FrancophonIA/ELRC3.0 huggingface dataset:
English: This will be increased step-wise to larger doses at 3- to 4-week intervals with the next infusions.
Danish: Denne dosis vil blive øget trinvist til større doser, som gives i de næste infusioner med 3 til 4 ugers mellemrum.
English: HyQvia should only be used by pregnant and breast-feeding women after discussion with your physician.
Danish: HyQvia må kun anvendes af gravide og ammende kvinder efter samråd med lægen.
English: 35.7 (32.4 to 40.4)
Danish: 35,7 (32,4 til 40,4)
English: Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits.
Danish: Studier af udviklings- og reproduktionstoksikologi er udført med rekombinant humant hyaluronidase hos mus og kaniner.
English: • The human normal immunoglobulin 10% of HyQvia may be infused either o by pooling from the vials either into larger syringe (a) or an infusion bag (b) as directed by your healthcare professional, depending upon the pump to be used; or o directly from the IG vial (c).
Danish: • Komponenten humant normalt immunglobulin 10 % i HyQvia indgives enten o ved at samle indholdet fra hætteglassene enten i den største sprøjte (a) eller en infusionspose (b) i henhold til instruktionerne fra sundhedspersonalet, alt afhængigt af hvilken pumpe der bruges; eller o direkte fra hætteglasset IG (c).
English: In all other cases you should be monitored during the infusion and for at least 20 minutes after you receive HyQvia for the first few infusions.
Danish: I alle andre tilfælde bør du blive overvåget under infusionen og i mindst 20 minutter de første gange, efter at du har fået HyQvia.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • Visually inspect both components of HyQvia for discoloration and particulate matter prior to administration.
Danish: • Kontrollér begge HyQvias komponenter visuelt for misfarvning og partikler før administration.
English: The recombinant human hyaluronidase of HyQvia contains small amounts (4.03 mg per ml) of sodium.
Danish: Det rekombinante humane hyaluronidase i HyQvia indeholder små mængder (4,03 mg pr. ml) natrium.
English: • initially infusing the product slowly (see section 4.2).
Danish: • præparatet infunderes langsomt i starten (se pkt.
English: • Gently press a small piece of gauze over the needle site and cover with a protective dressing.
Danish: • Tryk blidt et lille stykke gaze over indstiksstedet, og dæk det med et beskyttende plaster.
English: No skin changes were observed that did not resolve during the clinical study.
Danish: Der blev ikke set hudforandringer, som ikke forsvandt under det kliniske studie.
English: Human normal immunoglobulin (SCIg)
Danish: Humant normalt immunglobulin (SCIg)
English: Infusion speed
Danish: Infusionshastighed
English: VIAL LABEL RECOMBINANT HUMAN HYALURONIDASE (2.5 ML, 5 ML, 10 ML, 15 ML)
Danish: HÆTTEGLASETIKET REKOMBINANT HUMANT HYALURONIDASE (2,5 ML, 5 ML, 10 ML, 15 ML)
English: The recombinant human hyaluronidase of HyQvia acts locally.
Danish: Det rekombinante humane hyaluronidase i HyQvia virker lokalt.
English: Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: Overfølsomhed over for det aktive stof (IgG) eller over for et eller flere af hjælpestofferne anført i punkt 6.1 (se pkt.
English: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Danish: • Primære immundefektsyndromer med nedsat antistofproduktion (se pkt.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Danish: Humant normalt immunglobulin indeholder de IgG-antistoffer, der findes i den normale population.
English: Replacement therapy The medicinal product should be administered via the subcutaneous route.
Danish: Substitutionsbehanding Lægemidlet skal administreres subkutant.
English: These antibodies were not capable of neutralizing recombinant human hyaluronidase.
Danish: Disse antistoffer var ikke i stand til at neutralisere rekombinant humant hyaluronidase.
English: • If instructed by your health care professional, clean the infusion site(s) with an alcohol swab.
Danish: • Hvis sundhedspersonalet har instrueret dig i dette, skal du rense infusionsstedet (-stederne) med en spritserviet.
English: There is reassuring clinical evidence 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 evidens med hensyn til manglende overførsel af hepatitis A eller parvovirus B19 sammen med immunglobulin, og det antages desuden, at antistofindholdet bidrager i væsentlig grad til virussikkerheden.
English: • If more than one vial is required for a full dose, spike subsequent vials after the first vial has been fully administered.
Danish: • Hvis der er behov for mere end et hætteglas til en hel dosis, skal spyddet først indføres i de efterfølgende hætteglas, efter at det første hætteglas er helt indgivet.
English: The patient will be instructed in infusion techniques, the use of an infusion pump or syringe driver, the keeping of a treatment diary, recognition of possible severe adverse reactions and measures to be taken in case these occur.
Danish: Patienten vil blive instrueret i infusionsteknik, brug af infusionspumpe eller sprøjtepumpe, føring af behandlingsdagbog, genkendelse af mulige alvorlige bivirkninger og forholdsregler, der skal tages, hvis de forekommer.
English: The IG 10% component contains trace amounts of sodium.
Danish: Komponenten IG 10 % indeholder spormængder af natrium.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Danish: Den kliniske erfaring med immunglobuliner tyder på, at der ikke kan forventes skadelige virkninger på graviditetsforløbet eller på fostret og det nyfødte barn.
English: Flush the pump tubing when the infusion is complete if instructed by your healthcare professional:
Danish: Skyl pumpeslangerne, når infusionen er færdig, hvis du har fået instruktion i dette af sundhedspersonalet:
English: Live attenuated virus vaccines
Danish: Levende svækkede virusvacciner
English: Caution should be exercised in patients with pre-existing risk factors for thromboembolic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Danish: Der skal udvises forsigtighed ved patienter med allerede eksisterende risikofaktorer for tromboemboliske hændelser (som høj alder, hypertension, diabetes mellitus og tidligere vaskulær sygdom eller trombosetilfælde, patienter med erhvervet eller nedarvede trombofililidelser, patienter med længere perioder med immobilisering, svært hypovolæmiske patienter, patienter med sygdomme, som øger blodets viskositet).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om HyQvia findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Remove the needle set by loosening the dressing on all edges.
Danish: • Fjern kanylesættet ved at løsne plasteret i alle kanterne.
English: Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary.
Danish: Ved enhver mistanke om allergisk reaktion eller en reaktion, der kan være anafylaktisk, efter administration af rekombinant humant hyaluronidase, bør infusionen straks ophøre, og medicinsk standardbehandling gives ved behov
English: Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma.
Danish: Humant normalt immunglobulin og humant serumalbumin (stabilisator for rekombinant humant hyaluronidase) fremstilles af humant plasma.
English: The following ADRs are not listed but also calculated in the frequency for Local reactions: feeling hot, infusion site paresthesia.
Danish: Følgende bivirkninger er ikke anført, men medregnes også i hyppigheden for lokale reaktioner: varmefølelse, paræstesi på infusionsstedet.
English: Subsequent 2 to 3 Infusions (ml/hour/infusion site)
Danish: Efterfølgende 2-3 infusioner (ml/time/ infusionssted)
English: • ensuring that patients are carefully monitored for any symptoms throughout the infusion period.
Danish: • patienterne overvåges omhyggeligt i hele infusionsperioden for at se, om der er symptomer af nogen art.
English: IG 10% is a clear or slightly opalescent and colourless or pale yellow solution.
Danish: IG 10 % er en klar eller let opaliserende og farveløs eller svagt gul opløsning.
English: • Patients should be informed of the early signs of anaphylaxis/hypersensitivity (hives, pruritus, generalized urticaria, tightness of the chest, wheezing, and hypotension).
Danish: • Patienterne bør informeres om de tidlige tegn på anafylakse/overfølsomhedsreaktioner (nældefeber, pruritus, generaliseret urticaria, thoraxkonstriktion, hvæsende åndedræt og hypotension).
English: Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis.
Danish: Modtagere af immunglobulinpræparater bør overvåges for at se, om der er kliniske tegn og symptomer på hæmolyse.
English: • Throw away any unused product in the vial and the disposable supplies as recommended by your healthcare professional.
Danish: • Bortskaf alt ikke anvendt lægemiddel i hætteglasset samt engangsudstyr i henhold til sundhedspersonalets anbefalinger.
English: Any change of needle size would have to be supervised by the treating physician.
Danish: Et eventuelt skift af kanylestørrelse skal overvåges af den behandlende læge.
English: Marketing Authorisation Holder: Baxalta Innovations GmbH Industriestrasse 67
Danish: Indehaver af markedsføringstilladelsen: Baxalta Innovations GmbH Industriestrasse 67
English: Patients should be informed about first symptoms which encompass severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Danish: Patienterne skal informeres om de første symptomer, som omfatter alvorlig hovedpine, nakkestivhed, døsighed, feber, fotofobi, kvalme og opkastning.
English: This medicine contains trace amounts of immunoglobulin A (IgA) (not more than 140 micrograms/ml, 37 micrograms on average).
Danish: Dette lægemiddel indeholder spormængder af immunglobulin A (IgA) (højst 140 mikrogram/ml, 37 mikrogram i gennemsnit).
English: First Two Infusions (ml/hour/infusion site)
Danish: To første infusioner (ml/time/ infusionssted)
English: Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days.
Danish: Patienterne bør orienteres om at indberette eventuelle kroniske inflammationer, små knuder eller inflammation, der opstår på infusionsstedet og varer mere end nogle få dage.
English: Information on the source material of HyQvia
Danish: Information om materialet til HyQvia
English: Check for proper needle placement before starting the infusion if instructed by your healthcare professional.
Danish: Kontroller, at kanylen er placeret rigtigt, før du begynder på infusionen, hvis du har fået instruktion i dette af sundhedspersonalet.
English: The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain.
Danish: De hyppigste bivirkninger, der er rapporteret efter markedsføringen under brug af rekombinant humant hyaluronidase i tilsvarende præparater, der blev indgivet subkutant til dispersion og absorption af subkutant administrerede væsker og lægemidler, var lette lokale reaktioner på infusionsstedet,
English: What you need to know before you use HyQvia
Danish: Det skal du vide, før du begynder at bruge HyQvia
English: No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated.
Danish: Der kunne ikke påvises nogen tidsmæssig forbindelse mellem bivirkninger og forekomsten af antistofferne anti-rHuPH20.
English: HyQvia may reduce the effect of some virus vaccines such as measles, rubella, mumps and chicken pox (live virus vaccines).
Danish: HyQvia kan nedsætte virkningen af nogle virusvacciner, såsom mæslinger, røde hunde, fåresyge og skoldkopper (vacciner med levende virus).
English: First, the full dose of recombinant human hyaluronidase solution is infused at a rate of 1 to 2 ml/minute per infusion site or as tolerated.
Danish: Først infunderes hele dosen af den rekombinante humane hyaluronidaseopløsning med en hastighed på 1 til 2 ml/minut for hvert infusionssted eller efter tolerance.
English: Infusion for subcutaneous use for HyQvia hyaluronidase
Danish: Infusionsvæske til subkutan anvendelse til HyQvia hyaluronidase
English: Remainder of infusion
Danish: Resterende infusioner
English: No adverse effects on fertility were observed in mice, rabbits and cynomolgus monkeys exposed to antibodies that bind to recombinant human hyaluronidase and species-specific hyaluronidase.
Danish: Der er ikke observeret negativ påvirkning af fertiliteten hos mus, kaniner og cymolgusaber, der har været eksponeret for antistoffer, som bindes til rekombinant humant hyaluronidase og artsspecifikt hyaluronidase.
English: 1.4 (1.2 to 1.4)
Danish: 1,4 (1,2 til 1,4)
English: Cases of transient aseptic meningitis, transient hemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4.
Danish: Tilfælde af forbigående aseptisk meningitis, forbigående hæmolytiske reaktioner, stigning i serumkreatininniveauet og/eller akut nyresvigt er set med humant normalt immunglobulin, se pkt.
English: • Check infusion site(s) occasionally throughout the infusion for dislodgement or leaking.
Danish: • Kontroller infusionsstedet (-stederne) af og til under hele infusionen for at se, om noget har flyttet sig eller lækker.
English: Only two instances of local adverse reactions were severe, infusion site pain and infusion site swelling.
Danish: Kun to tilfælde af lokale bivirkninger var svære: smerter på infusionsstedet og hævelse på infusionsstedet.
English: HyQvia contains sodium
Danish: HyQvia Indeholder natrium
English: • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
Danish: • Hypogammaglobulinæmi og recidiverende bakterieinfektioner hos patienter med kronisk lymfatisk leukæmi, hvor profylaktiske antibiotika ikke har virket eller er kontraindiceret.
English: Patients previously treated with immunoglobulin administered subcutaneously For patients currently being administered immunoglobulin subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment, but may be adjusted to 3- or 4-weeks interval.
Danish: Patienter, der tidligere er behandlet med immunglobulin administreret subkutant Til patienter, hvis nuværende behandling med immunglobulin sker subkutant, er den indledende dosis HyQvia den samme som ved subkutan behandling, men kan justeres til et interval på 3 eller 4 uger.
English: In these studies, maternal antibodies to recombinant human hyaluronidase were transferred to offspring in utero.
Danish: I disse studier blev moderens antistoffer mod rekombinant humant hyaluronidase overført til afkommet in utero.
English: • If using a pump, prepare the pump to infuse the recombinant human hyaluronidase at an initial rate per infusion site of 60 to 120 ml/hour and increase as tolerated.
Danish: • Hvis du bruger en pumpe, gør du pumpen klar til at give infusionen med det rekombinante humane hyaluronidase med en starthastighed på 60 til 120 ml/time for hvert infusionssted og øge hastigheden efter, hvad du tåler.
English: You may be allergic to immunoglobulins without knowing it. Allergic reactions such as sudden fall in blood pressure or anaphylactic shock (a sharp fall in blood pressure with other symptoms such as swelling of the throat, breathing difficulties and skin rash) are rare but they can occasionally occur even if you have not previously had problems with similar treatments.
Danish: Allergiske reaktioner såsom pludseligt fald i blodtrykket eller anafylaktisk chok (et brat fald i blodtrykket med andre symptomer såsom hævelse i halsen, åndedrætsbesvær og hududslæt) er sjældne, men de kan af og til forekomme, selvom du ikke tidligere har haft problemer med lignende behandlinger.
English: The following side effects have been observed with infusion of medicines like human normal immunoglobulin 10% given under the skin (subcutaneously).
Danish: Følgende bivirkninger er blevet set ved infusion af medicin som humant normalt immunglobulin 10 %, der gives under huden (subkutant).
English: 90.52 (83.8 to 9)
Danish: 90,52 (83,8 til 98,4)
English: Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Danish: Visse bivirkninger kan opstå hyppigere hos patienter, der får humant normalt immunglobulin første gang, eller i sjældne tilfælde når der skiftes fra et andet immunglobulinpræparat, eller når der har været en lang pause siden den foregående infusion.
English: Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms.
Danish: Patienterne skal informeres om de første symptomer på tromboemboliske hændelser, herunder stakåndethed, smerter og hævelse i en ekstremitet, fokalneurologiske udfald og brystsmerter, og skal rådes til at kontakte deres læge straks efter symptomernes indtræden.
English: • Secure the needle(s) in place by putting a sterile clear bandage over the needle.
Danish: • Fastgør kanylen(kanylerne) til stedet ved at sætte et sterilt klart plaster over kanylen.
English: You will be instructed in: - Germ-free (aseptic) infusion techniques, - The use of an infusion pump or syringe driver (if needed), - Keeping a treatment diary, and - Measures to be taken in case of severe side effects.
Danish: Du vil få instruktion i: - Bakteriefri (aseptisk) infusionsteknik - Brug af infusionspumpe eller sprøjtepumpe (ved behov), - At føre en behandlingsdagbog - Forholdsregler, der skal tages i tilfælde af alvorlige bivirkninger.
English: Fill the administration pump tubing and set aside until the recombinant human hyaluronidase has been administered.
Danish: Fyld administrationspumpens slanger, og lad dem ligge, indtil det rekombinante humane hyaluronidase er indgivet.
English: Important information about some of the ingredients of HyQvia
Danish: Vigtige oplysninger om visse af indholdsstofferne i HyQvia
English: Rare (≥1/10,000 to
Danish: Sjælden (≥1/10.000 til
English: One ml of the solution in this vial contains 100 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin G (IgG).
Danish: En ml af opløsningen i dette hætteglas indeholder 100 mg humant normalt immunglobulin, hvoraf mindst 98 % er immunglobulin G (IgG).
English: Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins.
Danish: Arterielle og venøse tromboemboliske hændelser, herunder myokardieinfarkt, slagtilfælde, dyb venetrombose og lungeemboli, er blevet forbundet med brugen af immunglobuliner.
English: No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults.
Danish: Der sås ingen væsentlige forskelle i HyQvias farmakodynamiske virkning eller sikkerhed for pædiatriske patienter i forhold til voksne.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Danish: Især patienter, der ikke tidligere har fået humant normalt immunglobulin, patienter, der er skiftet fra et alternativt præparat, eller hvor der har været en lang pause siden den foregående infusion, bør overvåges under den første infusion og i den første time efter den første infusion, så mulige tegn på bivirkninger opdages.
English: In the clinical study with HyQvia, no differences in the plasma IgG trough levels were observed between adult and paediatric patients.
Danish: I det kliniske studie af HyQvia sås der ingen forskelle i dalniveauerne for IgG i plasma hos voksne i forhold til pædiatriske patienter.
English: The effects of antibodies to the recombinant human hyaluronidase component of HyQvia on the human embryo or on human foetal development are currently unknown (see section 5.3).
Danish: Virkningerne af antistoffer mod den rekombinante humane hyaluronidasekomponent i HyQvia på det humane embryo eller på udviklingen af det humane foster er ukendt på nuværende tidspunkt (se pkt.
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Danish: I sjældne tilfælde kan humant normalt immunglobulin inducere et blodtryksfald med anafylaktisk reaktion, selv hos patienter, der har tålt tidligere behandling med humant normalt immunglobulin.
English: The other ingredients of this vial are glycine and water for injections.
Danish: Øvrige indholdsstoffer i dette hætteglas: glycin og vand til injektionsvæsker.
English: Vomiting, nausea, abdominal pain (including abdominal upper and lower pain and tenderness), diarrhoea
Danish: Opkastning, kvalme, abdominalsmerter (herunder smerter i øvre og nedre abdomen samt ømhed), diarré
English: Known systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase.
Danish: Kendt systemisk overfølsomhed over for hyaluronidase eller rekombinant humant hyaluronidase.
English: • patients with a certain kind of blood cancer (chronic lymphocytic leukaemia) which leads to a lack of antibody production and recurrent infections when preventative antibiotics have failed.
Danish: • patienter med en bestemt type blodkræft (kronisk lymfatisk leukæmi), som medfører manglende antistofproduktion og tilbagevendende infektioner, når forebyggende antibiotika ikke har virket.
English: Infuse the full dose per site of IG 10% through the same subcutaneous needle set within 10 minutes of the recombinant human hyaluronidase.
Danish: Den fulde dosis IG 10 % infunderes pr. sted gennem det samme subkutane kanylesæt inden for 10 minutter efter det rekombinante humane hyaluronidase.
English: What HyQvia is
Danish: Hvad er HyQvia?
English: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Danish: Immunglobuliner udskilles i mælken og kan bidrage til at beskytte det nyfødte barn mod patogener, der passerer gennem slimhinden.
English: 93.9 (89.1 to 102.1)
Danish: 93,9 (89,1 til 102,1)
English: Do not mix the components of this medicinal product.
Danish: Lægemidlets komponenter må ikke blandes.