FrancophonIA/ELRC3.0 huggingface dataset:
English: No treatment failures occurred during the 6month study period.
Danish: Der opstod ingen behandlingssvigt i løbet af studieperioden på 6 måneder.
English: The mean anti-HBs serum level before switching was 393 ± 139 IU/l.
Danish: Det gennemsnitlige anti-HBs-serumniveau før skift var 393±139 IE/l.
English: This can be an allergic reaction or a serious allergic reaction (anaphylactic shock).
Danish: Dette kan være tegn på en allergisk reaktion eller en alvorlig allergisk reaktion (anafylaktisk shock).
English: Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.
Danish: Immunglobuliner er en normal bestanddel af menneskets krop, og derfor er test af toksiciteten hos heterologe arter irrelevant.
English: The effects were grouped by system organ classes under relevant medical headings.
Danish: Bivirkningerne grupperes efter systemorganklasse med relevante medicinske overskrifter.
English: - Take the syringe out of the pack.
Danish: - Tag sprøjten ud af pakken.
English: The following adverse reactions have been reported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study (PASS).
Danish: Følgende bivirkninger er blevet rapporteret i forbindelse med 4.810 subkutane anvendelser af Zutectra i løbet af fire afsluttede kliniske studier og 1.006 anvendelser i et ikke-interventionsstudie af sikkerheden efter markedsføring (post marketing safety study, PASS).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du bruger dette lægemiddel.
English: Patients were to be treated with Zutectra in accordance with the information and dosage given in the SPC.
Danish: Patienterne skulle behandles med Zutectra i overensstemmelse med de oplysninger og den dosering, som gives i produktresuméet.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Det gælder også for ukendte eller nye virusser eller andre slags infektioner.
English: You may be allergic to immunoglobulins (antibodies) without knowing it, even if you have tolerated previous treatments with human immunoglobulins.
Danish: Du kan være allergisk over for immunglobuliner (antistoffer) uden at vide det, selvom du har kunnet tåle tidligere behandling med humane immunglobuliner.
English: Zutectra contains a small quantity of IgA.
Danish: Zutectra indeholder en mindre mængde IgA.
English: This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.
Danish: Denne anbefaling gælder også for dokumentation i behandlingsdagbogen fra patientens egen administration af lægemidlet i eget hjem.
English: Zutectra is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days.
Danish: Zutectra absorberes langsomt i modtagerens kredsløb og når sit maksimum med en forsinkelse på 27 dage.
English: Water for injections
Danish: Vand til injektion
English: Talk to the doctor or healthcare professional about these or any other unusual conditions you may find.
Danish: Tal med lægen eller sundhedspersonalet om det eller om andre usædvanlige forhold, som du oplever.
English: This will help the skin stay supple and help the medicine be absorbed evenly.
Danish: På den måde vil huden blive ved med at være smidig, og det hjælper med til, at medicinen optages jævnt.
English: Avoid using the belt line area, as rubbing may irritate the injection site.
Danish: Undgå at bruge bælteområdet, da gnidning kan irritere injektionsområdet.
English: Antibody levels >100 IU/l should be maintained.
Danish: Antistofniveau >100 IE/l bør opretholdes.
English: Your doctor will regularly check your condition and tell you how much and how often you need to use Zutectra.
Danish: Din læge vil regelmæssigt kontrollere din tilstand og fortælle dig, hvor meget og hvor ofte du behøver at bruge Zutectra.
English: Potential complications can often be avoided by ensuring that patients: are not sensitive to human normal immunoglobulin, by initially injecting the product slowly; are carefully monitored for any symptoms throughout the injection.
Danish: De potentielle komplikationer kan ofte undgås ved at sikre, at patienter: ikke er sensitive for humant normalt immunglobulin ved indledningsvist at injicere præparatet langsomt; monitoreres nøje for symptomer under hele injektionen.
English: No fatal case was observed during the study.
Danish: Ingen dødelige tilfælde blev observeret i løbet af studiet.
English: Allow yourself enough time to inject the whole of the solution until the syringe is empty.
Danish: Giv dig god tid til at indsprøjte hele opløsningen, indtil sprøjten er tom.
English: Patients must be monitored for serum anti-HBs antibody levels regularly.
Danish: Patienterne skal monitoreres jævnligt for serum-anti-HBs-antistof.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder endvidere for ukendte eller nye vira og andre patogener.
English: If the solution is discoloured, cloudy or contains particles, discard it and start again with a new syringe.
Danish: Hvis opløsningen er misfarvet, grumset eller indeholder partikler, skal du kassere den og begynde forfra med en ny sprøjte.
English: Information on the starting material of Zutectra and the possibility of transmission of infectious agents:
Danish: Oplysninger om startmateriale for fremstilling af Zutectra og muligheden for at overføre stoffer, som kan medføre infektion:
English: Do not use this medicine after the expiry date which is stated on the outer carton and the syringe label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp.
English: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA content ≤ 6,000 micrograms/ml
Danish: : 59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4
English: (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The following side effects have been reported with Zutectra:
Danish: Der er rapporteret følgende bivirkninger med Zutectra:
English: Ensure that Zutectra is not administered into a blood vessel, because of the risk of shock.
Danish: Det skal sikres, at Zutectra ikke administreres i et blodklar på grund af risikoen for shock.
English: Fatigue, tiredness
Danish: Udmattelse, træthed
English: The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below.
Danish: Bivirkningerne i de fire studier opsummeres og kategoriseres i henhold til MedDRAsystemorganklasse og hyppighed nedenfor.
English: If you have an allergic reaction to Zutectra, the injection will be stopped immediately.
Danish: Hvis du får en allergisk reaktion på grund af Zutectra, standses injektionen straks.
English: You may have to wait at least 3 months after the last injection of Zutectra before you can have live attenuated vaccines.
Danish: Du er måske nødt til at vente mindst 3 måneder efter sidste injektion af Zutectra, inden du kan få levende, svækkede vacciner.
English: Using the Clopper Pearson method, the failure rate after 18 weeks was 0 % for patients of the ITT set (95 % CI: [0, 14.8 %]).
Danish: Ved brug af Clopper Pearson-metoden var fejlprocenten efter 18 uger på 0 % for patienter i ITT-sættet (95 % CI: [0; 14,8 %]).
English: You will be carefully observed during and shortly after the 1st injection with Zutectra to make sure that you do not suffer from a reaction.
Danish: Du bliver observeret nøje under og kort efter første injektion med Zutectra for at sikre, at du ikke får en reaktion.
English: This medicine must not be mixed with other medicines.
Danish: Medicinen må ikke blandes med anden medicin.
English: You should inject Zutectra into the fatty layer between the skin and muscle (about 8 to 12 mm under the skin).
Danish: Du skal foretage injektionen i et fedtlag mellem huden og musklen (ca. 8-12 mm under huden).
English: Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection.
Danish: Forsøg ikke at foretage injektionen af Zutectra, før du er sikker på, at du forstår, hvordan du skal klargøre injektionsopløsningen og selv foretage injektionen.
English: However, if you have used more than the prescribed dose of Zutectra, contact your doctor, healthcare professional or pharmacist straight away for advice.
Danish: Hvis du imidlertid har brugt mere end den ordinerede dosis af Zutectra, skal du straks kontakte lægen, sundhedspersonalet eller apoteket for at få vejledning.
English: The maximum IgA content is 6,000 micrograms/ml.
Danish: Det maksimale IgA-indhold er 6.000 mikrogram/ml.
English: Zutectra must not be administered intravascularly.
Danish: Zutectra må ikke administreres intravaskulært.
English: The physician must therefore weigh the benefit of treatment with Zutectra against the potential risk of hypersensitivity reactions.
Danish: Lægen skal derfor afveje fordelene ved behandling med Zutectra i forhold til den potentielle risiko for overfølsomhedsreaktioner.
English: The other ingredients are glycine and water for injections.
Danish: Øvrige indholdsstoffer: glycin og vand til injektionsvæsker.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women.
Danish: Lægemidlets sikkerhed ved brug i forbindelse med graviditet hos mennesker er ikke fastlagt i kontrollerede kliniske studier og må derfor kun gives med forsigtighed til gravide kvinder.
English: These include - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of virus/infections.
Danish: De omfatter: - omhyggelig udvælgelse af blod- og plasmadonorer for at sikre, at potentielle smittebærere udelukkes, og - test af hver donation og pulje med plasma for tegn på virus/infektion.
English: Pack size of five syringes in a blistered pack.
Danish: Pakningsstørrelse på fem sprøjter i en blisterpakning.
English: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Danish: Efter injektion af immunglobulin kan en forbigående stigning i forskellige passivt overførte antistoffer i patientens blod forårsage vildledende positive resultater af serologiske analyser.
English: Please tell your doctor or healthcare professional prior to treatment if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood.
Danish: Fortæl det til lægen eller sundhedspersonalet inden behandling hvis du har fået at vide, at du har antistoffer mod immunglobulin af typen IgA i blodet.
English: Your doctor will be able to explain this to you.
Danish: Din læge kan forklare dig hvorfor.
English: Keep the container in the outer carton in order to protect from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: No hepatitis B reinfection was reported and no patient was tested HBsAg positive during the treatment period of 48 weeks.
Danish: Der blev ikke rapporteret hepatitis B-reinfektion, og ingen patienter blev testet HBsAg-positive i løbet af behandlingsperioden på 48 uger.
English: Thighs: Use middle and outer areas where you can pinch up tissue.
Danish: Lår: Brug de midterste og yderste områder, hvor du kan klemme væv sammen.
English: Frequency per injection has been evaluated using the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Danish: Hyppigheden pr. injektion er evalueret ud fra følgende kriterier: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Injection into a vein or a blood vessel may result in allergic shock.
Danish: Injektion i en vene eller blodkar kan medføre allergisk shock.
English: No other preparations may be added to the Zutectra solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.
Danish: Intet andet præparat må tilføres Zutectra-injektionsvæsken, idet enhver ændring i elektrolytkoncentration eller pH kan føre til præcipitation eller denaturering af proteiner.
English: Gently pinch the skin together around the disinfected injection site (to raise it up a little) and push the needle into the skin with a rapid, confident movement at an angle of 45 to 90 degrees.
Danish: Knib forsigtigt huden sammen omkring injektionsstedet (løft huden lidt op), og tryk kanylen ind med en hurtig og fast bevægelse i en vinkel på 45 til 90 grader.
English: INFORMATION IN BRAILLE Zutectra 500 IU
Danish: INFORMATION I BRAILLESKRIFT Zutectra 500 IE
English: Passive transmission of antibodies to erythrocyte 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 erytrocytantigener, f.eks. A, B, D, kan interferere med visse serologiske analyser for antistoffer mod røde blodlegemer, f.eks. den direkte antiglobulintest (DAT, Coombs' direkte test).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER
English: Make sure you use Zutectra as prescribed and as instructed by your doctor to avoid the risk of a hepatitis B re-infection.
Danish: Sørg for at tage Zutectra som angivet, og som din læge ordinerer for at undgå risiko for reinfektion med hepatitis B.
English: Zutectra can reduce the effectiveness of some vaccines (measles, rubella, mumps, chicken pox) for a period of up to 3 months.
Danish: Zutectra kan reducere effekten af visse vacciner (mod mæslinger, røde hunde, fåresyge, skoldkopper) i en periode på op til 3 måneder.
English: Store and transport refrigerated (2°C-8°C).
Danish: Opbevares i køleskab og transporteres nedkølet (2°C-8°C).
English: Glycine
Danish: Glycin
English: The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events.
Danish: Patienten eller plejeren får anvisninger i injektionsteknik, i at føre en behandlingsdagbog og forholdsregler i tilfælde af alvorlige bivirkninger.
English: The contents of one syringe are intended for use once only.
Danish: Indholdet i en sprøjte er beregnet til engangsbrug.
English: Zutectra contains 150 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG).
Danish: Zutectra indeholder 150 mg/ml humant plasmaprotein, hvoraf mindst 96 % er immunglobulin G (IgG).
English: Zutectra must be brought to room temperature (approx. 23°C-27°C) before use.
Danish: Zutectra skal have stuetemperatur (ca. 23 °C-27 °C) inden anvendelsen.
English: Please note that alcohol swabs and needles are not contained in the pack and you need to supply them yourself.
Danish: Vær opmærksom på, at sprittamponer og kanyler ikke medfølger i pakken, så du skal selv sørge for dem.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Biotest Pharma GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Biotest Pharma GmbH
English: It is strongly recommended that every time that Zutectra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales kraftigt, at man ved hver indgivelse af Zutectra til en patient registrerer navnet og batchnummeret på lægemidlet, så forbindelsen mellem patienten og lægemidlets batch altid kan spores.
English: For safety information with respect to transmissible agents, see section 4.4.
Danish: For sikkerhedsinformation vedrørende agenser, der kan overføres, se pkt.
English: Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
Danish: Antistofniveau > 100 IE/l bør opretholdes hos HBsAg- og HBV-DNA-negative patienter.
English: Precautions to be taken before handling or administering the medicinal product Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet For at patienten selv eller plejeren kan indsprøjte lægemidlet i sit hjem skal vedkommende være undervist af en læge med erfaring i vejledning af patienter til behandling i hjemmet.
English: Particularly if you do not have enough immunoglobulins of the type IgA in your blood, allergic reactions such as a sudden fall in blood pressure or shock may occur.
Danish: Det gælder især, hvis du ikke har nok immunglobulin af typen IgA i blodet, at der kan opstå allergiske reaktioner såsom pludseligt fald i blodtrykket eller chok.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs.
Danish: Især patienter, som er naive med hensyn til humant, normalt immunglobulin, patienter, der skifter fra et andet præparat, eller hvis der har været et langt interval siden den sidste injektion, skal overvåges i løbet af den første injektion og i den første time efter den første injektion, for at detektere mulige uønskede tegn.
English: In very rare cases human normal immunoglobulins may cause a serious allergic reaction.
Danish: I meget sjældne tilfælde kan humane normale immunglobuliner forårsage en alvorlig allergisk reaktion.
English: The maximum immunoglobulin A (IgA) content is 6,000 micrograms/ml.
Danish: Det maksimale indhold af immunglobulin A (IgA) er 6.000 mikrogram/ml.
English: Important: Do not use on any area where you can feel lumps, bumps, firm knots, pain or on an area that is discoloured, indented, scabbed, or where the skin is broken.
Danish: Vigtigt: Brug ikke et område, hvor du kan føle knuder, buler, faste knuder, smerte eller på et sted, som er misfarvet, indtrykket, med sårskorpe, eller hvor huden er ødelagt.
English: Abdomen (stomach): Do not use the area within one inch around the navel.
Danish: Maven: Brug ikke området inden for ca. 2,5 cm omkring navlen.
English: No serious adverse events were reported to be related to study medication.
Danish: Der blev ikke rapporteret alvorlige bivirkninger relateret til studielægemidlet.
English: Wipe the intended area with an alcohol swab.
Danish: Tør det tiltænkte område af med en sprittampon.
English: Do not use Zutectra - if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for humant immunglobulin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: It is much easier for someone else to use this site if you do need help.
Danish: Det er meget nemmere for en anden person at bruge din arm som injektionssted, hvis du har brug for hjælp.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Your doctor will tell you how much and how often you need to use Zutectra.
Danish: Din læge kan fortælle dig, hvor meget og hvor ofte du skal tage Zutectra.
English: Zutectra contains antibodies against the hepatitis B virus which are the body's own defensive substances to protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.
Danish: Zutectra indeholder antistoffer mod hepatitis B-virus, som er kroppens egen forsvarsmekanisme for at beskytte dig mod hepatitis B. Hepatitis B er en leverbetændelse forårsaget af hepatitis B-virus.
English: 6.6 Special precautions for disposal and other handling This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Dette lægemiddel skal opnå stuetemperatur (ca. 23°C-27°C) inden brug.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: De trufne forholdsregler kan have en begrænset værdi i forhold til ikke-kappebærende virusser såsom parvovirus B19.
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: Ifølge klinisk erfaring med immunglobulin forventes der ingen skadelig virkning på graviditetens forløb eller fostret eller nyfødte.
English: No serious adverse reaction was reported.
Danish: Der blev ikke rapporteret alvorlige bivirkninger.
English: If you forget to use Zutectra
Danish: Hvis du har glemt at bruge Zutectra
English: A sufficient surveillance period with stable anti-HBs trough serum levels of > 100 IU/l as well as a fixed dosage regimen is required: the monitoring schedule of patients anti-HBs antibody levels (see above) needs to be closely followed.
Danish: Det er nødvendigt med en tilstrækkelig overvågningsperiode med stabile dalværdier af anti-HBs-serumniveauet på > 100 IE/l, og at der følges et fast doseringsregime: monitoreringsplanen for patientens anti-HBs-antistofniveau (se ovenfor) skal følges nøje.
English: Try standing in front of a mirror to locate the site or you may want to ask your caregiver to give you the injection.
Danish: Prøv at stå foran et spejl for at finde et sted, eller bed din plejer om at foretage injektionen.
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: Almindelige forholdsregler for at forhindre infektion som følge af brug af lægemidler fremstillet af humant blod eller plasma omfatter udvælgelse af donorer, screening af enkelte donationer og plasmapuljer for bestemte infektionsmarkører samt en effektiv produktionsmetode til at inaktivere/fjerne vira.
English: You are likely to have more fatty tissue the closer you are to the hip and the further you are from the knee.
Danish: Du vil formentlig have mere fedtvæv tættest på hoften og længst væk fra knæene.
English: During the 48-weeks treatment phase constant serum HBs antibody concentrations ≥ 100 IU/l were measured in all patients at all assessments with mean values of 312.0 ± 103.5 IU/l at the end of the treatment period.
Danish: I løbet af behandlingsfasens 48 uger blev der målt konstante serum-HBs-antistofkoncentrationer ≥ 100 IE/l hos alle patienter ved alle evalueringer, med middelværdier på 312,0 ± 103,5 IE/l ved afslutningen af behandlingsperioden.
English: Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA.
Danish: Personer med IgA-deficiens kan potentielt udvikle IgAantistoffer og få anafylaktiske reaktioner efter administration af blodkomponenter med IgA.