FrancophonIA/ELRC3.0 huggingface dataset:
English: Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Danish: I sjældne tilfælde kan humant normalt immunglobulin forårsage et pludseligt blodtryksfald og i enkeltstående tilfælde anafylaktisk chok, selv når patienten ikke har udvist nogen overfølsomhed over for tidligere administration.
English: Administer the human normal immunoglobulin 10%: After infusing all of the content of the smaller syringe (recombinant human hyaluronidase), remove the syringe from the hub of the needle set.
Danish: Indgiv humant normalt immunglobulin 10 %: Efter at du har fået infusionen af hele indholdet af den mindste sprøjte (rekombinant humant hyaluronidase), fjerner du sprøjten fra kanylesættets holder.
English: There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase.
Danish: Der var ingen øget forekomst eller sværhedsgrad af bivirkninger hos de patienter, der udviklede antistoffer mod humant hyaluronidase.
English: The other ingredients are sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid (EDTA) disodium, calcium chloride and water for injections (see also section 2, “HyQvia contains sodium”).
Danish: Øvrige indholdsstoffer: natriumchlorid, natriumfosfat, humant albumin, ethylendiamintetraeddikesyre (EDTA) dinatrium, calciumchlorid og vand til injektionsvæsker (se også punkt 2, ”HyQvia indeholder natrium”).
English: Myalgia, musculoskeletal chest pain
Danish: Myalgi, muskuloskeletale brystsmerter
English: The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients.
Danish: Den længste eksponering for voksne var 3,8 år og for pædiatriske patienter 3,3 år.
English: Do not mix the two vials prior to administration.
Danish: Bland ikke de to hætteglas inden administration.
English: Human normal immunoglobulin (IG 10%) vial 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl rubber).
Danish: Hætteglas med humant normalt immunglobulin (IG 10 %) 25, 50, 100, 200 eller 300 ml opløsning i et hætteglas (type I-glas) med prop (bromobutylgummi).
English: • Remove blue protective caps to expose the vial stoppers.
Danish: • Fjern de blå beskyttelseslåg for at fritlægge hætteglassenes propper.
English: ► If you experience any side effects, you or your guardian must stop the infusion immediately and contact a doctor.
Danish: ► Hvis du oplever bivirkninger af nogen art, skal du eller din hjælper straks stoppe infusionen og søge lægehjælp.
English: The vials should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Hætteglassene skal kontrolleres visuelt for misfarvning og partikler før administration.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses.
Danish: Forholdsreglerne anses for effektive over for kappeklædte virus, såsom human immundefektvirus (hiv), hepatitis B-virus (HBV) og hepatitis C-virus (HCV), og over for de ikke-kappeklædte virus hepatitis A (HAV) og parvovirus B19.
English: Each vial of IG 10% is supplied with the appropriate corresponding quantity of recombinant human hyaluronidase as stated in the table below.
Danish: Hvert hætteglas med IG 10 % er forsynet med en passende tilsvarende mængde rekombinant humant hyaluronidase som anført i skemaet nedenfor.
English: Patients previously treated with immunoglobulin administered intravenously For patients switching directly from intravenous administration of immunoglobulin, or who have a previous intravenous dose of immunoglobulin that can be referenced, the medicinal product should be administered at the same dose and at the same frequency as their previous intravenous immunoglobulin treatment.
Danish: Patienter, der tidligere er behandlet med immunglobulin administreret intravenøst Til patienter, der skifter direkte fra intravenøs administration af immunglobulin, eller hvor dosis er angivet for tidligere intravenøs administration af immunglobulin, indgives lægemidlet med samme dosis og hyppighed som i den tidligere intravenøse behandling med immunglobulin.
English: Sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid disodium, calcium chloride, water for injections.
Danish: Natriumchlorid, natriumfosfat, humant albumin, ethylendiamintetraeddikesyre, dinatriumsalt, calciumchlorid, vand til injektionsvæsker.
English: 45.3 (41.0 to 60.2)
Danish: 45,3 (41,0 til 60,2)
English: Human normal immunoglobulin 10%
Danish: Humant normalt immunglobulin 10 %
English: Solution for infusion (infusion).
Danish: Infusionsvæske, opløsning (infusion).
English: o The human normal immunoglobulin 10% should be clear and colourless or pale yellow.
Danish: o Humant normalt immunglobulin 10 % skal være klart og farveløst eller svagt gul.
English: In addition to the adverse reactions listed above, the following additional adverse reactions have been reported for subcutaneously administered immunoglobulin products:
Danish: Ud over de bivirkninger, der er observeret i kliniske forsøg, er følgende bivirkninger rapporteret for subkutant administrerede immunglobulinpræparater:
English: • patients with a specific cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).
Danish: • patienter med specifik knoglemarvskræft (myelomatose) og manglende antistofproduktion med tilbagevendende infektioner, som ikke har reageret på vaccine mod visse bakterier (pneumokokker).
English: If HyQvia is accidentally administered into a blood vessel patients could develop shock.
Danish: Hvis HyQvia ved et uheld administreres i en blodåre, kan der opstå chok hos patienten.
English: The measures taken for the manufacture of HyQvia are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and for the non-enveloped hepatitis A virus and parvovirus B19.
Danish: De forholdsregler, der tages ved fremstillingen af HyQvia, anses for effektive over for kappeklædte virus, såsom hiv (human immundefektvirus), hepatitis B-virus og hepatitis C-virus og over for det ikke-kappeklædte hepatitis A-virus og parvovirus B19.
English: • Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.
Danish: • Hypogammaglobulinæmi og recidiverende bakterieinfektioner hos patienter med myelomatose.
English: The following rare side effects have been observed in patients using medicines like human normal immunoglobulin 10% given into a vein (intravenously).
Danish: Følgende sjældne bivirkninger er set hos patienter, der bruger medicin som humant normalt immunglobulin 10 %, der gives i en blodåre (intravenøst).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: • Allow refrigerated product to come to room temperature before use.
Danish: • Lad nedkølet lægemiddel få stuetemperatur inden brug.
English: Home treatment Before you start home treatment you should assign a person as guardian.
Danish: Inden du begynder på hjemmebehandling, bør du have en aftale med en person, som skal være din hjælper.
English: • Point the syringe tip up and remove any air bubbles by pointing the syringe tip up and gently tapping the syringe with your finger.
Danish: • Peg sprøjtespidsen opad, og fjern eventuelle luftbobler ved at pege sprøjtespidsen opad og banke blidt på sprøjten med fingeren.
English: 10.4 (9.4 to 11.2)
Danish: 10,4 (9,4 til 11,2)
English: If you have an infusion site leakage
Danish: Hvis der er en utæthed ved infusionsstedet
English: These reactions have not been seen with HyQvia, but there is a small possibility that someone using HyQvia may get them: Blood clots in blood vessels (thromboembolic reactions) leading to heart attack, stroke, blockage of deep veins, or of blood vessels supplying the lung (pulmonary embolism), kidney disorder or failure, destruction of red blood cells (haemolysis).
Danish: Disse reaktioner er ikke set med HyQvia, men der er en lille mulighed for, at en person, der får HyQvia, kan få dem: Blodpropper i blodkar (tromboemboliske reaktioner), der medfører hjerteanfald, slagtilfælde, blodprop i de dybe vener eller i de blodkar, der forsyner lungerne (lungeemboli), nyresygdom eller nyresvigt, destruktion af røde blodlegemer (hæmolyse).
English: Erythema, rash (including erythematous, papular, maculo-papular), pruritus, urticaria
Danish: Erytem, udslæt (herunder erytematøst, papuløst, makulopapuløst), pruritus, urticaria
English: Immunoglobulins are normal constituents of the human body.
Danish: Immunglobuliner er normale bestanddele i den menneskelige krop.
English: No long-term (chronic) changes in the skin were observed in the clinical studies.
Danish: Der sås ingen langvarige (kroniske) hudforandringer i de kliniske studier.
English: What HyQvia is used for
Danish: Hvad bruges HyQvia til?
English: Common (≥1/100 to <1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: The product should be brought to room temperature before use.
Danish: Lægemidlet bør have stuetemperatur før brug.
English: VIAL LABEL HUMAN NORMAL IMMUNOGLOBULIN (5 G, 10 G, 20 G AND 30 G)
Danish: HÆTTEGLASETIKET HUMANT NORMALT IMMUNGLOBULIN (5 G, 10 G, 20 G OG 30 G)
English: The vial of immunoglobulins has been prepared from the blood of healthy people.
Danish: Hætteglasset med immunglobuliner er fremstillet af blod fra raske mennesker.
English: Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash, may frequently occur.
Danish: Lokale reaktioner på infusionsstederne: hævelse, ømhed, rødme, induration, lokal varme, kløe, blå mærker og udslæt kan hyppigt forekomme.
English: Arthralgia, back pain, pain in extremity
Danish: Artralgi, rygsmerter, smerter i ekstremiteter
English: Avoid bony prominences, or scarred areas.
Danish: Undgå steder, hvor knogler træder frem, eller arrede områder.
English: • Do not heat up or shake HyQvia.
Danish: • HyQvia må ikke varmes op eller omrystes.
English: Human normal immunoglobulin vial: Glycine, water for injections.
Danish: Hætteglas med humant normalt immunglobulin: Glycin, vand til injektionsvæsker.
English: Acute renal failure
Danish: Akut nyresvigt
English: The dose required to achieve a trough level of 6 g/l is of the order of 0.4-0.8 g/kg body weight per month.
Danish: Patienter, som ikke tidligere har fået immunglobulinbehandling For at opnå et dalniveau på 6 g/l skal dosis være i størrelsesordenen 0,4-0,8 g/kg legemsvægt pr. måned.
English: Keep the vials in the outer carton in order to protect from light.
Danish: Opbevar hætteglassene i den ydre karton for at beskytte mod lys.
English: Oedema has been reported most frequently in association with large volume subcutaneous fluid administration.
Danish: Ødemer er hyppigst rapporteret i forbindelse med subkutan administration af store mængder væske.
English: o Dispose of the sharps container using instructions provided with the container, or contact your healthcare professional.
Danish: o Bortskaf affaldsbeholderen til skarpe og spidse genstande efter de instruktioner, der fulgte med affaldsbeholderen, eller kontakt sundhedspersonalet.
English: • If instructed by your healthcare professional, attach a saline bag to the pump tubing/needle set to push the human normal immunoglobulin 10% up to the needle wings.
Danish: • Hvis sundhedspersonalet har instrueret dig i det, skal du sætte en pose med saltvand på pumpens slange eller kanylesættet for at skubbe humant normalt immunglobulin 10 % op til kanylens vinger.
English: You and your doctor will decide if you can use HyQvia at home. Do not begin treatment with HyQvia at home until you have received complete instructions.
Danish: Begynd ikke på behandling med HyQvia hjemme, før du har modtaget fuldstændige instruktioner.
English: Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Danish: Bivirkninger som kuldegysninger, hovedpine, svimmelhed, feber, opkastning, allergiske reaktioner, kvalme, artralgi, lavt blodtryk og moderate lænderygsmerter kan af og til forekomme.
English: • Insert the tip of the needle/non-vented transfer device into the center of the vial stopper and push straight downward.
Danish: • Indfør spidsen af kanylen/overførselsudstyret uden ventilering midt i hætteglassets prop, og tryk nedad i lige retning.
English: 5.0 (3.3 to 5.1)
Danish: 5,0 (3,3 til 5,1)
English: 0.1 (0.1 to 0.1)
Danish: 0,1 (0,1 til 0,1)
English: Recombinant human hyaluronidase (rHuPH20) vial 1.25, 2.5, 5, 10 or 15 ml of solution in a vial (Type I glass) with a stopper (chlorobutyl rubber).
Danish: Hætteglas med rekombinant humant hyaluronidase (rHuPH20) 1,25, 2,5, 5, 10 eller 15 ml opløsning i et hætteglas (type I-glas) med prop (chlorbutylgummi).
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering)
English: Infusion site erythema, infusion site swelling (including local swelling and oedema), infusion site pruritus (including vulvovaginal pruritus)
Danish: Erytem på infusionsstedet, hævelse på infusionsstedet (herunder lokal hævelse og ødem), pruritus på infusionsstedet (herunder vulvovaginal pruritus)
English: • Prepare to transfer the recombinant human hyaluronidase component of HyQvia by wiping each vial stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds).
Danish: • Forbered overførslen af den rekombinante humane hyaluronidasekomponent i HyQvia ved at aftørre propperne på hætteglassene med en spritserviet, hvis det er anvist, og lade dem lufttørre (i mindst 30 sekunder).
English: The effects of antibodies that bind to recombinant human hyaluronidase on human fertility are unknown.
Danish: Virkningerne af antistoffer, der bindes til rekombinant humant hyaluronidase, på human fertilitet er ikke kendte.
English: For the 1.25 mL recombinant human hyaluronidase vial size use a 18-22 gauge needle to withdraw the contents of the vial to prevent stopper push through or coring; for all other vial sizes a needle or needle-less device may be used to withdraw the contents of the vial.
Danish: Til hætteglasstørrelsen på 1,25 ml rekombinant humant hyaluronidase bruges en 18-22 gauge kanyle til at udtage indholdet fra hætteglasset for at hindre, at proppen skubbes eller udbores.
English: • Secure needle in place with sterile tape.
Danish: • Fastgør kanylen til stedet med steril tape.
English: It is supplied as a package containing one vial of human normal immunoglobulin 10% (the active substance) and one vial of recombinant human hyaluronidase (a substance which helps the human normal immunoglobulin 10% reach your blood).
Danish: Det leveres som en pakning, der indeholder et hætteglas med humant normalt immunglobulin 10 % (det aktive stof) og et hætteglas med rekombinant humant hyaluronidase (et stof, som hjælper humant normalt immunglobulin 10 % med at komme ud i blodet).
English: 10.1 (9.5 to 10.9)
Danish: 10,1 (9,5 til 10,9)
English: One ml contains: Human normal immunoglobulin.
Danish: En ml indeholder: Humant normalt immunglobulin
English: For instructions on how to use the medicinal product, see section 6.6.
Danish: For instruktioner om anvendelse af lægemidlet før administration, se pkt.
English: • Prepare to transfer the immunoglobulin 10% component of HyQvia by wiping each vial stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds).
Danish: • Forbered overførslen af komponenten immunglobulin 10 % i HyQvia ved at aftørre propperne på hætteglassene med en spritserviet, hvis det er anvist, og lade dem lufttørre (i mindst 30 sekunder).
English: The following pack sizes are available:
Danish: HyQvia fås i følgende pakningsstørrelser:
English: Infections and infestations: Meningitis aseptic
Danish: Infektioner og parasitære sygdomme: Aseptisk meningitis Immunsystemet: Overfølsomhed
English: Immunoglobulin: 100 mg/ml, at least 98% is IgG Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Danish: Immunglobulin: 100 mg/ml, mindst 98 % er IgG Maksimalt indhold af immunglobulin A (IgA): 140 mikrogram/ml.
English: Ethylenediaminetetraacetic acid (EDTA) disodium Calcium chloride
Danish: Ethylendiamintetraeddikesyre (EDTA), dinatriumsalt Calciumchlorid
English: • Push the plunger of smaller syringe to remove the air and fill the needle set up to the needle wings with the recombinant human hyaluronidase.
Danish: • Tryk på stemplet i den mindste sprøjte for at fjerne luften og fyld kanylesættet op til kanylens vinger med rekombinant humant hyaluronidase.
English: Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg.
Danish: Rekombinant humant hyaluronidase indeholder 4,03 mg natrium pr. ml med en maksimal daglig dosis på ca. 120 mg. Der skal tages højde for dette hos patienter på en natriumkontrolleret diæt.
English: The human normal immunoglobulin 10% of HyQvia and human serum albumin (an ingredient of the recombinant human hyaluronidase) are made from human plasma (the liquid part of blood).
Danish: Humant normalt immunglobulin 10 % og humant serumalbumin (et indholdsstof i rekombinant humant hyaluronidase) fremstilles af plasma fra mennesker (plasma er væsken i blodet).
English: The syringe tip will be pointing upward.
Danish: Sprøjtens spids peger nu opad.
English: Recombinant human hyaluronidase
Danish: Rekombinant humant hyaluronidase
English: Do not use vented vial access devices to remove recombinant human hyaluronidase from vials.
Danish: Brug ikke hætteglasadgangsudstyr med udluftning for at trække rekombinant humant hyaluronidase op fra hætteglassene.
English: Recombinant human hyaluronidase (rHuPH20) vial Sodium chloride
Danish: Hætteglas med rekombinant humant hyaluronidase (rHuPH20) Natriumchlorid
English: Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise)
Danish: Pyreksi, asteniske tilstande (herunder asteni, træthed, letargi, utilpashed)
English: • Slowly push the plunger of the smaller syringe with the recombinant human hyaluronidase at an initial rate per infusion site to approximately 1 to 2 ml per minute and increase as tolerated.
Danish: • Tryk langsomt på stemplet i den mindste sprøjte med det rekombinante humane hyaluronidase med en starthastighed til ca. 1 til 2 ml pr. minut for hvert infusionssted, og øg hastigheden efter, hvad du tåler.
English: Other medicines and HyQvia
Danish: Brug af anden medicin sammen med HyQvia
English: • Cap: Protective cap is on the dual vial unit.
Danish: • Låg: Der er et beskyttelseslåg på enheden med de to hætteflasker.
English: The active substance of HyQvia is human normal immunoglobulin.
Danish: Aktivt stof i HyQvia: humant normalt immunglobulin.
English: • Choose an infusion site(s) in either the middle to upper abdomen or thigh.
Danish: • Vælg infusionssted(er) i enten den midterste eller øverste del af maven eller i låret.
English: • Turn the vial upside down, with the needle/non-vented transfer device remaining in the vial.
Danish: • Vend bunden op på hætteglasset, mens kanylen/overførselsudstyret uden ventilering stadig sidder i hætteglasset.
English: Oedema (including peripheral, swelling), chills, hyperhidrosis
Danish: Ødem (herunder perifert, hævelse), kuldegysninger, hyperhidrose
English: The human normal immunoglobulin 10% is a clear and colourless or pale yellow solution.
Danish: Humant normalt immunglobulin 10 % er en klar og farveløs eller svagt gul opløsning.
English: Items include: dual vial unit(s) of HyQvia, infusion supplies (subcutaneous needle set, solution container (bag or syringe), sterile clear bandage and tape, pump tubing, transfer devices, syringes, gauze and tape), sharps container, pump, and treatment logbook and other supplies as needed.
Danish: Det er: HyQvia-enheden/-enhederne med to hætteglas, infusionsudstyr (sæt med subkutane kanyler, beholder til opløsningen (pose eller sprøjte), sterilt klart plaster og tape, slanger til pumpen, overførselsudstyr, sprøjter, gaze og tape), affaldsbeholder til skarpe og spidse genstande, pumpe, logbog over behandlingen og andet udstyr efter behov.
English: Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of -D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product.
Danish: Infusion af immunglobulinpræparater kan medføre falsk positive resultater i analyser, der afhænger af detektion af beta-D-glukaner til diagnosticering af svampeinfektioner.
English: Uncommon (≥1/1,000 to <1/100)
Danish: Ikke almindelig (≥1/1.000 til <1/100)
English: Attach the pump tubing or, the larger syringe containing human normal immunoglobulin 10% to the needle set.
Danish: Sæt pumpeslangen eller den største sprøjte med humant normalt immunglobulin 10 % på kanylesættet.
English: • Withdraw the full contents of the recombinant human hyaluronidase into the syringe.
Danish: • Træk hele indholdet af rekombinant humant hyaluronidase ind i sprøjten.
English: No chronic changes in the skin were observed in the clinical studies.
Danish: Der sås ikke kroniske hudforandringer under de kliniske studier.
English: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tremor, tachycardia, hypotension, flushing, pallor, peripheral coldness, dyspnea, paraesthesia oral, swelling face, dermatitis allergic, musculoskeletal stiffness, injection site urticaria, injection site rash, alanine aminotransferase increased.
Danish: Anafylaktisk chok, anafylaktisk/anafylaktoid reaktion, tremor, takykardi, hypotension, rødme, bleghed, perifer kuldefølelse, dyspnø, oral paræstesi, hævelser i ansigtet, allergisk dermatitis, muskuloskeletal stivhed, urticaria på injektionsstedet, udslæt på injektionsstedet, forhøjet alaninaminotransferase.
English: Human normal immunoglobulin (IG 10%) vial Glycine
Danish: Hætteglas med humant normalt immunglobulin (IG 10 %) Glycin
English: Recombinant human hyaluronidase is a clear, colourless solution.
Danish: Rekombinant humant hyaluronidase er en klar, farveløs opløsning.
English: HyQvia is a dual vial unit containing: - a solution of recombinant human hyaluronidase (Step 1 of HyQvia/Infuse first) and - a solution of human normal immunoglobulin 10% (Step 2 of HyQvia/Infuse second).
Danish: HyQvia er en enhed med to hætteglas, der indeholder: - en opløsning med rekombinant humant hyaluronidase (trin 1 i HyQvia / indgiv dette først) og - en opløsning med humant normalt immunglobulin 10 % (trin 2 i HyQvia / indgiv dette som nr. 2).
English: VIAL LABEL RECOMBINANT HUMAN HYALURONIDASE (1.25 ML)
Danish: HÆTTEGLASETIKET REKOMBINANT HUMANT HYALURONIDASE (1,25 ML)
English: The recombinant human hyaluronidase is a clear and colourless solution.
Danish: Det rekombinante humane hyaluronidase er en klar og farveløs opløsning.
English: • Remove the smaller sterile syringe from package and attach to a non-vented spike or needle (device).
Danish: • Tag den mindste sterile sprøjte ud af pakningen, og sæt den på en stift uden ventilering eller en kanyle til udtrækning.
English: Prepare the needle set with the recombinant human hyaluronidase (HY):
Danish: Klargør kanylesættet med det rekombinante humane hyaluronidase (HY):
English: HyQvia is a dual vial unit consisting of one vial of human normal immunoglobulin (Immune Globulin 10% or IG 10%) and one vial of recombinant human hyaluronidase (rHuPH20).
Danish: HyQvia er en enhed med to hætteglas: et hætteglas med humant normalt immunglobulin (immunglobulin 10 % eller IG 10 %) og et hætteglas med rekombinant humant hyaluronidase (rHuPH20).