FrancophonIA/ELRC3.0 huggingface dataset:
English: When using multiple vials to achieve the desired dose, repeat this step.
Danish: Hvis du skal bruge flere hætteglas for at opnå den ønskede dosis, gentages dette trin.
English: Individualize the duration of any treatment beyond 18months based upon the patient's response and demonstrated need for continued therapy.
Danish: Varigheden af enhver behandling ud over 18 måneder skal tilpasses individuelt baseret på patientens respons og påviste behov for fortsat behandling.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in your blood.
Danish: Medicinen virker på nøjagtigt samme måde som de immunglobuliner, der er naturligt til stede i blodet.
English: Therefore patients receiving measles vaccine should have their antibody status checked.
Danish: Derfor bør patienter, der får vaccine mod mæslinger, få deres antistofstatus kontrolleret.
English: You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Danish: Du kan være allergisk (overfølsom) over for immunglobuliner uden at være klar over det.
English: The medicine is used in adults and children (0-18 years) in the following situations:
Danish: Medicinen anvendes til voksne og børn (0-18 år) i følgende situationer:
English: Distribution of the IgG subclasses (approx. values): IgG1 ...........69%
Danish: Fordeling af IgG-subklasser (cirkaværdier): IgG1 ...........69 %
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be switched to Hizentra only under close medical supervision.
Danish: Patienter med anti-IgA-antistoffer, hvor behandling med subkutane IgG-produkter forbliver den eneste mulighed, bør kun skiftes til Hizentra under nøje lægetilsyn.
English: An infusion was considered valid, if ≥95 % of the planned flow rate/volume per ≥1 infusion site was achieved.
Danish: En infusion blev vurderet at være valid, hvis ≥ 95 % af den planlagte flowhastighed/volumen pr. ≥ 1 infusionssted blev nået.
English: In infants and children, infusion site may be changed every 5-15 ml.
Danish: Hos spædbørn og børn kan der skiftes infusionssted for hver 5-15 ml.
English: Infusion parameter and responder rate (%)
Danish: Infusionsparameter og responsrate (%)
English: Patients should be closely monitored and carefully observed for any adverse events throughout the infusion period.
Danish: Patienterne skal monitoreres nøje og observeres omhyggeligt for eventuelle utilsigtede hændelser gennem hele infusionsperioden.
English: After receiving Hizentra, the results of certain blood tests (serological tests) may be impaired for a certain time.
Danish: Efter indgivelse af Hizentra kan resultaterne af visse blodprøver (serologiske test) være påvirket i en vis periode.
English: In all three groups, each infusion parameter was used for 4 weeks, after which subjects successfully completing required minimal number of valid infusions could switch to the next higher infusion parameter.
Danish: I alle tre grupper blev hver infusionsparameter anvendt i 4 uger, hvorefter de forsøgsdeltagere, som havde gennemført det påkrævede minimale antal valide infusioner, kunne skifte til den næste højere infusionsparameter.
English: •the testing of each donation and pools of plasma for signs of virus/infections.
Danish: •testning af alle plasmadonationer og -pools for tegn på vira/infektioner.
English: You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you use Hizentra”).
Danish: Du må ikke tage det, hvis du lider af hyperprolinæmi (se også afsnit 2 ”Det skal du vide, før du begynder at bruge Hizentra”).
English: Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Danish: Afhængigt af det kliniske respons (f.eks. infektionshyppighed) kan der overvejes justering af dosis og/eller behandlingsintervallet for at tilstræbe højere dalniveauer.
English: Hizentra contains residual amounts of IgA which might cause an allergic reaction.
Danish: Hizentra indeholder restmængder af IgA, hvilket kan forvolde en allergisk reaktion.
English: Patient`s individual clinical response should be the primary consideration in dose adjustment.
Danish: Patientens individuelle kliniske respons bør være den afgørende faktor ved dosisjusteringer.
English: Grasp the skin between 2 fingers and insert the needle into the subcutaneous tissue.
Danish: Tag fat om huden med 2 fingre, og indfør nålen i det subkutane væv.
English: Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen, da den indeholder vigtige oplysninger.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Danish: Det har en fordeling af immunglobulin G-subklasser, der er tilnærmelsesvist proportional med fordelingen i det oprindelige humane plasma.
English: Your healthcare professional will avoid potential complications by ensuring: ►that you are not sensitive to human normal immunoglobulin.
Danish: Sundhedspersonalet vil undgå potentielle komplikationer ved at sikre, at: ►du ikke er overfølsom over for humant normalt immunglobulin.
English: Posology Adults and children (0-18 years)
Danish: Voksne og børn (0-18 år)
English: Other important information about Hizentra
Danish: Anden vigtig information om Hizentra
English: They help your body to fight infections caused by bacteria and viruses or maintain the balance in your immune system (referred to as immunomodulation).
Danish: De hjælper din krop med at bekæmpe infektioner forårsaget af bakterier og virus og opretholder balancen i dit immunsystem (kaldet immunmodulation).
English: You may use an unlimited number of sites simultaneously.
Danish: Du kan bruge et ubegrænset antal steder på samme tid.
English: In adults doses may be given up to 50 ml/site.
Danish: Hos voksne kan der gives doser på op til 50 ml/sted.
English: • lack of certain immunoglobulin G subclasses causing recurrent infections.
Danish: • mangel på visse immunglobulin G-subklasser, hvilket giver tilbagevendende infektioner.
English: • aseptic infusion techniques
Danish: • aseptiske infusionsteknikker
English: Embolic and thrombotic events
Danish: Emboliske og trombotiske hændelser
English: Do not use solutions that are cloudy or contain particles.
Danish: Brug ikke opløsningen, hvis den er uklar eller indeholder partikler.
English: The syndrome usually begins within several hours to 2 days following immune globulin treatment.
Danish: Syndromet begynder normalt inden for nogle timer til 2 dage efter behandlingen med immunglobulin.
English: As the dose is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dose in the elderly population is not considered to be different from that in subjects 18 to 65 years of age.
Danish: Da dosis angives ud fra legemsvægt og justeres i forhold det kliniske udfald af ovennævnte lidelser, anses dosis i den ældre population ikke som forskellig fra dosis hos forsøgspersoner mellem 18 og 65 år.
English: The initial subcutaneous dose may be a 1:1 conversion from the previous IVIG dose (calculated as weekly dose).
Danish: Den første subkutane dosis kan være en 1:1-omregning af den tidligere IVIg-dosis (beregnet som ugentlig dosis).
English: Information on what Hizentra is made of
Danish: Information om hvad Hizentra er fremstillet af
English: By replacing the missed doses when daily dosing was resumed, the median concentration profile recovered within 2 to 3 days.
Danish: Ved erstatning af de oversprungne doser, når den daglige dosering blev genoptaget, genoprettedes den mediane koncentrationsprofil inden for 2 til 3 dage.
English: However, if missed doses were not replaced when dosing was resumed, it took up to 5-6 weeks for the IgG trough levels to return to steady-state.
Danish: Hvis de oversprungne doser imidlertid ikke blev erstattet, når doseringen blev genoptaget, tog det op til 5-6 uger, før IgG-trough-niveauerne vendte tilbage til steady state.
English: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Danish: Mistanke om allergiske eller anafylaktiske reaktioner kræver øjeblikkeligt injektionsophør.
English: It is believed that the body's defense attack underlines such inflammation, and the immunoglobulins present in Hizentra help to protect the nerves from being attacked (immunomodulatory therapy).
Danish: Det menes, at kroppens forsvarsangreb understreger en sådan betændelsestilstand, og immunglobulinerne i Hizentra hjælper med til at beskytte nerverne mod angreb (immunmodulerende terapi).
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra undersøgelser af sikkerhedsfarmakologi og toksicitet.
English: The medicinal product should be brought to room or body temperature before use.
Danish: Lægemidlet skal bringes til stue- eller legemstemperatur inden brug.
English: You may reduce possible side effects if you infuse Hizentra slowly.
Danish: Du kan reducere mulige bivirkninger ved at infundere Hizentra langsomt.
English: After infusion of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Danish: Efter infusion af immunglobulin kan den forbigående stigning i de forskellige passivt overførte antistoffer i patientens blod resultere i vildledende positive resultater ved serologisk testning.
English: The therapy with Hizentra is initiated 1 week after the last IVIg infusion.
Danish: Behandlingen med Hizentra indledes 1 uge efter den sidste IVIg-infusion.
English: Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Danish: Immunglobuliner er også kendt som antistoffer og er blodproteiner, som hjælper kroppen med at bekæmpe infektioner.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for eventuelle ukendte eller nyopståede vira eller andre infektionstyper.
English: However, medicines that contain immunoglobulins have been used in pregnant or breast-feeding women for years, and no harmful effects on the course of pregnancy or on the baby have been observed.
Danish: Medicin, der indeholder immunglobuliner, er imidlertid blevet brugt til gravide og ammende kvinder i årevis, og der er ikke observeret nogen skadelige virkninger på graviditetens forløb eller på babyen.
English: more than one infusion device can be used simultaneously.
Danish: Der kan anvendes mere end én infusionsanordning samtidig.
English: Hizentra contains proline
Danish: Hizentra indeholder prolin
English: The dose or dosing interval should not be changed without consulting your doctor.
Danish: Lad være med at ændre doseringen eller doseringsintervallet uden at have rådført dig med din læge.
English: If you think you have missed a dose, speak to your doctor as soon as possible.
Danish: Hvis du tror, at du har glemt en dosis, så tal med din læge så snart som muligt.
English: Infusion devices appropriate for subcutaneous administration of immunoglobulins can be used.
Danish: Der kan anvendes infusionsudstyr, der er velegnet til subkutan administration af immunglobuliner.
English: Subjects received in total 1,831 weekly Hizentra infusions.
Danish: Forsøgspersonerne fik i alt 1.831 ugentlige Hizentra-infusioner.
English: phase III study (n = 115), and 1 extension study (n = 82) in patients with CIDP (total N = 502 patients; 26,646 infusions).
Danish: (n = 115) og 1 forlængelsesstudie (n = 82) med patienter med CIPD (i alt n = 502 patienter; 26.646 infusioner).
English: Your doctor will decide whether you can receive Hizentra during your pregnancy or while you are breast-feeding.
Danish: Lægen vil tage stilling til, om du kan få Hizentra under din graviditet, eller mens du ammer.
English: Information on safety with respect to transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Oplysninger om sikkerhed med hensyn til overførbare stoffer Standardforholdsregler til forebyggelse af infektioner, der skyldes brug af lægemidler, der er fremstillet af humant blod eller plasma, omfatter udvælgelse af donorer, screening af enkeltdonationer og plasmapools for specifikke infektionsmarkører samt inkludering af effektive trin til inaktivering/fjernelse af vira som en del af fremstillingsproceduren.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
Danish: •Omhyggelig udvælgelse af blod-og plasmadonorer for at sikre, at personer, der er i risikogruppe som bærer af infektioner, udelukkes, og
English: In case of clinical deterioration the dose may be increased to the recommended maximum of 0.4g/kg weekly dose.
Danish: I tilfælde af klinisk forværring kan dosen øges til den anbefalede maksimale ugentlige dosis på 0,4 g/kg.
English: • there has been a long interval (more than eight weeks) since the previous infusion.
Danish: • der har været en lang pause siden den foregående infusion.
English: Warnings and precautions Talk to your doctor or healthcare professional before using Hizentra.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger Hizentra.
English: CIDP is characterised by chronic inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms.
Danish: CIDP er kendetegnet ved en kronisk betændelsestilstand i de perifere nerver, der forårsager muskelsvaghed og/eller følelsesløshed i ben og arme.
English: Both Hizentra doses demonstrated superiority over placebo for the primary endpoint.
Danish: Begge Hizentra-doser var bedre end placebo, hvad angik det primære endepunkt.
English: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age.
Danish: Doseringen bør føre til et IgG-dalniveau (målt inden den næste infusion) på mindst 5 til 6 g/l og tilstræbes at være inden for referenceintervallet for serum-IgG for aldersgruppen.
English: Please tell your doctor prior to treatment.
Danish: Fortæl det til lægen forud for behandling.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Danish: Når lægemidler fremstilles af humant blod eller plasma, træffes visse forholdsregler for at forhindre, at der overføres infektioner til patienterne.
English: If using an infusion pump, follow the manufacturer's instructions.
Danish: Hvis du anvender en infusionspumpe, skal du følge producentens anvisninger.
English: Tell your doctor or healthcare professional prior to treatment if you have an immunoglobulin type A (IgA) deficiency.
Danish:  Fortæl det til lægen eller sundhedspersonalet forud for behandling, hvis du lider af en immunglobulindefekt type A (IgA).
English: • The volume of product infused into a particular site may vary.
Danish: • Mængden af lægemiddel, der infunderes på et bestemt sted, kan variere.
English: Subjects in both Hizentra dose groups remained stable in electrophysiology parameters.
Danish: Forsøgspersonerne i begge Hizentra-doseringsgrupper lå stabilt i elektrofysiologiparametre.
English: Using smaller needles (i.e. higher gauge number) may make it more difficult to manually push Hizentra.
Danish: Brug af mindre kanyler (dvs. højere gaugetal) kan gøre det sværere at give Hizentra ved manuelt tryk.
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 in replacement therapy indications.
Danish: Doseringen hos børn og unge (0-18 år) er ikke anderledes end hos voksne, da doseringen til hver indikation angives ud fra legemsvægt og justeres i forhold til det kliniske udfald af indikationerne for substitutionsterapi.
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Danish: Der er betryggende klinisk erfaring, der taler for, at hepatitis A og parvovirus B19 ikke overføres med immunglobuliner, og det antages også, at antistofindholdet udgør et vigtigt bidrag til den virale sikkerhed.
English: • an infusion device, or
Danish: • En infusionsanordning eller
English: The safety of Hizentra has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Danish: Sikkerheden ved Hizentra er vurderet i flere prækliniske undersøgelser med særlig reference til hjælpestoffet L-prolin.
English: Please also refer to section 2 “What you need to know before you use Hizentra” for additional details on circumstances which increase the risk of side effect.
Danish: 2 “Det skal du vide, før du begynder at bruge Hizentra” for yderligere oplysninger om forhold, der øger risikoen for bivirkninger.
English: In replacement therapy the dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels.
Danish: Ved substitutionsterapi er individuel dosis muligvis nødvendig afhængigt af den enkelte patients kliniske respons og dalniveauerne for serum-IgG.
English: The primary efficacy endpoint was the percentage of subjects who had a CIDP relapse (defined as a ≥ 1 point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline) or were withdrawn for any other reason in the Hizentra treatment period.
Danish: Det primære effektendepunkt var den procentdel af forsøgspersonerne, der fik CIDP-recidiv (defineret som en stigning ≥ 1 point i justeret INCAT-score [Inflammatory Neuropathy Cause and Treatment] sammenlignet med baseline) eller som blev trukket ud af forsøget af andre grunde i løbet af Hizentrabehandlingsperioden.
English: For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown.
Danish: For spontane bivirkninger efter markedsføringen kategoriseres indberetningshyppigheden som ikke kendt.
English: If using a transfer device (vented spike), follow the instructions provided by the device manufacturer.
Danish: Hvis du anvender et overførselssystem (vented spike), skal du følge producentens anvisninger.
English: Secure the needle to the skin - If necessary, use gauze and tape or transparent dressing to hold the needle in place.
Danish: Fastgør nålen til huden - Om nødvendigt kan der anvendes gaze og tape eller gennemsigtig bandage for at holde nålen på plads.
English: Do NOT infuse Hizentra ► if you are allergic to human immunoglobulins, polysorbate 80 or L-proline.
Danish: Brug IKKE Hizentra: ► hvis du er allergisk over for humane immunglobuliner, polysorbat 80 eller L-prolin.
English: Home-treatment
Danish: Hjemmebehandling
English: Following subcutaneous administration of Hizentra, peak serum levels are achieved after approximately 2 days.
Danish: Efter subkutan indgivelse af Hizentra opnås der maksimale serumniveauer efter cirka 2 dage.
English: If you think you should receive Hizentra more or less frequently, please speak to your doctor.
Danish: Hvis du mener, at du burde have Hizentra hyppigere eller sjældnere, så tal med din læge.
English: Kaplan-Meier Plot Time to CIDP Relapse
Danish: Kaplan-Meier-plot - Tid til CIDP-recidiv
English: Subjects received in total 2,264 weekly Hizentra infusions.
Danish: Forsøgspersonerne fik i alt 2.264 ugentlige Hizentra-infusioner.
English: Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Danish: Seponering af immunglobulin kan resultere i remission af AMS inden for flere dage uden følgevirkninger.
English: In the case of measles, this impairment may persist for up to 1 year.
Danish: For mæslinger kan denne svækkelse vare ved i op til 1 år.
English: Select the infusion site(s) - The number and location of infusion sites depends on the volume of the total dose.
Danish: Vælg infusionsstedet/-stederne - Antallet og placeringen af infusionssteder afhænger af mængden af den totale dosis.
English: ADR frequency category per patient
Danish: Frekvens-kategori pr. patient
English: Immunoglobulins are produced by human body's immune system.
Danish: Immunglobuliner produceres af immunsystemet i menneskets krop.
English: The recommended subcutaneous dose is 0.2 to 0.4 g/kg body weight per week administered in 1 or 2 sessions over 1 or 2 consecutive days.
Danish: Den anbefalede subkutane dosis er 0,2-0,4 g/kg legemsvægt pr. uge, administreret i 1 eller 2 sessioner over 1 eller 2 på hinanden følgende dage.
English: Hizentra belongs to the class of medicines called human normal immunoglobulins.
Danish: Hizentra tilhører den medicinklasse, der kaldes humant normalt immunglobulin.
English: No clinically relevant differences in the serum IgG trough concentrations were observed between the baseline at day 1 and the end of the study in all subjects.
Danish: Der blev ikke set nogen klinisk relevante forskelle i dalkoncentrationen af IgG i serum mellem baseline på dag 1 og studiets afslutning hos nogen af forsøgsdeltagerne.
English: Patients exhibiting signs and symptoms of AMS should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Danish: Patienter, der udviser tegn og symptomer på AMS, skal have foretaget en grundig neurologisk undersøgelse, herunder undersøgelse af cerebrospinalvæsken, for at udelukke andre årsager til meningitis.
English: No clinical studies have been performed with Hizentra in pregnant women.
Danish: Der er ikke foretaget nogen kliniske undersøgelser med Hizentra hos gravide kvinder.
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01.
Danish: Farmakoterapeutisk klassifikation: immunsera og immunglobuliner: immunglobuliner, normale humane, til ekstravaskulær indgivelse, ATC-kode: J06BA01.
English: No serious bacterial infections were reported during the efficacy period in subjects receiving Hizentra during clinical studies.
Danish: Der blev ikke rapporteret alvorlige bakterieinfektioner i løbet af virkningsperioden hos forsøgspersoner, der fik Hizentra i kliniske studier.
English: Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Danish: Immunglobuliner udskilles i human mælk og kan bidrage til overførslen af beskyttende antistoffer til det nyfødte barn.
English: • Pain related to the musculature and bones (musculoskeletal pain)
Danish: • Smerter i muskler og knogler (muskuloskeletale smerter)
English: In a third group, infusion volumes of 25, 40 and 50ml per site were additionally evaluated in pump-assisted administration of weekly Hizentra doses (n=15).
Danish: I en tredje gruppe blev infusionsvoluminer på 25, 40 og 50 ml pr. sted yderligere evalueret ved pumpe-assisteret administration af ugentlige Hizentra-doser (n = 15).
English: In these rare cases allergic reactions, such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
Danish: I disse sjældne tilfælde kan der forekomme allergiske reaktioner som f.eks. pludseligt blodtryksfald eller shock (se også afsnit 4 ”Bivirkninger”).