FrancophonIA/ELRC3.0 huggingface dataset:
English: Although side effects were common, they appeared to be within acceptable limits.
Danish: Der forekommer hyppige bivirkninger, men de vurderes at være acceptable.
English: As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease.
Danish: Da undersøgelser har vist, at den opnåede beskyttelse falder over tid, bør det overvejes at give en boosterdosis til personer, der vurderes at være i fortsat risiko for invasiv meningokoksygdom.
English: In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants.
Danish: I den anden undersøgelse blev der produceret tilstrækkelige mængder antistoffer hos 79-90 % af deltagerne, og beskyttende niveauer af antistoffer mod alle 4 stammer sås hos 85 %.
English: Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Danish: Trumenba er en vaccine, der anvendes til at beskytte personer fra 10 års-alderen mod invasiv meningokoksygdom forårsaget af en gruppe bakterier, der kaldes Neisseria meningitidis gruppe B.
English: For practical information about using Trumenba, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Trumenba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
Danish: I den første undersøgelse blev der produceret antistoffer i mængder, der var tilstrækkelige til at beskytte mod de 4 hovedstammer, hos 80-90 % af deltagerne, alt efter hvilken stamme der var tale om; 84 % af de vaccinerede deltagere havde beskyttende antistoffer mod alle 4 stammer, da de blev testet.
English: Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria.
Danish: Trumenba indeholder to komponenter, nemlig proteiner, der findes på overfladen af Neisseria meningitidis gruppe B-bakterier.
English: What benefits of Trumenba have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Trumenba?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trumenba have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Trumenba.
English: How is Trumenba used?
Danish: Hvordan anvendes Trumenba?
English: How does Trumenba work?
Danish: Hvordan virker Trumenba?
English: The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
Danish: Ingen af deltagerne var tidligere blevet vaccineret mod N. meningitidis gruppe B. Deltagerne fik 3 doser af vaccinen, og der blev målt antistofrespons mod 4 af bakteriens hovedstammer (dem, der normalt forårsager sygdom i Europa) 1 måned efter den sidste injektion.
English: The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Danish: De tilgængelige data viser, at Trumenba, i form af en 2- eller 3-dosisbehandling, giver bred beskyttelse mod stammerne af Neisseria meningitidis gruppe B, som i øjeblikket findes i Europa.
English: This may take up to 60 minutes.
Danish: Dette kan tage op til 60 minutter.
English: These reactions usually go away within a few days.
Danish: Disse reaktioner går normalt væk inden for nogle få dage.
English: If this happens, you should wait until the reactions have disappeared.
Danish: Hvis dette sker, bør du vente, til reaktionerne er forsvundet.
English: Wash your hands thoroughly.
Danish: Vask hænder: Vask dine hænder grundigt.
English: Allow to dry (at least 30 seconds).
Danish: Lad det tørre (i mindst 30 sekunder).
English: Prepare a clean work area.
Danish: Klargør en ren arbejdsflade.
English: It is very important to infuse the medicine at the correct speed.
Danish: Det er meget vigtigt at infundere lægemidlet med den rigtige hastighed.
English: (purity of at least 98% IgG)
Danish: (renhed på mindst 98 % IgG)
English: Potential complications can often be avoided by:
Danish: Mulige komplikationer kan ofte undgås ved at sikre, at:
English: Participation in the registry is voluntary.
Danish: Registreringen er frivillig.
English: All other patients should be observed for at least 20 minutes after the administration.
Danish: Alle andre patienter bør observeres i mindst 20 minutter efter administrationen.
English: Consequences of an overdose are not known.
Danish: Følgerne af en overdosis er ikke kendte.
English: Direct Coombs' test positive
Danish: Positiv direkte Coombs' test
English: Tmax [days]
Danish: Tmax [dage]
English: Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Danish: Dato for første markedsføringstilladelse: 16. maj 2013 Dato for fornyelse: 8. januar 2018
English: The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product.
Danish: Formålet med dette register er at indsamle og dele data alene med de offentlige sundhedsmyndigheder, der er ansvarlige for overvågning af sikkerheden ved dette produkt.
English: Signs or symptoms of these rare allergic reactions include:
Danish: Tegn og symptomer på disse sjældne allergiske reaktioner omfatter:
English: This may occur if you have IgA deficiency.
Danish: Dette kan forekomme, hvis du har IgA-mangel.
English: True hypersensitivity reactions are rare.
Danish: Egentlige overfølsomhedsreaktioner er sjældne.
English: The safety of IG 10% has been demonstrated in several non-clinical studies.
Danish: Sikkerheden af IG 10% er blevet påvist i flere ikke-kliniske studier.
English: National unique code included.
Danish: Der er anført en national unik kode.
English: Detailed Instructions for Use are provided in the section below.
Danish: En detaljeret brugsanvisning findes i afsnittet nedenfor.
English: Hypertension, blood pressure increase
Danish: Hypertension, stigning i blodtryk
English: Thrombosis may also occur in the absence of known risk factors.
Danish: Trombose kan også forekomme, uden at kendte risikofaktorer er til stede.
English: Protein (grams)
Danish: Protein (gram)
English: Sometimes your doctor may recommend that larger doses are split and given at two sites at once.
Danish: Af og til vil din læge muligvis anbefale, at større doser deles op og indgives to steder på en gang.
English: In the case of measles, this impairment may persist for up to 1 year.
Danish: I tilfælde af mæslinger kan denne påvirkning vare i op til 1 år.
English: • Expiration date: Do not use beyond expiration date.
Danish: • Udløbsdato: Brug ikke præparatet efter udløbsdatoen.
English: Local reactions (total):
Danish: Lokale reaktioner (i alt):
English: This medicinal product does not contain sugars.
Danish: Dette lægemiddelindeholder ikke sukkerarter.
English: The following dosage regimens are given as a guideline.
Danish: Nedenstående doseringer er angivet som en retningslinje.
English: Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79)
Danish: Angivelig clearance eller clearance [ml/kg pr. dag] 1,6 (1,4 til 1,79)
English: The recommended infusion rate given in section 4.2 should be adhered to.
Danish: Den anbefalede infusionshastighed, der er anført i punkt 4.2, bør overholdes.
English: The following warnings and precautions should be taken into consideration before you receive or use HyQvia.
Danish: Følgende advarsler og forsigtighedsregler skal tages i betragtning, inden du får eller bruger HyQvia.
English: 10 minutes
Danish: 10 minutter
English: Prepare the pump: Follow the manufacturer's instructions for preparing the pump.
Danish: Gør pumpen klar: Følg producentens anvisninger til klargøring af pumpen.
English: Push the air into the vial.
Danish: Skub luften ind i hætteglasset.
English: AUC per week [g*days/l]
Danish: AUC pr. uge [g*dage/l]
English: - there has been a long interval (e.g., more than 2 or 3 infusion intervals) since you last received
Danish: - der er gået en lang periode (f.eks. mere end 2 eller 3 infusionsintervaller), siden du sidst fik
English: • Depending on the severity of associated reaction, and medical practice, pre-medication may prevent this type of reaction.
Danish: • Afhængigt af sværhedsgraden af den medfølgende reaktion og den medicinske praksis kan præmedicinering forebygge denne type reaktion.
English: To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l).
Danish: For at nedsætte infektionsraten kan det være nødvendigt at øge doseringen og sigte efter højere dalniveauer (> 6 g/l).
English: Antibodies are part of the immune system (the body's natural defences) and help your body to fight infections.
Danish: Antistofferne er en del af immunsystemet (kroppens naturlige forsvar) og hjælper din krop med at bekæmpe infektioner.
English: It is usually prepared from pooled human plasma from not fewer than 1,000 donations.
Danish: Det fremstilles sædvanligvis af humant plasma poolet af mindst 1.000 donationer.
English: Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days.
Danish: I modsætning til de stabile strukturkomponenter i den interstitielle matrix har hyaluronan en meget hurtig omsætning med en halveringstid på ca. 0,5 dag.
English: The majority of these ARs were mild to moderate.
Danish: Størstedelen af disse bivirkninger var lette til moderate.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Danish: IgG og IgG-komplekser nedbrydes i det retikuloendoteliale systems celler.
English: • This medicinal product is comprised of two vials.
Danish: • Dette lægemiddel består af to hætteglas.
English: Infusions of medicines like HyQvia can occasionally result in serious, but rare, allergic reactions.
Danish: Infusion med medicin som HyQvia kan af og til medføre alvorlige, men sjældne, allergiske reaktioner.
English: Side effects seen with similar medicines
Danish: Bivirkninger, der ses med tilsvarende medicin
English: Like all medicines, this medicine can have side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However, needles with smaller diameters may be used if slower flow rates are acceptable.
Danish: Kanyler med en mindre diameter kan dog bruges, hvis en langsommere indgivelseshastighed er acceptabel.
English: - into a blood vessel (intravenously).
Danish: - i en blodåre (intravenøst).
English: Terminal half life [days]
Danish: Terminal halveringstid [dage]
English: The dosage interval to maintain steady state levels varies from 2-4 weeks.
Danish: Doseringsintervallet til opretholdelse af steady state-niveauer varierer fra 2 til 4 uger.
English: It is unknown whether these antibodies may have any clinical significance in humans.
Danish: Det vides ikke, om disse antistoffer kan have klinisk signifikans hos mennesker.
English: Produced from the plasma of human donors.
Danish: Fremstillet af humant plasma fra donorer.
English: • Repeat this step if you have a second infusion site.
Danish: • Gentag dette trin, hvis du har to infusionssteder.
English: In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response.
Danish: Ved substitutionsbehandling skal dosis muligvis være individuel for hver patient afhængigt af den farmakokinetiske og kliniske respons.
English: Slowly and carefully push the plunger to remove any remaining air.
Danish: Tryk langsomt og forsigtigt stemplet ind for at fjerne eventuel resterende luft.
English: The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.
Danish: Virkningerne af hyaluronidase er reversible, og permeabiliteten i det subkutane væv genoprettes inden for 24 til 48 timer.
English: Patients should be sufficiently hydrated before use of immunoglobulins.
Danish: Patienterne skal være tilstrækkeligt hydrerede inden anvendelse af immunglobuliner.
English: Higher incidences of AMS were seen in women.
Danish: Der sås højere hyppigheder af AMS hos kvinder.
English: The listed interactions apply both to adults and children.
Danish: De anførte interaktioner gælder for både voksne og børn.
English: 3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL.
Danish: 3, hovedsageligt fra den granulocytiske serie, og et forhøjet proteinniveau på op til flere hundrede mg/dl.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Doctors are aware of these possible side effects and will monitor you during and after the initial infusions.
Danish: Lægerne er klar over disse mulige bivirkninger og vil overvåge dig under og efter de første infusioner.
English: Interference with serological testing
Danish: Interferens i serologiske test
English: Gather all supplies: Collect all items for your infusion.
Danish: Saml alle tingene: Saml alt det, du skal bruge til infusionen.
English: Frequencies per infusion have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Danish: Hyppigheder pr. infusion er blevet evalueret ud fra følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Consider using longer needles and/or more than one infusion site.
Danish: Overvej at bruge længere kanyler og/eller mere end et infusionssted.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm
Danish: Undersøgelser af cerebrospinalvæske er ofte positive for pleocytose med op til flere tusinde celler pr. mm
English: • Pull the needle wings straight up and out.
Danish: • Træk kanylens vinger lige op og ud.
English: Seventy eight (78) of 83 (94%) subjects attained the same 3- or 4-week dosing whereas one decreased from 4 to 3 weeks, one from 4 to 2 weeks and one from 3 to 2 weeks (2 subjects withdrew during the titration period).
Danish: Otteoghalvfjerds (78) af 83 (94 %) personer opnåede samme 3 eller 4 ugers dosering, mens én gik ned fra 4 til 3 uger, én fra 4 til 2 uger og én fra 3 til 2 uger (2 personer trak sig ud under titreringsperioden).
English: HyQvia contains many different antibodies, some of which can affect blood tests (serological tests).
Danish: HyQvia indeholder mange forskellige antistoffer, hvoraf nogle kan påvirke blodprøver (serologiske prøver).
English: Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers.
Danish: Tag et fast greb i huden og fold mindst 2 til 2,5 cm hud mellem to fingre.
English: Non-clinical data reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet.
English: Certain side effects may occur more frequently if: - you are receiving HyQvia for the first time.
Danish: Visse bivirkninger kan forekomme hyppigere, hvis: - du får HyQvia for første gang.
English: Burning sensation
Danish: Brændende fornemmelse
English: You and your guardian will be trained to detect early signs of side effects, especially allergic reactions.
Danish: Du og din hjælper vil blive oplært i at opdage tidlige tegn på bivirkninger, især allergiske reaktioner.
English: Use aseptic technique when preparing and administering HyQvia.
Danish: Brug aseptisk teknik ved forberedelse og administration af HyQvia.
English: After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Danish: Efter administration af dette lægemiddel bør der være et interval på 3 måneder før vaccination med levende svækkede virusvacciner.
English: Local reactions (total)
Danish: Lokale reaktioner (i alt)
English: From post-marketing data no clear correlation of AMS to higher doses was observed.
Danish: Fra data efter markedsføringen blev der ikke observeret nogen tydelig forbindelse mellem AMS og højere doser.
English: Distribution of the IgG subclasses (approx. values): IgG1  56.9%
Danish: Fordeling af IgG-subklasser (omtrentlige værdier): IgG1 ≥ 56,9 %
English: If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry.
Danish: Hvis en kvinde bliver gravid, skal den behandlende læge opfordre hende til at indgå i graviditetsregistret.
English: In the beginning you will receive one quarter of this dose at 1 week intervals.
Danish: I starten vil du få det kvarte af denne dosis med 1 uges mellemrum.
English: The rHuPH20 may be hand-pushed or infused by a pump.
Danish: Komponenten rHuPH20 kan skubbes med hånden eller infunderes med en pumpe.
English: Your doctor may also adjust your dose depending on your response to treatment.
Danish: Din læge kan også justere din dosis ud fra, hvordan du reagerer på behandlingen.
English: Replacement therapy in adults, children and adolescents (0-18 years) in:
Danish: Substitutionsbehandling hos voksne, børn og unge (0-18 år) ved:
English: o Select sites on the opposite sides of the body if instructed to infuse in two sites for doses above 600 ml.
Danish: o Vælg steder på hver sin side af kroppen, hvis du er blevet instrueret i at give infusionen på to steder med doser over 600 ml.
English: If you think that you used more HyQvia than you should, speak to your doctor as soon as possible.
Danish: Hvis du tror, at du har brugt mere HyQvia end du skulle, skal du tale med din læge hurtigst muligt.
English: Volume (ml)
Danish: Indhold (ml)
English: Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose.
Danish: Hyppigheden og antallet af infusionssteder tilpasses under hensyntagen til mængde, samlet infusionstid og tolerabilitet, således at patienten får den samme ugentlige dosis.
English: Solutions that are cloudy or have deposits should not be used.
Danish: Opløsninger, der er uklare eller har udfældninger, må ikke anvendes.
English: The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin.
Danish: Den første infusion med HyQvia gives en uge efter den sidste behandling med det tidligere immunglobulin.
English: If two sites are used, the two infusion sites should be on contra lateral sides of the body.
Danish: Hvis der bruges to infusionssteder, bør disse være på hver sin laterale side af kroppen.
English: • Tell your doctor or nurse immediately if you notice any of these signs during the infusion.
Danish: • Fortæl det straks til lægen eller sundhedspersonalet, hvis du bemærker nogen af disse tegn under infusionen.
English: Effects on blood tests
Danish: Påvirkning af blodprøver
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HyQvia in one or more subsets of the paediatric population in treatment of primary immunodeficiency as model for replacement therapy.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med HyQvia i en eller flere undergrupper af den pædiatriske population til behandling af primær immundefekt som model for substitutionsbehandling.
English: They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Danish: De kan især opstå hos patienter med anti-IgA-antistoffer, som skal behandles med særlig forsigtighed.
English: Therefore, patients receiving measles vaccine should have their antibody status checked.
Danish: Derfor bør patienter, der modtager mæslingevaccine, have kontrolleret deres antistofstatus.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in the blood.
Danish: Medicinen virker på nøjagtigt samme måde som det immunglobulin, der findes naturligt i blodet.
English: Secure the needle to the skin:
Danish: Fastgør kanylen til huden:
English: A-1221 Vienna
Danish: A-1221 Wien
English: Spread of localised infections
Danish: Spredning af lokale infektioner
English: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned condition.
Danish: Doseringen til børn og unge (0-18 år) adskiller sig ikke fra doseringen til voksne, da doseringen til hver enkelt indikation beregnes efter kropsvægt og justeres efter den kliniske konsekvens af ovennævnte tilstand.
English: If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
Danish: Hvis en patient glemmer en dosis, indgives den glemte dosis snarest muligt, og derefter genoptages den gældende planlagte behandling.
English: Trough levels should be measured and assessed in conjunction with the incidence of infection.
Danish: Dalniveauerne bør måles og vurderes i forbindelse med forekomsten af infektion.
English: HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety).
Danish: HyQvia blev evalueret hos 24 pædiatriske patienter, herunder 13 patienter mellem 4 og < 12 år og 11 mellem 12 og < 18 år, som blev behandlet i op til 3,3 år med en samlet sikkerhedserfaring svarende til 48,66 patientår (som beskrevet i afsnittet Klinisk virkning og sikkerhed).
English: There are currently no clinical safety data for HyQvia on fertility available.
Danish: Der er på nuværende tidspunkt ingen kliniske sikkerhedsdata for HyQvia for så vidt angår fertilitet.
English: • Please also see section 2 of this leaflet about the risk of allergic reactions and using HyQvia at home.
Danish: • Se også punkt 2 i denne indlægsseddel vedrørende risiko for allergiske reaktioner og brug af