FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder (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: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: If patients were previously on a 3-week dosing regimen, increasing the interval to 4-weeks can be accomplished by administering the same weekly equivalents.
Danish: Hvis patienterne tidligere blev behandlet efter et 3-ugers doseringsregime, kan et længere interval på 4 uger opnås gennem administration af de samme ugentlige ækvivalenter.
English: The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm.
Danish: Der en potentiel risiko for, at sådanne antistoffer krydsreagerer med endogent PH20, som er kendt for at komme til udtryk i voksne mænds testikler, epididymis og sperma.
English: The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level).
Danish: Tabellen nedenfor er klassificeret efter MedDRA systemorganklasse (SOK og foretrukken term-niveau).
English: Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment.
Danish: Din læge vil beregne den korrekte dosis til dig ud fra din kropsvægt, eventuel tidligere behandling, som du har fået, og hvordan du reagerer på behandlingen.
English: Patients must be closely monitored throughout the infusion period, particularly patients starting with therapy.
Danish: Patienterne skal overvåges omhyggeligt i hele infusionsperioden, især når patienterne begynder på behandlingen.
English: During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
Danish: Under infusionen skal du være opmærksom på de første tegn på bivirkninger (du finder yderligere oplysninger i punkt 4, ”Bivirkninger”).
English: This may have to be considered for patients who are on a controlled sodium diet.
Danish: Der skal muligvis tages højde for dette hos patienter, der er på en natriumkontrolleret diæt.
English: The following infusion rates of the IG 10% are recommended per infusion site:
Danish: Følgende infusionshastigheder anbefales for IG 10 % pr. infusionssted:
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Danish: Dette lægemiddels sikkerhed ved anvendelse under human graviditet er ikke fastlagt i kontrollerede kliniske forsøg, og HyQvia skal derfor gives med forsigtighed til gravide kvinder og ammende mødre.
English: Do not inject or infuse HyQvia
Danish: Du må ikke injicere eller infundere HyQvia
English: Patients were treated with HyQvia at either 3- or 4-week treatment intervals for a total of 12 months (following a brief titration period).
Danish: Patienterne blev behandlet med HyQvia med enten 3 eller 4 ugers behandlingsintervaller i alt i 12 måneder (efter en kort titreringsperiode).
English: If you become pregnant when using HyQvia, you should discuss with your doctor the possibility of participating in a pregnancy registry in order to collect data on your pregnancy and the development of the baby.
Danish: Hvis du bliver gravid, mens du bruger HyQvia, bør du tale med din læge om muligheden for at komme med i et graviditetsregisterfor at indsamle data om din graviditet og barnets udvikling.
English: Do not use heating devices including microwave.
Danish: Brug ikke apparater til opvarmning, herunder mikrobølgeovn.
English: - you have received another immunoglobulin and have been switched to HyQvia.
Danish: - du har fået et andet immunglobulinpræparat og er skiftet til HyQvia.
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of viruses/infections.
Danish: - omhyggelig udvælgelse af blod- og plasmadonorer for at sikre, at dem, der har risiko for at være smittebærere, bliver udelukket, og - test af hver enkelt bloddonation og plasmapulje for tegn på virus/infektioner.
English: The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%.
Danish: Rekombinant humant hyaluronidase faciliterer dispersionen og absorptionen af IG 10 %.
English: Interval/Minutes
Danish: Interval/minutter
English: HyQvia is prescribed as replacement therapy to patients who do not have sufficient antibodies, including the following groups:
Danish: HyQvia ordineres som erstatningsbehandling til patienter, som ikke har tilstrækkelige mængder antistoffer, herunder følgende grupper:
English: It is depolymerized by the naturally occurring enzyme hyaluronidase.
Danish: Det depolymeriseres af det naturligt forekommende enzym hyaluronidase.
English: • Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
Danish: • Skriv dato, tidspunkt, dosis, infusionssted(er) (som en hjælp til at skifte mellem stederne) og eventuelle reaktioner efter hver infusion.
English: In case of shock, immediately discontinue the infusion and treat the patient for shock.
Danish: I tilfælde af chok skal infusionen ophøre straks, og patienten skal behandles for chok.
English: ► Tell your doctor about your treatment with HyQvia before any blood test.
Danish: ► Fortæl din læge om din behandling med HyQvia, inden du får taget blodprøver.
English: This guardian should help you keep an eye on potential side effects.
Danish: Din hjælper skal være med til at holde øje med mulige bivirkninger.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP/Udløbsdato.
English: Nearly all of the subjects were able to attain the same dose interval with HyQvia as they had for intravenous administration.
Danish: Næsten alle forsøgspersonerne var i stand til at opnå samme dosisinterval med HyQvia, som de havde med den intravenøse administration.
English: The most frequently reported adverse reactions (ARs) of HyQvia were local reactions.
Danish: De hyppigst rapporterede bivirkninger ved HyQvia var lokale reaktioner.
English: A 24 gauge needle may be required to allow patients to infuse at flow rates of 300 mL/hr/infusion site.
Danish: Det kan være nødvendigt med en 24 gauge kanyle, for at patienter kan infundere med en indgivelseshastighed på 300 ml/timen/infusionssted.
English: A-1221 Vienna, Austria
Danish: A-1221 Wien, Østrig
English: Since HyQvia contains trace amounts of IgA, you might have an allergic reaction.
Danish: Da HyQvia indeholder spormængder af IgA, kan du muligvis få en allergisk reaktion.
English: 90-degree angle to skin
Danish: 90-graders vinkel i forhold til huden
English: After infusion of immunoglobulins, 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 misvisende positive resultater i serologiske test.
English: ► If you experience a severe side effect, you or your guardian must seek emergency treatment immediately.
Danish: ► Hvis du oplever en alvorlig bivirkning, skal du eller din hjælper straks søge akut behandling.
English: You must carefully follow your doctor's instructions regarding the dose, infusion speed and schedule for infusing HyQvia so that your treatment works for you.
Danish: Du skal følge din læges instruktioner nøje med hensyn til dosis, infusionshastighed og tidsplan for infusionerne med HyQvia, så behandlingen virker på dig.
English: • Official batch release
Danish: • Officiel batchfrigivelse
English: If the patient tolerates the initial infusions at the full dose per site and maximum rate, an increase in the rate of successive infusions may be considered at the discretion of the physician and the patient.
Danish: Hvis patienten tolererer de indledende infusioner ved fuld dosis pr. sted og maksimal hastighed, kan en øgning af hastigheden for de efterfølgende infusioner overvejes efter lægens og patientens vurdering.
English: HyQvia is used in patients with a weak immune system, who do not have enough antibodies in their blood and tend to get frequent infections.
Danish: HyQvia bruges hos patienter med et svagt immunsystem, som ikke har nok antistoffer i blodet og er tilbøjelige til at få hyppige infektioner.
English: Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue.
Danish: Hyaluronan er et polysakkarid, der findes i den intercellulære matrix i bindevævet.
English: You are at increased risk of allergic reactions if you have IgA deficiency with anti-IgA antibodies.
Danish: Du har forhøjet risiko for allergiske reaktioner, hvis du har IgA-mangel med anti-IgA-antistoffer.
English: Do not use this medicine if the solutions are cloudy or have particles or deposits.
Danish: Brug ikke lægemidlet, hvis opløsningerne er uklare eller indeholder partikler eller udfældninger.
English: HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks.
Danish: HyQvia kan anvendes til at indgive en fuld behandlingsdosis på et til to steder op til hver fjerde uge.
English: See sections 4.2 and 4.8.
Danish: 4.2 og 4.8.
English: The listed warnings and precautions apply both to adults and children.
Danish: De anførte advarsler og forsigtighedsregler gælder for både voksne og børn.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt middel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også ukendte eller nyopdagede virus og andre patogener.
English: 66 patients who completed the pivotal phase 3 study participated in an extension study (160902) for the evaluation of long-term safety, tolerability and efficacy of HyQvia in PID.
Danish: 66 patienter, der gennemførte det pivotale fase 3-forsøg, deltog i et udvidet forsøg (160902) til evaluering af langtidssikkerheden, -tolerabiliteten og -virkningen af HyQvia ved PID.
English: You will be watched carefully throughout the infusion and for at least 1 hour after stopping the infusion to see how well you tolerate the medicine.
Danish: Der vil blive holdt omhyggeligt øje med dig under hele infusionen og i mindst 1 time, efter at infusionen er stoppet, for at se, hvor godt du tåler medicinen.
English: Name and address of the manufacturers of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: Your treatment will be started by a doctor or nurse experienced in treating patients with a weak immune system and in guiding patients for home treatment.
Danish: Du vil i starten få behandlingen af en læge eller sygeplejerske, der har erfaring i at behandle patienter med et svagt immunsystem og i at vejlede patienter i hjemmebehandling.
English: - if you have antibodies against immunoglobulin A (IgA) in your blood.
Danish: - Hvis du har antistoffer mod immunglobulin A (IgA) i dit blod.
English: Animal studies do not indicate direct or indirect harmful effects of recombinant human hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3).
Danish: Dyrestudier viser ikke nogen direkte eller indirekte skadelige virkninger af rekombinant humant hyaluronidase med hensyn til reproduktionspotentialet ved de doser, der anvendes til facilitering af administration af IG 10 % (se pkt.
English: In the beginning your doctor or nurse will use a slow infusion speed and gradually increase it during the first infusion and in the following infusions.
Danish: I starten vil din læge eller sygeplejerske bruge en langsom infusionshastighed og øge den gradvist i løbet af den første infusion og ved de efterfølgende infusioner.
English: Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions.
Danish: Resultater af kliniske studier indikerer, at sikkerhedsprofilen for den voksne og for den pædiatriske population, herunder med hensyn til art, hyppighed, sværhedsgrad og reversibilitet af bivirkninger, var ens.
English: If you forget to use HyQvia
Danish: Hvis du har glemt at bruge HyQvia
English: The IG 10% component provides the therapeutic effect of this medicinal product.
Danish: Komponenten IG 10 %, giver den terapeutiske virkning ved dette lægemiddel.
English: The treatment required depends on the nature and severity of the adverse reaction.
Danish: Påkrævet behandling afhænger af arten og sværhedsgraden af bivirkningen.
English: Therefore, after receiving HyQvia, you may have to wait for up to 3 months before receiving certain vaccines.
Danish: Efter at du har fået HyQvia, skal du derfor muligvis vente op til 3 måneder, før du får visse vacciner.
English: Once the doctor or nurse has found the right dose and speed of infusion for you, you may be allowed to give the treatment to yourself at home.
Danish: Når først lægen eller sygeplejersken har fundet den dosis og infusionshastighed, der er den rigtige for dig, vil du måske få lov til at behandle dig selv hjemme.
English: • Avoid bony areas, visible blood vessels, scars and any areas of inflammation or infection.
Danish: • Undgå områder med knogler, synlige blodkar, ar og eventuelle områder med betændelse eller infektion.
English: HyQvia must not be given intravenously or intramuscularly.
Danish: HyQvia må ikke indgives intravenøst eller intramuskulært.
English: • If patient is at high risk for any allergic reactions, the product should be administered only where supportive care is available for life threatening reactions.
Danish: • Hvis patienten har høj risiko for nogen som helst allergisk reaktion, må præparatet kun indgives, hvor støttende pleje er til rådighed ved livstruende reaktioner.
English: Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester.
Danish: Det er påvist, at immunglobuliner passerer placenta, især i tredje trimester.
English: In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience (frequency of these reactions is not known (cannot be estimated from the available data)):
Danish: Ud over de bivirkninger, der er observeret i kliniske forsøg, er følgende bivirkninger rapporteret fra erfaringer efter markedsføringen (hyppigheden af disse bivirkninger er ikke kendt (kan ikke estimeres ud fra forhåndenværende data)):
English: Patients may experience side effects (for example dizziness or nausea) during treatment with HyQvia that might affect the ability to drive and use machines.
Danish: Patienterne kan opleve bivirkninger (f.eks. svimmelhed eller kvalme) under behandling med HyQvia, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
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 medicin fremstilles af humant blod eller plasma, tages der visse forholdsregler for at forhindre, at der overføres infektioner til patienter.
English: • Remove the peel-off label from HyQvia vial, which has the product lot number and expiration date, and place the label in your treatment record/log book.
Danish: • Fjern den aftagelige etiket fra HyQvia-hætteglasset, hvor produktets batchnummer og udløbsdato er anført, og sæt etiketten ind i din registrerings-/logbog over behandlingen.
English: Starting treatment
Danish: Behandlingsstart
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Producenterne af disse præparater medtager desuden nogle trin i forarbejdningen af blodet eller plasmaet, som kan inaktivere eller fjerne virus.
English: • Recombinant human hyaluronidase (rHuPH20) Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: • Rekombinant humant hyaluronidase (rHuPH20) Rekombinant humant hyaluronidase er renset glycoprotein fra 447 aminosyrer, der er produceret i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNA-teknologi.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også ukendte eller nyopdagede virus eller andre infektionstyper.
English: MedDRA System Organ Class (SOC)
Danish: MedDRA Systemorganklasse (SOK)
English: Hypersensitivity to IG 10%
Danish: Overfølsomhed over for IG 10 %
English: Monitoring during infusion
Danish: Overvågning under infusionen
English: Glycine, water for injections.
Danish: Glycin, vand til injektionsvæsker.
English: • The medicinal product is for subcutaneous use only, do not administer intravenously.
Danish: • Lægemidlet er udelukkende til subkutan anvendelse og må ikke indgives intravenøst.
English: Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA01
Danish: Farmakoterapeutisk gruppe (humant normalt immunglobulin): immunsera og immunglobuliner: immunglobuliner, normale humane, ATC-kode: J06BA01
English: • Insert needle completely to the wings of the needle with a rapid motion straight into the skin at a 90-degree angle.
Danish: • Indfør kanylen helt til kanylens vinger med en hurtig bevægelse lige ind i huden i en vinkel på 90 grader.
English: See image for infusion site locations.
Danish: Se billedet af infusionsstedernes placering.
English: • When using HyQvia at home, you must perform the infusion in the presence of an assigned guardian person who will help you watch out for allergic reactions, stop the infusion, and get help if necessary.
Danish: • Når du bruger HyQvia hjemme, skal du udføre infusionen, når der er en person til stede, som er udpeget som hjælper, og som hjælper dig med at holde øje med allergiske reaktioner, stoppe infusionen og skaffe hjælp, hvis der er behov for det.
English: The maximum IgA content is 140 micrograms/ml.
Danish: Det maksimale indhold af IgA er 140 mikrogram/ml.
English: The results of the study showed a rate of validated, acute, serious bacterial infections per year during HyQvia treatment of 0.025 (upper limit of the one-sided 99% confidence interval 0.046).
Danish: Resultaterne af studiet viste, at tallet for validerede, akutte, alvorlige bakterieinfektioner om året under behandling med HyQvia var 0,025 (øvre grænse for enkeltsidigt 99 % konfidensinterval var 0,046).
English: Aseptic meningitis syndrome (AMS)
Danish: Aseptisk meningitissyndrom (AMS)
English: The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month.
Danish: Den anbefalede startdosis er en dosis, der giver 400 til 800 mg af det aktive stof pr. kg kropsvægt om måneden.
English: Do not infuse a double dose of HyQvia to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Gravitational oedema/genital swelling was observed subsequent to lower abdominal quadrants administration.
Danish: Gravitationelt ødem/genital hævelse er observeret efter administration i de nedre abdominale kvadranter.
English: The overall rate of infections was less during HyQvia administration than during the three months intravenous administration of IG 10%: the point estimate of the annualized rate of all infections was 2.97 (95% CI: 2.51 to 3.47) for HyQvia and 4.51 (95% CI: 3.50 to 5.69) for intravenous IG 10% infusions.
Danish: Den samlede infektionsrate var mindre under administrationen af HyQvia end under de tre måneders intravenøse administration af IG 10 %: punktestimatet for infektionsraten på årsbasis var 2,97 (95 % CI: 2,51 til 3,47) for HyQvia og 4,51 (95 % CI: 3,50 til 5,69) for infusioner med intravenøst IG 10 %.
English: Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Danish: Studier af toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet hos dyr er ikke gennemførlige i praksis på grund af induktion af og interferens fra de antistoffer, der udvikles mod heterologe proteiner
English: Your doctor or nurse will first infuse HyQvia slowly, and carefully monitor you throughout the first infusions so that any allergic reaction can be detected and treated immediately.
Danish: Din læge eller sygeplejerske vil først infundere HyQvia langsomt og hele tiden overvåge dig omhyggeligt under de første infusioner, så enhver allergisk reaktion kan blive opdaget og behandlet straks.
English: It is recommended that the recombinant human hyaluronidase component be administered at a constant rate and that the rate of administration of the IG 10% should not be increased above the recommended rates, particularly when the patient has just started with HyQvia therapy.
Danish: Det anbefales, at komponenten rekombinant humant hyaluronidase indgives med konstant hastighed, og at administrationshastigheden for IG 10 % ikke øges over den anbefalede hastighed, især når patienten lige er begyndt på behandling med HyQvia.
English: The same indications, dose and frequency of infusion as for adults apply for children and adolescents (0-18 years).
Danish: Der gælder de samme indikationer og den samme dosis og infusionshyppighed for børn og unge (0-18 år) som for voksne.
English: Antibodies against recombinant human hyaluronidase A total of 13 out of 83 subjects who participated in pivotal study developed an antibody capable of binding to recombinant human hyaluronidase (rHuPH20) at least once during the clinical study.
Danish: Antistoffer mod rekombinant humant hyaluronidase I alt 13 ud af 83 personer, som deltog i et pivotalt studie, udviklede et antistof, der var i stand til at binde sig til rekombinant humant hyaluronidase (rHuPH20), mindst en gang i løbet af det kliniske studie.
English: In cases where more than one vial of the medicinal product IG 10% or recombinant human hyaluronidase is required to obtain the required dose of the infusion, the IG 10% and/or recombinant human hyaluronidase should be prepared separately in appropriate solution containers before administration.
Danish: I tilfælde, hvor der er behov for mere end ét hætteglas med lægemidlet IG 10 % eller rekombinant humant hyaluronidase for at opnå den nødvendige dosis til infusionen, skal IG 10 % og/eller rekombinant humant hyaluronidase forberedes separat i egnede opløsningsbeholdere inden administration.
English: The median number of infusion sites per month for HyQvia was 1.09, which is slightly lower than the median number of intravenous IG 10% infusion sites used in this study (1.34), and considerably lower than the median number of infusion sites in the study of subcutaneous administration of IG 10% (21.43).
Danish: Mediantallet for infusionssteder pr. måned med HyQvia var 1,09, hvilket var en smule lavere end mediantallet for infusionssteder med intravenøst IG 10 %, der blev anvendt i dette studie (1,34), og betydeligt lavere end mediantallet for infusionssteder i studiet af subkutan administration af IG 10 % (21,43).