FrancophonIA/ELRC3.0 huggingface dataset:
English: • If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records.
Danish: • Hvis der er kendt anafylakse eller svær overfølsomhed over for humant immunglobulin, bør dette noteres i patientens journal.
English: Remove HyQvia from the box:
Danish: Tag HyQvia ud af æsken:
English: Severe renal adverse reactions have been reported in patients receiving immunoglobulin intravenous treatment, particularly those products containing sucrose (HyQvia does not contain sucrose).
Danish: Alvorlige renale bivirkninger er rapporteret hos patienter, der fik intravenøs behandling med immunglobulin, især de præparater, der indeholder sucrose (HyQvia indeholder ikke sucrose).
English: Local reactions observed during the pivotal clinical study include mild swelling of the site (present in most infusions) due to the large volumes infused, but in general were not considered an adverse reaction unless they caused discomfort.
Danish: De lokale reaktioner, der sås under det pivotale kliniske studie, omfatter let hævelse på stedet (forekommer ved de fleste infusioner) på grund af den store infusionsmængde, men generelt blev dette ikke betragtet som en bivirkning, medmindre det forårsagede ubehag.
English: Posology The dose and dose regimen are dependent on the indication.
Danish: Dosering Dosis og dosering afhænger af indikationen.
English: Infusion site leakage can occur during or after subcutaneous administration of immunoglobulin, including HyQvia.
Danish: Der kan opstå lækage på infusionsstedet under eller efter subkutan administration af immunglobulin, herunder HyQvia.
English: Immunoglobulins are also known as antibodies and are found in healthy people's blood.
Danish: Immunglobuliner er også kendt som antistoffer og findes i raske menneskers blod.
English: Baxalta Innovations GmbH A-1221 Vienna, Austria
Danish: Baxalta Innovations GmbH A-1221 Wien, Østrig
English: The recombinant human hyaluronidase is a protein that makes it easier for the immunoglobulins to be infused (dripped) under the skin and to reach your blood system.
Danish: Det rekombinante humane hyaluronidase er et protein, der gør det lettere for immunglobulinerne at blive infunderet (givet i drop) under huden og nå ud i dit blodkredsløb.
English: • Rotate infusion sites by choosing opposite sides of the body between future infusions.
Danish: • Skift mellem infusionsstederne ved hver gang at vælge den modsatte side af kroppen til den næste infusion.
English: Following subcutaneous administration of HyQvia, peak serum IgG levels are achieved in the recipient's circulation after approximately 3 to 5 days.
Danish: Efter subkutan administration af HyQvia nås maksimale serumniveauer for IgG i modtagerens kredsløb efter ca. 3 til 5 dage.
English: The most frequently reported systemic ARs were headache, fatigue and pyrexia.
Danish: De hyppigst rapporterede systemiske bivirkninger var hovedpine, træthed og pyreksi.
English: It is strongly recommended that every time you use HyQvia, the following data are recorded in your treatment diary: - the date of administration, - the batch number of the medicine, and - the injected volume, flow rate, the number and location of infusion sites.
Danish: Det anbefales stærkt, at følgende data registreres i din behandlingsdagbog, hver gang du bruger HyQvia: - dato for indgivelsen, - medicinens batchnummer og - den injicerede mængde, indgivelseshastighed, antal infusionssteder og infusionsstedernes placering.
English: Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID.
Danish: HyQvias virkning og sikkerhed blev vurderet i et fase 3-forsøg (160603) med 83 patienter med PID.
English: Adequate doses of human normal immunoglobulin may restore abnormally low IgG levels to the normal range.
Danish: Passende doser af humant normalt immunglobulin kan genoprette abnormt lave IgG-niveauer til det normale niveau.
English: AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment.
Danish: AMS kan opstå hyppigere i forbindelse med intravenøs behandling med immunglobulin i høje doser (2 g/kg).
English: • Follow up with physician as directed.
Danish: • Følg op med lægen som anvist.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Danish: Patienter, der oplever bivirkninger under behandlingen, bør vente på, at disse ophører, før de fører motorkøretøj eller betjener maskiner.
English: The safety of HyQvia was evaluated in 4 clinical studies (160602, 160603, 160902, and 161101) in 124 unique patients with PID receiving 3,202 infusions.
Danish: HyQvias sikkerhed blev evalueret i 4 kliniske forsøg (160602, 160603, 160902 og 161101) med 124 unikke patienter med PID (primært immundefektsyndrom), der modtog 3.202 infusioner.
English: The dose of HyQvia was based on the previous treatment with intravenous IG 10% (320 to 1,000 mg/kg body weight /4 weeks) and was individually adapted, ensuring adequate IgG levels throughout the study.
Danish: Dosen af HyQvia var baseret på den tidligere behandling med intravenøst IG 10 % (320 til 1.000 mg/kg kropsvægt i 4 uger) og blev individuelt tilpasset, idet det blev sikret, at IgG-niveauerne var tilstrækkelige under hele studiet.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: You may have to wait for up to 1 year after receiving HyQvia before you can receive your measles vaccine.
Danish: Du skal muligvis vente i op til 1 år, efter at du har fået HyQvia, før du kan få din mæslingevaccine.
English: The contents of each vial are described below:
Danish: Indholdet af hvert hætteglas er bekrevet nedenfor:
English: Subjects ≥ 40 kg
Danish: Personer ≥ 40 kg
English: The cumulative monthly dose of IG 10% should be divided into 1-week, 2-week etc. doses according to the planned treatment intervals with HyQvia.
Danish: Den kumulerede månedlige dosis IG 10 % fordeles på doser hver uge, hver 2. uge osv. i henhold til de planlagte intervaller for behandlingen med HyQvia.
English: Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions.
Danish: Patienter, der behandler sig selv hjemme, og/eller deres værge bør desuden have fået undervisning i at finde tidlige tegn på overfølsomhedsreaktioner.
English: Your doctor or nurse will advise you on the appropriate infusion speed to use when you are infusing HyQvia at home (see section 3, “How to use HyQvia”).
Danish: Din læge eller sygeplejerske vil rådgive dig om, hvilken infusionshastighed det vil være passende at bruge, når du får infusionen hjemme (se punkt 3, ”Sådan skal du bruge HyQvia”).
English: Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected.
Danish: Den kliniske erfaring med immunglobulin tyder på, at der ikke kan forventes nogen skadelige virkninger af IG 10 % på fertiliteten.
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Danish: Administration af immunglobulin kan i en periode på mindst 6 uger og op til 3 måneder påvirke virkningen af levende svækkede virusvacciner som mæslinger, røde hunde, fåresyge og varicella.
English: OUTER CARTON (2.5 G, 5 G, 10 G, 20 G AND 30 G)
Danish: YDRE KARTON (2,5 G, 5 G, 10 G, 20 G OG 30 G)
English: However, antibodies to hyaluronidase did not influence reproduction following immunization of mice, rabbits, sheep, or cynomolgus monkeys.
Danish: Antistoffer mod hyaluronidase påvirkede dog ikke reproduktionen efter immunisering hos mus, kaniner, får eller cynomolgusaber.
English: SC use only.
Danish: Kun s.c. anvendelse.
English: Ask your doctor or pharmacist or nurse if another needle size would be more appropriate for you.
Danish: Spørg din læge, apotekspersonalet eller en sygeplejerske, om en anden kanylestørrelse ville passe bedre til dig.
English: The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older.
Danish: HyQvias farmakokinetik blev evalueret iet klinisk studie hos patienter med PID i alderen 12 år og opefter.
English: • Colour: o The recombinant human hyaluronidase should be clear and colourless.
Danish: • Farve: o Det rekombinante humane hyaluronidase skal være klart og farveløst.
English: 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: Standardforholdsregler til forebyggelse af infektioner som følge af brugen af lægemidler fremstillet af humant blod eller plasma omfatter udvælgelse af donorer, screening af enkelte bloddonationer og plasmapools for specifikke infektionsmarkører og inklusion af effektive produktionstrin til inaktivering/fjernelse af virus.
English: The pharmacokinetic results are presented in the table below, as compared to data for intravenous administration of IG 10% obtained in the same study.
Danish: De farmakokinetiske resultater er vist i skemaet nedenfor, hvor de sammenlignes med data for intravenøs administration af IG 10 %, der blev opnået i samme studie.
English: Do not infuse HyQvia into or around an infected or red swollen area on your skin because it may cause the infection to spread.
Danish: Du må ikke få infusion med HyQvia i eller omkring et inficeret eller rødt og hævet område af huden, da det kan få infektionen til at sprede sig.
English: Wings of needle should lay flat on the skin.
Danish: Kanylens vinger skal ligge fladt op mod huden.
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia.
Danish: Evnen til at føre motorkøretøj og betjene maskiner kan blive nedsat ved nogle bivirkninger, der er forbundet med HyQvia.
English: Do not mix the components of HyQvia prior to administration.
Danish: Bland ikke HyQvias komponenter inden administration.
English: Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”.
Danish: Humant normalt immunglobulin 10 % tilhører en gruppe lægemidler, der kaldes ”humane normale immunglobuliner”.
English: • patients with an inborn inability or reduced ability to produce antibodies (primary immunodeficiencies).
Danish: • patienter med medfødt manglende eller nedsat evne til at producere antistoffer (primære immundefekter).
English: o If either liquid is cloudy or has particles, do not use.
Danish: o Hvis nogen af væskerne er uklare eller indeholder partikler, må de ikke bruges.
English: HyQvia contains two solutions for infusion (drip) under the skin (subcutaneous or SC infusion).
Danish: HyQvia indeholder to opløsninger til infusion (drop) under huden (subkutan eller s.c. infusion).
English: Passive transmission of antibodies to erythrocyte´s surface antigens, (e.g., A, B, D) may interfere with some serological tests for red cell antibodies for example the direct antiglobulin test (DAT, direct Coombs' test).
Danish: Passiv overførsel af antistoffer mod antigener på erytrocytoverfladen, f.eks. A, B, D, kan påvirke nogle serologiske test af antistoffer i røde blodlegemer, for eksempel den direkte antiglobulintest (DAT, direkte Coombs' test).
English: Regular and sufficient doses of HyQvia can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
Danish: Regelmæssige og tilstrækkelige doser HyQvia kan øge et usædvanligt lavt indhold af immunglobulin i dit blod til normale niveauer (erstatningsbehandling).
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents.
Danish: Humant normalt immunglobulin indeholder hovedsageligt immunglobulin G (IgG) med et bredt spektrum af opsoniserende og neutraliserende antistoffer mod smitstoffer.
English: ► Please tell your vaccinating doctor or nurse about your treatment with HyQvia.
Danish: ► Fortæl den læge eller sygeplejerske, som vaccinerer dig, om din behandling med HyQvia.
English: Record the infusion:
Danish: Registrer infusionen:
English: At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1-week dose to up to a 3- or 4-week dose.
Danish: Ved behandlingens indledning anbefales det, at behandlingsintervallerne for de første infusioner gradvist forlænges fra en dosis hver uge til op til en dosis hver 3. eller 4. uge.
English: - if you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase or any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
Danish: - hvis du er allergisk over for immunglobulin, hyaluronidase, rekombinant hyaluronidase eller et af de øvrige indholdsstoffer i HyQvia (angivet i punkt 6, ”Pakningsstørrelser og yderligere oplysninger”).
English: If you think that you have missed a dose speak to your doctor as soon as possible.
Danish: Hvis du tror, at du har glemt en dosis, skal du tale med din læge hurtigst muligt.
English: No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies.
Danish: Der blev ikke forbundet nogen uønskede virkninger på graviditeten og fostrets udvikling med anti-rHuPH20-antistoffer.
English: Certain side effects, such as headache, chills, or body aches, may be reduced by slowing the infusion rate.
Danish: Visse bivirkninger, såsom hovedpine, kuldegysninger eller smerter i kroppen, kan mindskes ved at sænke infusionshastigheden.
English: He or she will decide whether to slow down the infusion rate or stop the infusion completely.
Danish: De vil beslutte, om infusionshastigheden skal sænkes, eller om infusionen skal stoppes helt.
English: • patients with low antibody production prior and after transplantation of bone marrow cells from another person.
Danish: • patienter med lav antistofproduktion før og efter transplantation af knoglemarvsceller fra en anden person.
English: Home treatment
Danish: Hjemmebehandling
English: Subjects < 40 kg
Danish: Personer < 40 kg
English: The IG 10% component should be infused using a pump.
Danish: Komponenten IG 10 % skal infunderes med en pumpe.
English: It has a distribution of IgG subclasses closely proportional to that in native human plasma.
Danish: Proportionaliteten i dets fordeling af IgG-subklasser er tæt på fordelingen i naturligt humant plasma.
English: There were two instances of transient genital oedema, one considered severe, that resulted from diffusion of the medicinal product from the infusion site in the abdomen.
Danish: Der var to tilfælde af forbigående genitalt ødem (hvoraf det ene blev betragtet som svært), som skyldtes diffusion af lægemidlet fra infusionsstedet i maven.
English: • Note: Your healthcare professional may recommend using a “Y” connector (for more than one site) or other needle set configuration.
Danish: • Bemærk: Sundhedspersonalet kan anbefale at bruge en Y-kobling (til flere indstikssteder) eller en anden kanylesætsammensætning.
English: You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock.
Danish: Du kan opleve et pludseligt fald i blodtrykket og i enkelstående tilfælde anafylaktisk chok.
English: • When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur.
Danish: • når behandlingen gives hjemme, bør der være støtte til rådighed fra en anden person, der kan tage ansvaret for at behandle bivirkninger eller tilkalde hjælp, hvis en alvorlig bivirkningsreaktion skulle opstå.
English: In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
Danish: I tilfælde af bivirkninger skal administrationshastigheden enten reduceres, eller infusionen skal ophøre.
English: In case subcutaneous infusion of HyQvia is used for home treatment, therapy should be initiated and monitored by a physician experienced in the guidance of patients for home treatment.
Danish: I de tilfælde, hvor subkutan infusion med HyQvia anvendes i hjemmet, skal behandlingen indledes og overvåges af en læge med til behandling erfaring i vejledning af patienter i hjemmebehandling.
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Danish: Substitutionsbehandlingen indledes og overvåges under opsyn af en læge med erfaring i behandling af immundefekter.
English: Data from the clinical trials of HyQvia show that serum IgG trough levels can be maintained by dosing regimens of 320 to 1,000 mg/kg body weight/4 weeks given at intervals of 3- or 4-weeks.
Danish: Data fra det kliniske forsøg med HyQvia viser, at dalniveauerne for IgG i serum kan bevares ved doseringsregimer på 320 til 1.000 mg/kg kropsvægt for hver 4 uger med administrationsintervaller på 3 eller 4 uger.
English: The suggested site(s) for the infusion of the medicinal product are the middle to upper abdomen and thighs.
Danish: Det/de foreslåede sted(er) til infusion af lægemidlet er maven og lårene.
English: Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Danish: Overfølsomhed over for humant immunglobulin, især i meget sjældne tilfælde af IgA-mangel når patienten har antistoffer mod IgA.
English: Long-term animal studies to evaluate the carcinogenic or mutagenic potential of recombinant human hyaluronidase have not been conducted.
Danish: Langtidsstudier af dyr til vurdering af rekombinant humant hyaluronidases karcinogene eller mutagene potentiale er ikke gennemført.
English: These antibodies bind to red blood cells (RBC) epitops (which may be detected as a positive direct antiglobulin test [DAT, (Coombs' test)] and, rarely, may cause haemolysis.
Danish: Disse antistoffer bindes til de røde blodlegemers epitoper (som kan spores som en positiv direkte antiglobulintest [DAT, (Coombs' test)]) og kan i sjældne tilfælde forårsage hæmolyse.
English: ► In such cases, you will be closely monitored during your first infusion and for the first hour after your infusion has stopped.
Danish: ► I sådanne tilfælde vil du blive overvåget tæt, mens du får din første infusion, og i den første time efter at infusionen er stoppet.
English: • If possible, combine all of the recombinant human hyaluronidase needed for the entire dose of IgG into the same syringe.
Danish: • Hvis det er muligt, skal alt det rekombinante humane hyaluronidase, der skal bruges til hele dosen med IgG, samles i den samme sprøjte.
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be treated with HyQvia only under close medical supervision.
Danish: Patienter med anti-IgA-antistoffer, for hvem behandling med subkutane IgG-præparater er den eneste mulighed, må kun behandles med HyQvia under tæt opsyn af en læge.
English: Partially used vials should be discarded.
Danish: Delvist brugte hætteglas skal kasseres.
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in HyQvia, are protective.
Danish: Immunglobuliner er ikke blevet forbundet med infektioner med hepatitis A eller parvovirus B19, muligvis fordi antistofferne mod disse infektioner, som findes i HyQvia, beskytter patienten.
English: Do not use the product if it does not have the cap.
Danish: Brug ikke produktet, hvis låget ikke sidder på.
English: The product should not be infused at or around an infected or acutely inflamed area due to the potential risk of spreading a localized infection.
Danish: Lægemidlet må ikke infunderes i eller omkring et inficeret område eller et område med akut inflammation på grund af fare for spredning af en lokal infektion.
English: Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained.
Danish: Behandlingen med HyQvia vil blive påbegyndt af din læge eller sygeplejerske, men du får muligvis lov til at bruge medicinen hjemme, når du har fået de første infusioner under medicinsk overvågning, og du (og/eller din hjælper) er blevet oplært tilstrækkeligt i det. Du og din læge vil afgøre, om du kan bruge HyQvia hjemme.
English: Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Danish: Der skal overvåges for tegn og symptomer på trombose, og blodviskociteten skal vurderes hos patienter, der har risiko for hyperviskositet.
English: Prepare the infusion site:
Danish: 10. Forbered infusionsstedet:
English: Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Danish: Hvert hætteglas med 25 ml indeholder: 2,5 g humant normalt immunglobulin Hvert hætteglas med 50 ml indeholder: 5 g humant normalt immunglobulin Hvert hætteglas med 100 ml indeholder: 10 g humant normalt immunglobulin Hvert hætteglas med 200 ml indeholder: 20 g humant normalt immunglobulin Hvert hætteglas med 300 ml indeholder: 30 g humant normalt immunglobulin
English: Development of non-neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.
Danish: Udvikling af ikke-neutraliserende antistoffer mod den rekombinante humane hyaluronidasekomponent er rapporteret hos patienter, der har fået HyQvia i kliniske studier.
English: Place all gathered supplies and open them as directed by your healthcare professional.
Danish: Læg alle de indsamlede ting frem, og åbn dem i henhold til sundhedspersonalets instruktioner.
English: • Repeat Step 6, if more than one vial of recombinant human hyaluronidase is needed for your dose.
Danish: • Gentag trin 6, hvis der skal bruges mere end et hætteglas med rekombinant humant hyaluronidase til din dosis.
English: Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins.
Danish: Immunglobulinprodukter indeholder antistoffer mod blodtyper (f.eks. A, B, D), som kan optræde som hæmolysiner.
English: Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Parameter
Danish: Farmakokinetiske parametre for HyQvia sammenlignet med intravenøs administration af IG 10 %.
English: Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Danish: Ophør af behandlingen med immunglobulin kan medføre bedring i AMS inden for adskillige dage uden følgevirkninger.
English: Administer the human normal immunoglobulin 10% with a pump at the rates prescribed by your healthcare professional and start the infusion.
Danish: Klargør humant normalt immunglobulin 10 % med en pumpe med de hastigheder, som sundhedspersonalet har angivet, og start infusionen.
English: Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan.
Danish: Rekombinant humant hyaluronidase er en opløselig rekombinant form af humant hyaluronidase, der øger det subkutane vævs permeabilitet gennem midlertidig depolymerisering af hyaluronan.