Holland
English: Vaccine response: If pre-Dose 1 antibody concentration < lower limit of quantification (LLOQ), then the post-vaccination series antibody concentration was ≥ LLOQ; if pre-Dose 1 antibody concentration ≥ LLOQ, then the post-vaccination series antibody concentration was ≥ pre-Dose 1 levels.
Danish: Vaccinerespons: Hvis antistofkoncentrationen inden dosis 1 var < den nedre kvantificeringsgrænse (LLOQ), så var antistofkoncentrationen efter vaccinationsserien ≥ LLOQ; hvis antistofkoncentrationen inden dosis 1 var ≥ LLOQ, så var antistofkoncentrationen efter vaccinationsserien ≥ koncentrationen inden dosis 1.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Prior to administration, the pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Danish: Inden administration skal den fyldte injektionssprøjte omrystes forsigtigt for at opnå en homogen, hvidlig, uklar suspension.
English: Hepatitis B surface antigen
Danish: Hepatitis B-overfladeantigen
English: Conjugated to meningococcal protein
Danish: Konjugeret til meningokokprotein
English: Vaxelis will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Danish: Vaxelis beskytter ikke mod sygdomme, der skyldes andre patogener end Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B-virus, poliovirus eller Haemophilus influenzae type b. Det kan dog forventes, at hepatitis D vil blive forebygget ved immunisering, idet hepatitis D (forårsaget af delta-virus) ikke forekommer, når hepatitis B-infektion er fraværende.
English: Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.
Danish: Pakningsstørrelser med 1 eller 10 fyldte injektionssprøjter uden påsat kanyle, med 1 separat kanyle eller med 2 separate kanyler.
English: Vaxelis should only be administered by intramuscular (IM) injection.
Danish: Vaxelis må kun administreres som en intramuskulær (i.m.)
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Danish: Vaccinen kan indeholde spor af glutaraldehyd, formaldehyd, neomycin, streptomycin og polymyxin B.
English: Uncommon Rash, hyperhidrosis
Danish: Ikke almindelig Udslæt, hyperhidrose
English: • Uncommon side effects (may affect up to 1 in 100 people) are: rash warmth, rash at the injection site increased appetite stomach pain excessive sweating cough nasal congestion and runny nose paleness sleep disorders including inability to get adequate sleep restlessness swollen glands in the neck, armpit or groin feeling tired floppy
Danish: • Ikke almindelige bivirkninger (kan ramme op til 1 ud af 100 personer) er: udslæt varme, udslæt på injektionsstedet øget appetit mavepine øget svedtendens hoste stoppet næse og næse, der løber bleghed søvnforstyrrelser, herunder mangel på tilstrækkelig søvn rastløshed hævede kirtler på halsen, i armhulerne eller lysken træthed slaphed
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Danish: Haemophilus influenzae type b polysaccharid (polyribosylribitolphosphat)
English: Vaxelis is for intramuscular injection only.
Danish: Vaxelis er kun beregnet til intramuskulær injektion.
English: For adjuvants, see section 2.
Danish: For hjælpestoffer, se pkt.
English: 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al produced in yeast (Saccharomyces cerevisiae) by recombinant DNA technology produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Danish: 50 mikrogram adsorberet på aluminiumphosphat (0,17 mg Al adsorberet på amorf aluminiumhydroxyphosphatsulfat (0,15 mg Al fremstillet i gærceller (Saccharomyces cerevisiae) ved hjælp af rekombinant DNA- teknologi fremstillet i Vero-celler eller en ækvivalent antigen-mængde, der er fastlagt efter en egnet immunokemisk metode.
English: No data are available in older children (see sections 4.8 and 5.1)
Danish: Der foreligger ingen data fra ældre børn (se pkt.
English: Name and address of the manufacturers of the biological active substances Merck Sharp and Dohme Corporation 770 Sumneytown Pike
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Merck Sharp and Dohme Corporation
English: cried continuously and could not be comforted for more than 3 hours within 48 hours of vaccination.
Danish: Barnet har grædt uafbrudt og utrøsteligt i mere end 3 timer inden for 48 timer efter en vaccination.
English: The pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Danish: Den fyldte injektionssprøjte skal omrystes forsigtigt for at opnå en homogen, hvidlig, uklar suspension.
English: • swelling of the face or throat
Danish: • hævelse i ansigt eller svælg
English: 2, 4, 6 months
Danish: 2, 4, 6 mdr.
English: • Pertussis (often called whooping cough): a highly infectious illness that affects the airways.
Danish: • Kighoste (pertussis): En særdeles smitsom sygdom, der rammer luftvejene.
English: Vaccine response: If pre-Dose 1 antibody concentration < LLOQ, then post-booster antibody concentration should be ≥ LLOQ; If pre-Dose 1 antibody concentration ≥ LLOQ, then the post-booster antibody concentration should be ≥ pre
Danish: Vaccinerespons: Hvis antistofkoncentrationen inden dosis 1 var < LLOQ, så bør antistofkoncentrationen efter boosterdosen være ≥ LLOQ; hvis antistofkoncentrationen inden dosis 1 var ≥ LLOQ, så bør antistofkoncentrationen efter booster-dosen være ≥ koncentrationen inden dosis 1.
English: Three doses
Danish: Tre doser
English: • is allergic (hypersensitive) to Vaxelis vaccine or any diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines, to any ingredients listed in section 6, to neomycin, streptomycin or polymyxin B (antibiotics), glutaraldehyde or formaldehyde, as these substances are used during the manufacturing process.
Danish: • Er allergisk over for Vaxelis-vaccinen eller vacciner mod difteri, stivkrampe, kighoste, poliomyelitis, hepatitis B eller Hib, over for et af de øvrige indholdsstoffer (angivet i afsnit 6), over for neomycin, streptomycin eller polymyxin B (antibiotika), glutaraldehyd eller formaldehyd, da disse stoffer anvendes i fremstillingsprocessen.
English: The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established.
Danish: Vaxelis' sikkerhed og virkning hos børn i alderen 0-6 uger er ikke klarlagt.
English: • has had shortness of breath or swelling of the face (anaphylactic reaction) after administration of a previous dose of Vaxelis.
Danish: • Har fået stakåndethed eller hævelse i ansigtet (anafylaktisk reaktion), efter at det tidligere har fået en dosis Vaxelis.
English: 1 dose (0.5 ml):
Danish: 1 dosis (0,5 ml):
English: Carton for prefilled syringe without needle, with one separate needle, with two separate needles.
Danish: Karton til fyldt injektionssprøjte uden kanyle, med én separat kanyle, med to separate kanyler.
English: Vaxelis is a vaccine, which helps to protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Vaxelis is given to children from the age of six weeks.
Danish: Vaxelis er en vaccine, der er med til at beskytte dit barn mod difteri, stivkrampe, kighoste, hepatitis B, poliomyelitis og alvorlige sygdomme, der skyldes Haemophilus influenzae type b. Vaxelis gives til børn fra 6-ugers-alderen.
English: 32 D antigen units
Danish: 32 D-antigen-enheder
English: The persistence of antibody to hepatitis B surface antigen (anti-HBsAg) was measured in children 4 or 5 years of age who had received Vaxelis either at 2, 4 and 11-12 months or at 2, 3, 4 and 12 months of age.
Danish: Langtidsdata for antistofpersistens mod hepatitis B-overfladeantigen Antistofpersistensen mod hepatitis B-overfladeantigen (anti-HBsAg) blev målt hos børn i 4- eller 5-års alderen, som havde fået Vaxelis i enten 2-, 4- og 11-12-måneders alderen eller i 2-, 3-, 4- og 12måneders alderen.
English: • has any problems with bleeding for a long time after minor cuts, or bruises easily.
Danish: • Barnet har blødt i lang tid efter små rifter, eller barnet får nemt blå mærker.
English: Diphtheria Toxoid not less than 20 IU
Danish: Difteritoksoid ikke under 20 IE
English: Anti-diphtheria (≥ 0.1 IU/mL) Anti-tetanus (≥ 0.1 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response) Anti-FIM (vaccine response) Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution) Anti-HBs Ag (≥ 10 mIU/mL)
Danish: Antidifteri (≥ 0,1 IE/ml) Antitetanus (≥ 0,1 IE/ml) Anti-PT (vaccinerespons) Anti-FHA (vaccinerespons) Anti-PRN (vaccinerespons) Anti-FIM (vaccinerespons) Antipolio type 1 (fortynding ≥ 1:8) Antipolio type 2 (fortynding ≥ 1:8) Antipolio type 3 (fortynding ≥ 1:8) Anti-HBs Ag (≥ 10 mIE/ml)
English: Injection site erythema, injection site pain, injection site swelling Pyrexia
Danish: Erythem på injektionsstedet, smerter på injektionsstedet, hævelse på injektionsstedet Pyreksi
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Danish: Kighoste kan også forårsage mellemørebetændelse, bronkitis som kan vare i lang tid, lungebetændelse, kramper, hjerneskade og dødsfald.
English: 8 D antigen units
Danish: 8 D-antigen-enheder
English: Suspension for injection 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
Danish: Injektionsvæske, suspension 1 fyldt injektionssprøjte (0,5 ml) uden kanyle 10 fyldte injektionssprøjter (0,5 ml) uden kanyle 1 fyldt injektionssprøjte (0,5 ml) med 1 kanyle 10 fyldte injektionssprøjter (0,5 ml) med 10 kanyler 1 fyldt injektionssprøjte (0,5 ml) med 2 kanyler 10 fyldte injektionssprøjter (0,5 ml) med 20 kanyler
English: România Merck Sharp & Dohme Romania S.R.L.
Danish: Merck Sharp & Dohme Romania S.R.L.
English: Your doctor will advise you whether your child should receive Vaxelis.
Danish: Lægen vil fortælle, om barnet bør få Vaxelis.
English: Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Danish: Vaxelis (DTaP-HB-IPV-Hib) er indiceret til anvendelse som primær vaccination og boostervaccination til spædbørn og småbørn fra 6-ugers-alderen mod difteri, tetanus, pertussis, hepatitis B, poliomyelitis og invasive sygdomme, der skyldes Haemophilus influenzae type b (Hib).
English: • Common side effects (may affect up to 1 in 10 people) are: diarrhoea hard mass, lump (nodule) at the injection site bruising at the injection site
Danish: • Almindelige bivirkninger (kan ramme op til 1 ud af 10 personer) er: diaré en hård klump eller knude på injektionsstedet blå mærker på injektionsstedet
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Danish: Difteri, tetanus, pertussis (acellulær, komponentvaccine), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus type b konjugatvaccine (adsorberet).
English: If your child misses a dose of Vaxelis
Danish: Hvis en dosis Vaxelis bliver glemt
English: Blood disorders
Danish: Blodsygdomme
English: 40 D antigen units
Danish: 40 D-antigen-enheder
English: (1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: (1/10.000 til <1/1.000)
English: Vaxelis may be administered simultaneously with pneumococcal polysaccharide conjugate vaccines, rotavirus vaccines, measles, mumps, rubella (MMR) and varicella containing vaccines and meningococcal C conjugate vaccines.
Danish: Vaxelis kan administreres samtidig med konjugerede pneumokok-polysaccharid-vacciner, rotavirusvacciner, mæslinger, fåresyge og rubella (MFR) samt varicella-holdige vacciner og konjugerede meningokok C-vacciner.
English: Carton for prefilled syringes without needle.
Danish: Karton til fyldte injektionssprøjter uden kanyle.
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.3).
Danish: Vaccinen kan indeholde spor af glutaraldehyd, formaldehyd, neomycin, streptomycin og polymyxin B, som anvendes i fremstillingsprocessen (se pkt.
English: Suspension for injection Multipack: 50 (5 packs of 10) pre-filled syringes (0.5 mL) without needle
Danish: Injektionsvæske, suspension Multipakning: 50 (5 pakninger á 10) fyldte injektionssprøjter (0,5 ml) uden kanyle
English: 2, 3, 4 months
Danish: 2, 3, 4 mdr.
English: Carton for multipack containing 5 packs of 10 prefilled syringes without needle.
Danish: Karton til multipakning med 5 pakninger á 10 fyldte injektionssprøjter uden kanyle.
English: had a fit (convulsions) with or without fever, within 3 days of vaccination.
Danish: Barnet har haft krampeanfald med eller uden feber inden for 3 dage efter en vaccination.
English: Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella-varicella (MMRV) vaccines, rotavirus vaccines or meningococcal C vaccines.
Danish: Vaxelis kan gives samtidig med andre vacciner såsom pneumokok-vacciner, MFR-vacciner (mæslinger, fåresyge og røde hunde), rotavirus-vacciner og meningokok C-vacciner.
English: Suspension for injection 10 pre-filled syringes (0.5 ml) without needle
Danish: Injektionsvæske, suspension 10 fyldte injektionssprøjter (0,5 ml) uden kanyle
English: Robert Boyleweg 4 2333 CG Leiden.
Danish: Robert Boyleweg 4 2333 CG Leiden Holland
English: Uncommon (1/1,000 to <1/100)
Danish: (1/1.000 til <1/100)
English: Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:
Danish: Andre bivirkninger, der ikke er anført herover, er blevet indberettet for andre vacciner mod difteri, stivkrampe, kighoste, poliomyelitis, hepatitis B eller Hib:
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse MCM Vaccine B.V.
English: Additional injections (booster)
Danish: Yderligere injektioner (opfølgning)
English: Multipack of 5 packs of 10 pre-filled syringes with no needle.
Danish: Multipakning med 5 pakninger á 10 fyldte injektionssprøjter uden kanyle.
English: Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Danish: Vaxelis injektionsvæske, suspension i fyldt injektionssprøjte Difteri, tetanus, pertussis (acellulær, komponentvaccine), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus type b konjugatvaccine (adsorberet)
English: Vaxelis is provided as a suspension for injection in pre-filled syringe.
Danish: Vaxelis leveres som en injektionsvæske, suspension i en fyldt injektionssprøjte.
English: • episodes of shock-like state or paleness, floppy and unresponsive
Danish: • krampeanfald med eller uden feber • episoder med shock-lignende tilstand eller bleghed, slaphed og passivitet
English: 3 micrograms
Danish: 3 mikrogram
English: INSTRUCTIONS ON USE
Danish: Instruktioner vedrørende anvendelsen
English: Hrvatska Merck Sharp & Dohme d.o.o.
Danish: Merck Sharp & Dohme d.o.o.
English: 2, 4 months
Danish: 2, 4 mdr.
English: Two doses
Danish: To doser
English: What Vaxelis is and what it is used for What you need to know before Vaxelis is given to your child How to use Vaxelis
Danish: Det skal du vide, før dit barn vaccineres med Vaxelis Sådan bliver dit barn vaccineret med Vaxelis Bivirkninger
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin, and polymyxin B).
Danish: 6.1 eller over for spor af residualstoffer (glutaraldehyd, formaldehyd, neomycin, streptomycin og polymyxin B).
English: Uncommon Pallor
Danish: Ikke almindelig Bleghed
English: Vaxelis suspension for injection in pre-filled syringe
Danish: Vaxelis injektionsvæske, suspension i fyldt injektionssprøjte
English: Uncommon Injection site rash, injection site warmth, fatigue c- Description of selected adverse reactions
Danish: Almindelig Blå mærker på injektionsstedet, induration på injektionsstedet, knude på injektionsstedet Ikke almindelig Udslæt på injektionsstedet, varme på injektionsstedet, træthed c- Beskrivelse af udvalgte bivirkninger
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - multipack of 5 packs of 10.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type 1-glas) med stempelstopper (butyl) og beskyttelseshætte (butyl) uden kanyle - multipakning med 5 pakninger á 10.
English: Uncommon Lymphadenopathy
Danish: Ikke almindelig Lymfadenopati
English: • extensive swelling of the vaccinated limb
Danish: • kraftig hævelse i det vaccinerede område (arm eller ben)
English: Excipients:
Danish: • udslæt
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - pack size of 1 or 10.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type 1-glas) med stempelstopper (butyl) og beskyttelseshætte (butyl) uden kanyle - pakningsstørrelse med 1 eller 10.
English: Vaxelis suspension for injection in pre-filled syringe.
Danish: Vaxelis injektionsvæske, suspension i fyldt injektionssprøjte.
English: Very Common Vomiting Common
Danish: Meget almindelig
English: th and 5
Danish: 4.8 og 5.1)
English: Vaxelis injection
Danish: injektion.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Ikke almindelig Hoste Mave-tarm-kanalen
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 2 separate needles - pack size of 1 or 10.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type 1-glas) med stempelstopper (butyl) og beskyttelseshætte (butyl) med 1 separat kanyle - pakningsstørrelse med 1 eller 10. 0,5 ml suspension i fyldt injektionssprøjte (type 1-glas) med stempelstopper (butyl) og beskyttelseshætte (butyl) med 2 separate kanyler - pakningsstørrelse med 1 eller 10
English: b- Tabulated list of adverse reactions
Danish: b- Skema over bivirkninger
English: Very Common Somnolence Uncommon Hypotonia
Danish: Ikke almindelig Hypotoni
English: With hepatitis B vaccination at birth Without hepatitis B vaccination at birth Anti-PRP (≥ 0.15 µg/mL)
Danish: Uden hepatitis Bvaccination ved fødslen
English: Posology
Danish: Somnolens
English: What you need to know before Vaxelis is given to your child
Danish: Det skal du vide, før dit barn vaccineres med Vaxelis
English: If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om vedrørende anvendelsen af denne vaccine.
English: MA (EU) number
Danish: MF (EU)-nummer Navn
English: 1 pre-filled syringe in a blister + 2 alcohol pads
Danish: 1 fyldt injektionssprøjte i et blister + 2 alkoholservietter
English: 1 pre-filled pen in a blister + 2 alcohol pads
Danish: 1 fyldt pen i et blister +
English: Survival (months)
Danish: Overlevelse (måneder)
English: This can even be life threatening.
Danish: Dette kan være livstruende.
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 28 May 2015
Danish: Dato for første markedsføringstilladelse:10 juni 2010 Dato for seneste fornyelse: 28 maj 2015
English: This increase is considered unlikely to be of clinical relevance.
Danish: Det anses for usandsynligt, at denne stigning har klinisk relevans.
English: Reactions have been mild and have not generally required specific therapy.
Danish: Reaktionerne har været milde og har generelt ikke krævet speciel behandling.
English: • if your blood cell counts are too low.
Danish: • hvis dine blodtal er for lave.
English: EXP: Use immediately after opening.
Danish: EXP: Anvendes umiddelbart efter åbningen.
English: In some cases you may need a blood transfusion.
Danish: I nogle tilfælde kan det blive nødvendigt med en blodtransfusion.
English: Study results Study GOG-0179
Danish: Resultater fra studie GOG-0179
English: 1316 BN, Almere The Netherlands
Danish: 1316 BN, Almere Holland eller
English: After first opening
Danish: Efter åbning
English: CI = Confidence interval.
Danish: CI = konfidensinterval.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Danish: Den gennemsnitlige halveringstid steg fra 1,9 time til 4,9 timer.