FrancophonIA/ELRC3.0 huggingface dataset:
English: After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Danish: Efter en komplet vaccination i henhold til en 2-dosis primær vaccination og en boosterdosis med Infanrix hexa havde mindst 97,9 % af personerne udviklet serobeskyttende eller seropositivt antistofniveau mod hver af vaccines antigener.
English: Powder and suspension for suspension for injection.
Danish: Pulver og suspension til injektionsvæske, suspension.
English: Uncommon Upper respiratory tract infection
Danish: Ikke almindelig Infektion i de øvre luftveje
English: Anti-FHA (5 EL.U/ml)
Danish: Anti-FHA (5 EL.E/ml)
English: How to store Infanrix hexa
Danish: Sådan får dit barn Infanrix hexa
English: Anti-PT (5 EL.U/ml)
Danish: Anti-PT (5 EL.E/ml)
English: What Infanrix hexa is and what it is used for What you need to know before your child receives Infanrix hexa How Infanrix hexa is given
Danish: Virkning og anvendelse Det skal du vide, før dit barn får Infanrix hexa Sådan får dit barn Infanrix hexa Bivirkninger
English: months N= 1055 (6 studies)
Danish: måneder n= 1.055 (6 studier)
English: Anti-PRN (5 EL.U/ml)
Danish: Anti-PRN (5 EL.E/ml)
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Efter rekonstitution, 1 dosis (0,5 ml) Difteritoksoid1
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Danish: Procentdel af personer med antistoftiter, der er indikativ for seroprotektion/ seropositivitet en måned efter 2-dosis primærvaccination og boosterdosis med Infanrix hexa
English: • Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet, må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: 1 dose (0.5 ml)
Danish: 10 x 1 dosis (0,5 ml)
English: Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8).
Danish: Data fra et klinisk studie indikerer, at når Infanrix hexa administreres samtidig med MFRV-vaccine, er hyppigheden af febrile reaktioner højere, end når Infanrix hexa administreres alene, og svarende til hyppigheden efter administration af MFRV-vaccine alene (se pkt.
English: How Infanrix hexa works
Danish: Sådan virker Infanrix hexa
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Infanrix hexa må ikke uden kompatibilitetsstudier blandes med andre lægemidler i den samme sprøjte.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Danish: Procentdelen af personer med en antistoftiter, der er indikativ for seroprotektion / seropositivitet en måned efter 3-dosis-primærvaccination og boosterdosis med Infanrix hexa
English: The immunogenicity of Infanrix hexa was evaluated across three studies including approximately 300 preterm infants (born after a gestation period of 24 to 36 weeks) following a 3-dose primary vaccination course at 2, 4 and 6 months of age.
Danish: Immunogeniciteten af Infanrix hexa efter et primært vaccinationsprogram med 3 doser ved henholdsvis 2, 4- og 6-måneders-alderen blev evalueret på tværs af 3 studier med ca. 300 præmature spædbørn (født mellem 24. og 36. svangerskabsuge).
English: 10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Danish: 10 hætteglas og 10 fyldte injektionssprøjter 10 x 1 dosis (0,5 ml)
English: Lactose anhydrous
Danish: Vandfri lactose
English: Suspension for suspension for injection
Danish: Beskyttelsehætte for injektionssprøjten
English: (polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Danish: (polyribosylribitolphosphat, PRP)3 konjugeret til tetanustoksoid som bærerprotein ca. 25 mikrogram
English: To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see picture).
Danish: Kanylen sættes på injektionssprøjten ved at skrue kanylen med uret, indtil man har en fornemmelse af,
English: (polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Danish: (polyribosylribitolphosphat)2 konjugeret til tetanustoksoid som bærerprotein ca. 25 mikrogram
English: Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
Danish: Del af en multipakning indeholdende 5 pakninger, med hver 10 hætteglas og 10 fyldte injektionssprøjter uden kanyler.
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Danish: Difteri (D), tetanus (T), pertussis (acellulær, komponent) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inaktiveret) (IPV) og Haemophilus influenzae type b (Hib) konjugeret vaccine (adsorberet).
English: After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Danish: Efter en boostervaccination (efter 4. dosis) havde mindst 98,4 % af børnene udviklet serobeskyttende eller seropositivt antistofniveau mod alle vaccinens antigener.
English: Dermatitis
Danish: Dosering
English: Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone.
Danish: Data fra kliniske studie indikerer, at hyppigheden af febrile reaktioner er højere, når Infanrix hexa administreres samtidig med konjugerede pneumokokvacciner, sammenlignet med forekomsten, når Infanrix hexa administreres alene.
English: (polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Danish: (polyribosylribitolphosphat)3 konjugeret til tetanustoksoid som bærerprotein ca. 25 mikrogram
English: - neomycin or polymyxin (antibiotics).
Danish: 6.1 eller formaldehyd, neomycin eller polymyxin.
English: Anti-tetanus (0.1 IU/ml) †
Danish: Anti-tetanus (0,1 IE/ml) †
English: Infanrix hexa should not be given:
Danish: Infanrix hexa indeholder: Aktive stoffer:
English: Anti-tetanus (0.1 IU/ml)
Danish: Anti-tetanus (0,1 IE/ml)
English: each containing 10 vials and 10 pre-filled syringes, without needles.
Danish: pakninger indeholdende hver 10 hætteglas og 10 fyldte injektionssprøjter uden nåle.
English: If any of the following events are known to have occurred in temporal relation to receipt of pertussiscontaining vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered: Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination; Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination.
Danish: Temperatur på ≥ 40,0 °C inden for 48 timer efter vaccination, uden anden kendt årsag; Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode) inden for 48 timer efter vaccinationen;
English: Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section
Danish: Som forventet for denne population er der dog observeret et lavere immunrespons over for nogle antigener (se pkt.
English: After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Danish: Efter et 2-dosis primært vaccinationsprogram havde mindst 84,3 % af spædbørnene udviklet serobeskyttende eller seropositivt antistofniveau mod hver af vaccinens antigener.
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Danish: Infanrix hexa, pulver og suspension til injektionsvæske, suspension i fyldt injektionssprøjte Difteri (D), tetanus (T), pertussis (acellulær komponent) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inaktiveret) (IPV) og Haemophilus influenzae type b (Hib) konjugeret vaccine (adsorberet)
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Danish: Infanrix hexa, pulver og suspension til injektionsvæske, suspension i fyldt injektionssprøjte Difteri (D), tetanus (T), pertussis (acellulær, komponent) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inaktiveret) (IPV) og Haemophilus influenzae type b (Hib) konjugeret vaccine (adsorberet).
English: After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Danish: Efter et 3-dosis-vaccinationsprogram havde mindst 95,7 % af spædbørnene udviklet serobeskyttende eller seropositivt antistofniveau mod alle vaccinens antigener.
English: 1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
Danish: 1 hætteglas og 1 fyldt injektionssprøjte 1 dosis (0,5 ml)
English: Remove the needle protector, which on occasion can be a little stiff.
Danish: Den kan af og til være lidt stram.
English: N=2009 (12 studies)
Danish: n=2.009 (12 studier)
English: Infanrix hexa should not be given if any of the above apply to your child.
Danish: Hvis noget af ovenstående gælder for dit barn, bør Infanrix hexa ikke gives.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Danish: Procentdelen af personer med en antistoftiter, der viser serobeskyttelse/seropositivitet en måned efter primærvaccination og boosterdosis med Infanrix hexa
English: • Keep this vaccine out of the sight and reach of children.
Danish: • Opbevar lægemidlet utilgængeligt for børn.
English: Bleeding or bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B vaccines.
Danish: Der er indberettet tilfælde med hepatitis B-vacciner, hvor man nemmere bløder eller får blå mærker (trombocytopeni).
English: Anti-diphtheria (0.1 IU/ml) †
Danish: Anti-difteri (0,1 IE/ml) †
English: България ГлаксоСмитКлайн ЕООД
Danish: ГлаксоСмитКлайн ЕООД Тел.
English: Anti-diphtheria (0.1 IU/ml)
Danish: Anti-difteri (0,1 IE/ml)
English: • fits - this may be when they have a fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough.
Danish: Disse bivirkninger er set meget sjældent både efter Infanrix hexa og efter andre vacciner mod kighoste.
English: Powder for suspension for injection
Danish: Pulver til injektionsvæske, suspension i.m.
English: Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
Danish: Multipakning indeholdende 5 pakninger, med hver 10 hætteglas og 10 fyldte injektionssprøjter uden kanyler.
English: Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
Danish: Infanrix hexa gives som dyb intramuskulær injektion.
English: Ireland
Danish: България
English: GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 9218 111
Danish: Tel:+ 39 (0)45 9218 111
English: Syringe plunger
Danish: Hib-pulver:
English: The active substances are: Diphtheria toxoid1
Danish: Difteritoksoid1
English: GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
Danish: Tel: +40 (0)21 3028 208
English: 10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Danish: 10 hætteglas og 10 fyldte injektionssprøjter + 20 kanyler
English: Oral Drops, Solution Oral Use
Danish: Orale dråber, suspension
English: Human Medicines Evaluation Division
Danish: Bilag I Fortegnelse over lægemidler og lægemiddelformer
English: Film-Coated Tablet Oral Use
Danish: Filmovertrukket tablet
English: These changes usually resolve over time.
Danish: Disse forandringer forsvinder som regel over tid.
English: The study protocol should be submitted within 3 months of the EC decision.
Danish: Studieprotokollen skal indsendes inden for 3 måneder efter EF-afgørelsen.
English: Other side effects that you may experience with this medicine include:
Danish: Andre bivirkninger, som du kan opleve med denne medicin, omfatter:
English: As with all therapeutic proteins, there is potential for immunogenicity.
Danish: Som med alle terapeutiske proteiner er der potentiale for immunogenicitet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1022/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1022/001
English: Each course lasts one month.
Danish: Hvert behandlingsforløb varer en måned.
English: Your doctor or nurse will check you during and after the infusion.
Danish: Din læge eller sygeplejerske undersøger dig under og efter infusionen.
English: The terminal halflife was estimated at 10 (+ 6) days.
Danish: Den terminale halveringstid var vurderet til at være 10 (+ 6) dage.
English: A risk for interactions with concomitantly used medicinal products cannot be excluded.
Danish: En risiko for interaktioner med samtidigt anvendte lægemidler kan ikke udelukkes.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser for det brugsklare produkt brugerens ansvar.
English: However, the presence of HACA appears to increase the clearance of dinutuximab by approximately 60%.
Danish: Forekomst af HACA øger dog tilsyneladende clearance af dinutuximab med ca. 60 %.
English: The doctor or nurse will throw away medicines you no longer use.
Danish: Lægen eller sygeplejersken vil smide eventuel medicin, som du ikke længere bruger, væk.
English: Occasionally a young person who is taking this medicne may be reading the package leaflet, but usually it will be a parent/carer.
Danish: Det vil indimellem være et ungt menneske, som tager denne medicin, der læser indlægssedlen, men som regel vil det være en forælder/plejeperson.
English: Originally reported terms have been coded to preferred terms (using the Medical Dictionary for Regulatory Activities [MedDRA]).
Danish: De oprindeligt indberettede betegnelser er blevet kodet til foretrukne betegnelser (ved hjælp af Medical Dictionary for Regulatory Activities [MedDRA]).
English: No direct effects on electrocardiogram parameters or on the respiratory system were observed.
Danish: Der blev ikke observeret direkte virkninger på elektrokardiogramparametre eller på åndedrætssystemet.
English: Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4
Danish: Grad 3 (følelsesforandringer i mere end 2 uger, objektiv motorisk svækkelse) eller grad 4
English: Polysorbate 20 (E 432)
Danish: Polysorbat 20 (E 432)
English: This is because it is not known if the medicine can pass into breast-milk.
Danish: Det skyldes, at man ikke ved, om lægemidlet kan passere over i modermælken.
English: You might notice the following when you first receive Unituxin and during the course of treatment:
Danish: Du vil måske bemærke følgende første gang, du får Unituxin, og i løbet af behandlingen:
English: High-risk neuroblastomas are more likely to come back again after treatment.
Danish: Neuroblastomer med høj risiko har en større sandsynlighed for at komme tilbage igen efter behandling.
English: Blood culture positive
Danish: Positiv bloddyrkning
English: There was no apparent correlation between the development of these antibodies and allergic reactions.
Danish: Der var ingen åbenbar korrelation mellem udvikling af disse antistoffer og allergiske reaktioner.
English: Your doctor will work out your dose based on your body surface area.
Danish: Din læge beregner din dosis ud fra din krops overfladeareal.
English: You will be closely monitored for these signs while being given the medicine.
Danish: Du vil blive overvåget omhyggeligt for disse tegn, mens du får medicinen.
English: In addition to the above criteria, clinician judgement must be exercised in the evaluation of the patient's cardiovascular functions.
Danish: Foruden ovenstående kriterier skal der anvendes lægelig dømmekraft ved evaluering af patientens kardiovaskulære funktioner.
English: You will be given an anti-histamine medicine which helps to prevent allergic reactions.
Danish: Du vil få et lægemiddel med antihistamin, som er med til at forebygge allergiske reaktioner.
English: Dilution must be carried out under aseptic conditions.
Danish: Fortyndingen skal foretages under aseptiske forhold.
English: Unituxin will be given to you by a doctor or nurse while you are in hospital.
Danish: Du får Unituxin af en læge eller sygeplejerske, mens du ligger på hospitalet.
English: Pregnancy There are no data from the use of dinutuximab in pregnant women.
Danish: Graviditet Der er ingen data fra anvendelse af dinutuximab til gravide kvinder.
English: From a microbiological point of view, the product should be used immediately.
Danish: Af mikrobiologiske hensyn skal produktet anvendes straks.
English: The complete dosing regimen is outlined in Table 1 and Table 2.
Danish: Det komplette behandlingsregime er beskrevet i Tabel 1 og Tabel 2.
English: • You will only be given isotretinoin to take by mouth.
Danish: • Du får kun isotretinoin, som skal tages gennem munden.
English: The clinical study report should be submitted by
Danish: Den kliniske studierapport skal indsendes inden
English: Non-clinical data reveal no special hazard for humans based on conventional studies conducted to date.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier, der er udført til dato.
English: Serious anaphylactic/allergic reactions were reported in 14% of patients.
Danish: Der blev rapporteret alvorlige anafylaktiske/allergiske reaktioner hos 14 % af patienterne.
English: The infusion must be terminated after 20 hours, even if the full dose cannot be delivered within this timeframe.
Danish: Infusionen skal afbrydes efter 20 timer, også selvom den fulde dosis ikke kan indgives inden for dette tidsrum.
English: It should be administered by intravenous infusion over 10 hours.
Danish: Det skal administreres ved intravenøs infusion over 10 timer.
English: Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Danish: Din læge vil tage blodprøver og måske teste dine øjne, mens du får medicinen.
English: Day IL-21
Danish: Dag IL-21
English: You will not be given all of the medicines in every course.
Danish: Du får ikke alle lægemidlerne i alle behandlingsforløbene.
English: It belongs to a group of medicines called ‘monoclonal antibodies'.
Danish: Dette stof tilhører en gruppe lægemidler, der kaldes ‘monoklonale antistoffer'.
English: How much is given
Danish: Så meget vil du få
English: It is given as a drip into one of your veins (intravenous infusion).
Danish: Du får det som drop i en af dine vener (intravenøs infusion).
English: • Resume infusion at the original rate.
Danish: • Genoptag infusionen ved den oprindelige hastighed.
English: It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
Danish: Det skal administreres af sundhedspersonale, der er parat til at håndtere alvorlige allergiske reaktioner, inklusive anafylaksi, i et miljø, hvor der er umiddelbar adgang til fuldt genoplivningsudstyr.
English: Classical biotransformation studies have not been performed.
Danish: Der er ikke udført klassiske biotransformationsstudier.
English: If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
Danish: Hvis morfin ikke tolereres, kan der anvendes fentanyl eller hydromorfon.
English: These work like the antibodies produced naturally by the body.
Danish: De virker ligesom de antistoffer, der dannes naturligt i kroppen.
English: Systemic infections
Danish: Systemiske infektioner
English: You will be given pain relieving medicines (such as paracetamol, ibuprofen and morphine) to help prevent and reduce the pain.
Danish: Du vil få smertestillende medicin (f.eks. paracetamol, ibuprofen og morfin), som skal være med til at forebygge og lindre smerten.
English: - ‘intravenous immunoglobulin' - you should not have this type of medicine in the two weeks before
Danish: - ‘intravenøs immunglobulin' - du må ikke få denne type medicin de sidste to uger før behandlingen med
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER United Therapeutics Europe, Ltd.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN United Therapeutics Europe, Ltd.
English: Central nervous system (CNS) toxicity
Danish: Centralnervesystem (CNS)-toksicitet
English: When Unituxin attaches to the GD2 on the cancer cells, the patient's immune system starts to attack these cells and kill them.
Danish: Når Unituxin sætter sig på GD2 på kræftcellerne, begynder patientens immunforsvar at angribe og dræbe disse celler.
English: Plasma concentrations of dinutuximab, especially trough levels, tended to be lower in patients with HACA.
Danish: Plasmakoncentrationer af dinutuximab, særlig dalniveauer, havde tendens til at være lavere hos patienter med HACA.
English: Tests and checks
Danish: Prøver og kontrol
English: Tell your doctor or nurse straight away if you notice the following:
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du bemærker følgende:
English: Unituxin is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies.
Danish: Unituxin er begrænset til udelukkende hospitalsbrug og skal administreres under overvågning af en læge med erfaring i brug af onkologiske behandlinger.
English: Therefore caution should be taken when both medicinal products are combined (see section 4.4).
Danish: Der skal derfor udvises forsigtighed, når de to lægemidler kombineres (se pkt.
English: Unituxin treatment and for at least one week after treatment has finished.
Danish: Unituxin eller i mindst en uge efter, at behandlingen er slut.
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke lægemidlet, hvis du bemærker partikler eller misfarvning før administration.
English: To reduce the risk of side effects, your doctor may increase the time allowed for the Unituxin infusion up to 20 hours.
Danish: For at nedsætte risikoen for bivirkninger vil din læge måske sætte den tid, der er sat af til infusion af Unituxin, op til højst 20 timer.
English: BATCH NUMBER
Danish: inden BATCHNUMMER
English: Severe pain (Grade 3 or 4) occurs most frequently during the first 4-day course of dinutuximab, often subsiding over time with subsequent courses.
Danish: Svære smerter (grad 3 eller 4) forekommer som oftest under det første 4-dages behandlingsforløb med dinutuximab og aftager ofte med tiden under de efterfølgende behandlingsforløb.
English: The recommended interval time between treatment discontinuation and breastfeeding is 6 months.
Danish: Det anbefalede tidsinterval mellem seponering af behandlingen og amning er 6 måneder.