FrancophonIA/ELRC3.0 huggingface dataset:
English: HyQvia is supplied as a pack containing: - one glass vial of recombinant human hyaluronidase, and - one glass vial of human normal immunoglobulin 10%.
Danish: HyQvia leveres som en pakning, der indeholder: - et hætteglas med rekombinant humant hyaluronidase og - et hætteglas med humant normalt immunglobulin 10 %.
English: • Check each vial of HyQvia before using:
Danish: • Kontroller hvert hætteglas med HyQvia før brug.
English: 1 vial human normal immunoglobulin 2.5 g/25 ml
Danish: 1 hætteglas med humant normalt immunglobulin 2,5 g / 25 ml
English: What HyQvia contains
Danish: HyQvia indeholder:
English: Infusion site pain (including discomfort, tenderness, groin pain)
Danish: Smerter på infusionsstedet (herunder ubehag, ømhed, lyskesmerter)
English: • Pull back on the plunger, fill the smaller syringe with air equal to the amount of recombinant human hyaluronidase in the HY vial(s).
Danish: • Træk stemplet tilbage, og fyld den mindste sprøjte med luft svarende til mængden af rekombinant humant hyaluronidase i hætteglasset/hætteglassene HY.
English: HyQvia has to be infused under the skin (subcutaneous or SC administration).
Danish: HyQvia skal gives som infusion under huden (subkutan / s.c.-indgivelse).
English: Subcutaneous use only.
Danish: Kun subkutan anvendelse.
English: Immune system disorders: Hypersensitivity General disorders and administration site conditions: Influenza-like illness, infusion site leakage
Danish: Almene symptomer og reaktioner på administrationsstedet: Influenzalignende sygdom, utæthed ved infusionsstedet
English: Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase.
Danish: Der er observeret infertilitet hos han- og hunmarsvin, der blev immuniseret for at producere antistoffer mod hyaluronidase.
English: Human normal immunoglobulin vial: 100 mg/ml, at least 98% is IgG Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Danish: Hætteglas med humant normalt immunglobulin: 100 mg/ml, mindst 98 % er IgG Maksimalt indhold af immunglobulin A (IgA): 140 mikrogram/ml.
English: If you have any questions, talk to your doctor or nurse.
Danish: Tal med din læge eller sygeplejerske, hvis du har spørgsmål.
English: 1 vial recombinant human hyaluronidase 1.25 ml
Danish: 1 hætteglas med rekombinant humant hyaluronidase 1,25 ml
English: Infuse 2
Danish: Infunderes som nr. 2.
English: • Remove the cap of needle/non-vented transfer device.
Danish: • Fjern låget fra kanylen/overførselsudstyret uden ventilering.
English: • Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).
Danish: • Hypogammaglobulinæmi hos patienter før eller efter allogen hæmatopoietisk stamcelletransplantation.
English: Very common side effects (may affect more than 1 in 10 infusions):
Danish: Meget almindelige bivirkninger (kan forekomme ved mere end 1 ud af 10 infusioner): Smerter på infusionsstedet, herunder let til moderat ubehag og ømhed.
English: HyQvia administration scheme Recombinant human hyaluronidase
Danish: Oversigt over administration af HyQvia Rekombinant humant hyaluronidase
English: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IV and SC administration of immunoglobulin products.
Danish: Tromboemboliske reaktioner som myokardieinfarkt, slagtilfælde, lungeemboli og dyb venetrombose er set i sjældne tilfælde med i.v.
English: The effects of long-term use of recombinant human hyaluronidase on pregnancy, breast-feeding and fertility are currently not known.
Danish: Langtidsvirkningen på graviditet, amning og frugtbarhed ved brug af rekombinant humant hyaluronidase er ukendt på nuværende tidspunkt.
English: Headache, tiredness, nausea, vomiting, diarrhoea, abdominal pain, muscle or joint pain, chest pain, fever, feeling weak or unwell.
Danish: Hovedpine, træthed, kvalme, opkastning, diarré, mavesmerter, muskel- eller ledsmerter, brystsmerter, feber, svaghedsfølelse eller utilpashed.
English: • Remove the needle cover.
Danish: • Fjern kanylehætten.
English: Typical signs or symptoms include: feeling light-headed, dizzy or faint, skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing, abnormal heart rate, chest pain, blueness of lips or fingers and toes, blurred vision.
Danish: Typiske tegn eller symptomer omfatter: en følelse af svimmelhed, ørhed eller svaghed, hududslæt og kløe, hævelse i mund eller hals, åndedrætsbesvær, hvæsende åndedræt, unormal hjerterytme, smerter i brystregionen, blå læber eller fingre og tæer, sløret syn.
English: Thromboembolism
Danish: Tromboemboli
English: Paresthesia
Danish: Paræstesi
English: Do not use heating devices including microwaves.
Danish: Brug ikke apparater til opvarmning,
English: If you use more HyQvia than you should
Danish: Hvis du har brugt for meget HyQvia
English: Transmissible agents
Danish: Overførbare stoffer
English: This vial contains recombinant human hyaluronidase.
Danish: Dette hætteglas indeholder rekombinant humant hyaluronidase.
English: Infuse first the recombinant human hyaluronidase.
Danish: Infunder rekombinant humant hyaluronidase først.
English: How to use HyQvia
Danish: Sådan skal du bruge HyQvia
English: Prepare human normal immunoglobulin 10% vial:
Danish: Forbered hætteglasset med humant normalt immunglobulin 10 %:
English: Infusion site discoloration, infusion site bruising (including hematoma, haemorrhage), infusion site mass (including nodule), infusion site warmth, infusion site induration, gravitational oedema/genital swelling b (including genital oedema, scrotal and, vulvovaginal swelling)
Danish: Lokale reaktioner (i alt): Misfarvning på infusionsstedet, blå mærker på infusionsstedet (herunder hæmatom, hæmoragi), fortykkelse på infusionsstedet (herunder knude), varme på infusionsstedet, induration på infusionsstedet, gravitationelt ødem/genital hævelse (herunder genitalt ødem, skrotal og vulvovaginal hævelse)
English: Despite these measures, when medicines prepared from human blood or plasma are used, the possibility of passing on infection cannot be totally excluded.
Danish: På trods af disse forholdsregler kan risikoen for overførsel af infektion ikke helt udelukkes, når der anvendes præparater fremstillet af humant blod eller plasma.
English: After opening, dispose of any unused solutions in the vials.
Danish: Bortskaf eventuel ikke anvendt opløsning i hætteglassene efter åbning.
English: VIAL LABEL HUMAN NORMAL IMMUNOGLOBULIN (2.5 G)
Danish: HÆTTEGLASETIKET HUMANT NORMALT IMMUNGLOBULIN (2,5 G)
English: Pack size: One vial of IG 10% and one vial of recombinant human hyaluronidase in a dual vial unit.
Danish: Et hætteglas med IG 10 % og et hætteglas med rekombinant humant hyaluronidase i en enhed med to hætteglas.
English: Administer the recombinant human hyaluronidase infusion first:
Danish: Indgiv det rekombinante humane hyaluronidase først:
English: Insert the spike of the vented pump tubing or spike and venting needle into human normal immunoglobulin 10% vial(s).
Danish: Indfør stiften i pumpeslangen med ventilering eller stift og ventileringsnål i hætteglasset (hætteglassene) med humant normalt immunglobulin 10 %.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Danish: På trods heraf kan muligheden for overførsel af smitstoffer ikke helt udelukkes, når der administreres lægemidler fremstillet af humant blod eller plasma.
English: Frequency of Adverse Reactions (ADRs) with HyQvia
Danish: Hyppigheden af bivirkninger med HyQvia
English: Infuse 1
Danish: Infunderes som nr 1.
English: The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by IG 10%, as described below.
Danish: Hele indholdet af hætteglasset med rekombinant humant hyaluronidase skal indgives, uanset om hele indholdet af hætteglasset med IG 10 % indgives eller ej. Lægemidlets to komponenter skal indgives efter hinanden gennem den samme kanyle, idet det rekombinante humane hyaluronidase indgives først, efterfulgt af IG 10 %, som beskrevet nedenfor.
English: - feeling light-headed, dizzy or faint, - skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing, - abnormal heart rate, chest pain, blueness of lips or fingers and toes, - blurred vision.
Danish: - en følelse af svimmelhed, ørhed eller svaghed, - hududslæt og kløe, hævelse i mund eller hals, åndedrætsbesvær, hvæsende åndedræt, - unormal hjerterytme, smerter i brystregionen, blå læber eller fingre og tæer, - sløret syn.
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin SC use only.
Danish: HyQvia 100 mg/ml infusionsvæske til subkutan anvendelse humant normalt immunglobulin Kun s.c. anvendelse
English: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Danish: HyQvia 100 mg/ml infusionsvæske, opløsning til subkutan anvendelse
English: Hypersensitivity, influenza-like illness, and infusion site leakage, inflammation of the layers lining the brain (aseptic meningitis).
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): Overfølsomhed, influenzalignende sygdom og utæthed ved infusionsstedet, betændelse i hjernehinden (aseptisk meningitis).
English: Dosing
Danish: Amning
English: Recombinant human hyaluronidase vial: human hyaluronidase.
Danish: Hætteglas med rekombinant humant hyaluronidase: humant hyaluronidase.
English: • Throw away the needle(s) into the sharps container.
Danish: • Smid kanylen (kanylerne) ud i affaldsbeholderen til skarpe og spidse genstande.
English: Any long-term inflammation, lumps (nodules) or inflammation that occur at the infusion site and last more than a few days should be reported to your physician.
Danish: Informer din læge om alle tilfælde af langvarig inflammation, små knuder eller inflammation, der opstår på infusionsstedet og varer mere end nogle få dage.
English: • Allow vials to reach room temperature.
Danish: • Lad hætteglassene nå stuetemperatur.
English: Aseptic meningitis syndrome has been reported to occur in association with intravenous and subcutaneous immunoglobulin treatment; the symptoms usually begin within several hours to 2 days following immunoglobulin treatment.
Danish: Aseptisk meningitissyndrom er blevet rapporteret at forekomme i forbindelse med intravenøs og subkutan behandling med immunglobulin.
English: • Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml.
Danish: Det samlede natriumindhold i rekombinant humant hyaluronidase er 4,03 mg/ml.
English: Hypersensitivity to recombinant human hyaluronidase
Danish: Overfølsomhed over for rekombinant humant hyaluronidase
English: Prepare recombinant human hyaluronidase vial (HY):
Danish: Klargør hætteglasset med rekombinant humant hyaluronidase (HY):
English: Solution for infusion for subcutaneous use
Danish: Infusionsvæske, opløsning til subkutan anvendelse
English: Chills,migraine, increasedblood pressure, dizziness, abdominal bloating, skin rash/allergic rash/redness, itching, pain in chest, arms and/or legs, genital swelling (resulting from spread of swelling from the infusion site), swelling of the legs, feet and ankles, positive blood tests for antibodies.
Danish: Ikke almindelige bivirkninger (kan forekomme ved op til 1 ud af 100 infusioner): Kuldegysninger, migræne, forhøjet blodtryk, svimmelhed, oppustet mave, hududslæt/allergisk udslæt/rødme, kløe, smerter i bryst, arme og/eller ben, hævelse omkring kønsorganerne (som følge af, at hævelsen har spredt sig fra infusionsstedet), hævelse i ben, fødder og ankler, antistoffer i blodprøver.
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin
Danish: HyQvia 100 mg/ml infusionsvæske til subkutan anvendelse humant normalt immunglobulin
English: Insert the needle:
Danish: Indfør kanylen:
English: • Attach the syringe filled with recombinant human hyaluronidase to the needle set
Danish: • Sæt sprøjten med det rekombinante humane hyaluronidase på kanylesættet
English: Sodium phosphate dibasic Human albumin
Danish: Natriumfosfat, dibasisk
English: Immunogenicity of recombinant human hyaluronidase
Danish: Rekombinant humant hyaluronidases immunogenicitet
English: Although these side effects have so far not been seen with HyQvia, it is possible that someone using HyQvia may get them: Trembling, oral tingling, fast heart beat, allergic reactions, flushing or pallor, coldness of hand or feet, shortness of breath, swelling of face,excessive sweating, muscle stiffness,change in liver function blood tests (alanine aminotransferase increased).
Danish: Rysten, snurren i munden, hurtigt hjerteslag, allergiske reaktioner, rødme eller bleghed, kolde hænder eller fødder, stakåndethed, hævelse i ansigtet, overdreven sveden, muskelstivhed, ændringer i blodprøver til test af leverfunktion (forhøjet alaninaminotransferase).
English: Open HyQvia dual vial unit(s):
Danish: Åbn HyQvia-enheden/-erne med de to hætteglas:
English: Human normal immunoglobulin
Danish: Humant normalt immunglobulin
English: Migraine dizziness
Danish: Migræne, svimmelhed
English: What HyQvia is and what it is used for What you need to know before you use HyQvia How to use HyQvia
Danish: Det skal du vide, før du begynder at bruge HyQvia Sådan skal du bruge HyQvia Bivirkninger
English: Remove needle set:
Danish: Fjern kanylesættet:
English: Reactions at the infusion site: These include redness, swelling, itching, hardening, and rash at the site of infusion.
Danish: Almindelige bivirkninger (kan forekomme ved op til 1 ud af 10 infusioner): Reaktioner på infusionsstedet: Disse omfatter rødme, hævelse, kløe, hårdhed og udslæt på infusionsstedet.
English: Infusion for subcutaneous use.
Danish: Infusionsvæske til s.c. anvendelse.
English: How HyQvia works
Danish: Hvordan virker HyQvia?
English: MA (EU) Number
Danish: MA (EU) Nummer
English: (Invented) name
Danish: (Særnavn) navn
English: Do not refreeze.
Danish: Må ikke nedfryses igen.
English: 10-15 cm 2.0 - 2.5 bar
Danish: 10 cm-15 cm 2,0 bar-2,5 bar
English: After the Commission Decision the National Competent Authorities will update the product information as required.
Danish: Efter Kommissionens afgørelse skal de nationale kompetente myndigheder ajourføre produktoplysningerne i overensstemmelse hermed.
English: Recommended distance from target tissue
Danish: Anbefalet afstand fra målvæv
English: Do not use solutions that are cloudy or have deposits.”
Danish: Anvend ikke opløsninger, der er uklare eller har aflejringer.”
English: The solution should be clear or slightly opalescent.
Danish: Opløsningen skal være klar eller let opaliserende.
English: 6 cm Yellow Flexible Tip
Danish: 6 cm gul, fleksibel spids
English: Quixil forms a clear film over the area of application.
Danish: Quixil danner en gennemsigtig film over applikationsområdet.
English: Omrix Pressure Regulator
Danish: Omrix trykregulator
English: Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Danish: Bemærk: Disse ændringer til produktresuméet og indlægssedlen er gyldige på tidspunktet for Kommissionens afgørelse.
English: When BAC and Thrombin have been drawn up into the administration device they must be used immediately.”
Danish: Når BAC og trombin er blevet opsuget i applikatoren, skal de anvendes straks.”
English: The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6).
Danish: Produktet må kun rekonstitueres og administreres i henhold til instruktionerne og med de anordninger, der anbefales til dette produkt (se pkt.
English: Recommended spray pressure
Danish: Anbefalet spray-tryk
English: • Handling
Danish: • Håndtering
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer, der skal inkluderes i de relevante punkter i produktresumeet og på indlægssedlen
English: After thawing, unopened vials can be stored at 2 - 8C and protected from light, for up to 30 days.
Danish: Efter optøning kan uåbnede hætteglas opbevares ved 2 °C-8 ºC og beskyttet mod lys i op til 30 dage.
English: The following contra-indication should be added at the end of the section:
Danish: Den følgende kontraindikation skal tilføjes til sidst i punktet:
English: “Quixil should only be used by experienced surgeons.
Danish: ”Quixil må kun anvendes af erfarne kirurger.
English: Prior to applying Quixil the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Danish: Forud for påføring af Quixil skal sårets overfladeareal tørres ved brug af standardteknikker (f.eks. intermitterende applikation af kompresser, vatpinde, brug af sugeanordninger).
English: The following text should be added at the end of the section:
Danish: Den følgende tekst skal tilføjes til sidst i punktet:
English: The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Danish: Produktet skal derefter sprayes på vævsoverfladen med korte stød (0,1 ml-0,2 ml), så der dannes et tyndt, jævnt lag.
English: BEFORE YOU ARE TREATED WITH QUIXIL You must not be treated with Quixil:
Danish: DET SKAL DU VIDE, FØR DU BLIVER BEHANDLET MED QUIXIL Brug ikke Quixil
English: The entire section should read as follows, in bold and underlined format where indicated: “To avoid the risk of life threatening gas or air embolism, Quixil should only be sprayed using pressurised CO2
Danish: Hele punktet skal lyde som følger, i fremhævet og understreget format, hvor indikeret: ”For at undgå risikoen for livstruende gas- eller luftemboli, må Quixil kun sprayes på ved hjælp af CO2 under tryk.
English: The text should read as follows: “Store at  -18C.
Danish: ”Opbevares ved  -18C.
English: Should be replaced with the following text, in bold and underlined format where indicated
Danish: Skal erstattes med den følgende tekst, i fremhævet og understreget format, hvor angivet
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue.”
Danish: 4.4 og 6.6 for påføring med spray for specifikke anbefalinger vedrørende det påkrævede tryk og afstanden fra vævet.”
English: • “Spray application of Quixil should not be used in endoscopic procedures.”
Danish: • ”Applikation af Quixil med spray må ikke anvendes ved endoskopiske indgreb.”
English: Pressure regulatory to be used
Danish: Trykregulering, der skal anvendes
English: Should be replaced with the following text, in bold and underlined format:
Danish: Skal erstattes med den følgende tekst, i fremhævet og understreget format:
English: Quixil spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer - do not spray closer than the recommended distance.
Danish: Påføring af Quixil med spray må kun anvendes, hvis det er muligt nøjagtigt at bedømme spray-afstanden som anbefalet af producenten - der må ikke sprayes tættere på end den anbefalede afstand.
English: Quixil Applicator Device
Danish: Quixil applikatoranordning
English: Spray devices and the accessory tip provide instructions for use with recommendations for pressure ranges and to the spraying distance from the tissue surface.
Danish: Spray-anordninger og tilbehørsspidsen har brugsanvisninger med anbefalinger til trykområder og til spray-afstand fra vævsoverfladen.
English: In open wound surgery - for spray application of Quixil, a pressure regulator device that delivers a maximum pressure of no more than 2.5 bar and uses carbon dioxide gas only should be used.
Danish: Ved indgreb i åbne sår - påføring af Quixil med spray må kun foretages med en trykregulatorenhed med et maksimalt tryk på højst 2,5 bar, og som kun anvender kuldioxidgas.
English: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.
Danish: ”Quixil må kun anvendes af erfarne kirurger, der er blevet uddannet i brugen af QUIXIL.
English: Open surgery
Danish: Åben kirurgi
English: • „Quixil should not be used in endoscopic surgery or for keyhole surgery.“
Danish: • ”Quixil må ikke anvendes ved endoskopisk kirurgi eller ved nøglehulskirurgi.”
English: This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Danish: Denne forekomst synes at være relateret til brugen af spray-anordningen ved højere end anbefalede tryk og/eller i umiddelbar nærhed af vævsoverfladen.
English: The following changes should be made to the package leaflet of Quixil:
Danish: Der skal foretages følgende ændringer i indlægssedlen til Quixil:
English: In the absence of a specific recommendation Quixil should not be sprayed closer than 10-15 cm from the tissue surface.
Danish: Ved manglende specifik anbefaling må Quixil ikke sprayes tættere på end 10 cm-15 cm fra vævsoverfladen.
English: 4.8 Undesirable effects The following text should be added at the end of the section, before the last sentence, as shown below:
Danish: Den følgende tekst skal tilføjes sidst i punktet, før den sidste sætning, som vist nedenfor:
English: To avoid the risk of potentially life threatening air embolism your surgeon is recommended to spray Quixil using pressurised CO2 only.
Danish: For at undgå risiko for potentielt livstruende luftemboli, anbefales det, at kirurgen kun sprayer Quixil ved hjælp af CO2 under tryk.
English: 4.2 Posology and method of administration The following text should be added to this section: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.“ 4.2.2 Method and Route of Administration
Danish: Teksten i dette punkt skal lyde som følger: ”Quixil må kun anvendes af erfarne kirurger, der er blevet uddannet i brugen af QUIXIL.” 4.2.2 Anvendelsesmåde og administrationsvej Teksten i dette punkt skal lyde som følger: ”Til epilæsional brug.”
English: Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Danish: Forbind den korte slange på applikatoren til den ende af den lange luftslange med hanluerlock.
English: HOW QUIXIL IS USED
Danish: SÅDAN BRUGES QUIXIL
English: In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the tissue surface.
Danish: Ved manglende specifik anbefaling må der ikke sprayes tættere på end 10 cm-15 cm fra vævsoverfladen.
English: The following changes should be made to the SmPC of Quixil:
Danish: Der skal foretages følgende ændringer i produktresuméet til Quixil:
English: To avoid the risk of potentially life threatening air embolism Quixil should be sprayed using pressurised CO2 gas only.
Danish: For at undgå risikoen for potentiel livstruende luftemboli, må Quixil kun påsprøjtes ved brug af CO2-gas.
English: Spray set to be used
Danish: Operation Spray-sæt, der skal anvendes
English: Connect the female luer lock of the gas tube (with the bacteriostatic filter) to a pressure regulator The pressure regulator should be used in accordance with the manufacturer's instructions.
Danish: Tilslut gasslangens hun-luerlock (med det bakteriostatiske filter) til en trykregulator.
English: When using accessory tips with this product, be sure to follow carefully the instructions for use.”
Danish: Når der anvendes tilbehørsspidser med dette produkt, skal man sørge for, at brugsanvisningen følges nøje.”
English: When using an accessory tip with this product, be sure to follow carefully the instructions for use.”
Danish: Når der anvendes en tilbehørsspids med dette produkt, skal man sørge for, at brugsanvisningen følges nøje.”