FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are HBs antigen positive you will not receive Zutectra since there is no benefit in administering this medicine to you.
Danish: Hvis du er HBs-antigen-positiv, får du ikke Zutectra, idet der ikke er nogen fordel ved at give dig medicinen.
English: Talk to your doctor about managing the dose.
Danish: Tal med din læge om, hvordan du skal håndtere den glemte dosis.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 500 IE
English: Please tell your doctor or healthcare professional immediately if you notice any reactions during your injection with Zutectra.
Danish: Fortæl det til lægen eller til sundhedspersonalet med det samme, hvis du oplever en reaktion ved injektion med Zutectra.
English: This is likely to be the easiest place to inject if you are doing it yourself.
Danish: Maven vil formentlig være det nemmeste sted, når du selv foretager injektionen.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Producenterne af denne medicin har også en række foranstaltninger i behandlingen af blod eller plasma til at inaktivere eller fjerne virus.
English: Hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Danish: Hepatitis B-immunglobulin indeholder hovedsageligt immunglobulin G (IgG) med et særligt højt indhold af antistoffer mod hepatitis B-virus overfladeantigen (HBs).
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Danish: Når man fremstiller medicin af humant blod eller plasma, tages der en række forholdsregler for at undgå, at infektioner overføres til patienten.
English: Open each syringe only when you are ready for an injection.
Danish: Åbn først en sprøjte, når du er klar til en injektion.
English: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Danish: Ved mistanke om allergiske eller anafylaktiske reaktioner skal injektionen straks afbrydes.
English: You should rotate the injection site at every injection.
Danish: Du skal skifte injektionssted for hver injektion.
English: If some areas are too difficult for you to reach, you may need a caregiver to help you with these injections.
Danish: Hvis et sted er for svært at komme til, skal du måske have hjælp af en plejer eller en ven til denne injektion.
English: No treatment failure defined as positive HBV-DNA and HBsAg findings occurred during the entire observation period.
Danish: Behandlingssvigt, defineret som positive HBVDNA- og HBsAg-resultater, blev ikke observeret i observationsperioden.
English: Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Danish: I sjældne tilfælde kan humant hepatitis B-immunglobulin inducere et fald i blodtrykket med en anafylaktisk reaktion, selv hos patienter som har tolereret tidligere behandling med humant immunglobulin.
English: The weekly subcutaneous dose was 500 IU for patients with bodyweight < 75 kg (a dose increase to 1000 IU was allowed, if medically required to maintain a safety level of > 100 IU) and 1000 IU for patients with bodyweight ≥ 75 kg. 2 patients received a higher and 2 patients received a lower dose than recommended by the weight based dosing regimen.
Danish: Den ugentlige subkutane dosis var 500 IE for patienter med en kropsvægt < 75 kg (dosen kunne øges til 1000 IE, hvis der var et medicinsk behov for at fastholde et sikkerhedsniveau på > 100 IE) og 1000 IE for en kropsvægt ≥ 75 kg. 2 patienter modtog en højere og 2 patienter en lavere dosis end anbefalet af det vægtbaserede doseringsregime.
English: What Zutectra contains
Danish: Zutectra indeholder
English: In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels > 100 IU/l after extended periods between level controls.
Danish: Endvidere skal patienten eller plejeren følge injektionsteknikken og doseringsregimet for at sikre et laveste antiHBs-serumniveau på > 100 IE/l efter en længere periode mellem niveaukontrollerne.
English: This is very rare and may result in allergic reactions.
Danish: Dette er meget sjældent og kan give et allergisk shock.
English: Most side effects observed with Zutectra were mild to moderate in nature.
Danish: De fleste bivirkninger med Zutectra, var lette til moderate.
English: Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing.
Danish: Inden initiering af subkutan behandling med Zutectra skal adækvat serumniveau af anti-HB stabiliseres med intravenøs hepatitis B-immunglobulin til et niveau på eller over 300-500 IE/l for at sikre tilstrækkelig anti-HBs-dækning ved overgangen fra intravenøs til subkutan dosering.
English: Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
Danish: Serum-anti-HBs-antistof skal måles mindst hver 2.-4. uge i mindst et halvt år efter den ansvarlige læges skøn.
English: - Hold the syringe with the needle pointing upwards, and tap the syringe gently with your fingers until the air has collected at the tip.
Danish: - Hold sprøjten, så kanylen peger opad, og bank let på sprøjten med fingrene, indtil luften samler sig i spidsen.
English: Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit.
Danish: Komplians i henhold til anti-HBs-serumniveau kunne dokumenteres for 57 (af 61) patienter (93 %), hvor ingen værdier lå under 100 IE/l, og det gennemsnitlige anti-HBs-serumniveau var 254,3 IE/l ved det afsluttende besøg.
English: The > 100 IU/l safety margin is the generally accepted level of effective prevention against HBV re-infection in liver transplant patients at risk.
Danish: Sikkerhedsmarginen på 100 IE/l er det generelt accepterede niveau for effektiv forebyggelse mod HBV-reinfektion hos udsatte levertranslationspatienter.
English: Please tell your doctor about your treatment with Zutectra prior to any vaccination.
Danish: Fortæl lægen om din behandling med Zutectra inden enhver form for vaccination.
English: METHOD OF ADMINISTRATION Subcutaneous use
Danish: ADMINISTRATIONSMETODE Subkutan anvendelse
English: If you are administering Zutectra yourself, please read instructions in the section “How to inject Zutectra by yourself or by caregiver” carefully.
Danish: Hvis du selv injicerer Zutectra, skal du nøje læse vejledningen i afsnittet “Sådan injicerer du selv eller din plejer Zutectra”.
English: There is reassuring clinical experience 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 findes bekræftende klinisk erfaring vedrørende manglende overførsel af hepatitis A eller parvovirus B19 med immunglobuliner, og det antages, at antistofindholdet bidrager væsentligt til den virale sikkerhed.
English: Get rid of any air bubbles that may be in the syringe.
Danish: Fjern eventuelle luftbobler i sprøjten.
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 humane normale immunglobuliner forårsage et pludseligt fald i blodtrykket og i enkelte tilfælde anafylaktisk shock, selv når patienten ikke har udvist nogen overfølsomhed ved tidligere administration.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Zutectra, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Zutectra på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: One non-serious adverse event was reported to be related to Zutectra (injection site haematoma).
Danish: En ikke-alvorlig bivirkning blev rappporteret som værende relateret til Zutectra (hæmatom på injektionsstedet).
English: Inject the liquid by pressing gently on the plunger.
Danish: Injicer væsken ved at trykke forsigtigt på stemplet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE
English: In total, 42/61 patients (68.9 %) used antiviral medication and 19 patients received monotherapy with Zutectra during this study.
Danish: I alt 42/61 patienter (68,9 %) fik antiviralt lægemiddel, og 19 patienter fik monoterapi med Zutectra i dette studie.
English: After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Danish: Efter indgivelse af lægemidlet skal der gå mindst 3 måneder, inden vaccination med levende, svækkede virusvacciner.
English: Zutectra is used to prevent re-infection of hepatitis B in adults who have had a liver transplant at least 1 week ago because they had liver failure caused by hepatitis B.
Danish: Zutectra anvendes til forebyggelse af reinfektion af hepatitis B hos voksne, som har gennemgået en levertransplantation for mindst 1 uge siden på grund af leversvigt forårsaget af hepatitis B.
English: In total, 53/66 patients (80.3 %) used antiviral medication and 13 patients received monotherapy with Zutectra during this study.
Danish: I alt 53/66 patienter (80,3 %) fik antiviralt lægemiddel, og 13 patienter fik monoterapi med Zutectra i dette studie.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zutectra 500 IU injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zutectra 500 IE injektion
English: No clinical signs of a hepatitis B re-infection were observed and no patient was tested HBsAg positive or HBV-DNA positive during the study which confirms that effective protection against Hepatitis B virus re-infection was provided by subcutaneous administration of Zutectra as part of the combination treatment with HBV virostatic therapy 8 - 18 days after orthotopic liver transplantation.
Danish: Der blev ikke observeret nogen kliniske tegn på hepatitis B-reinfektion, og ingen patienter blev testet HbsAgpositive eller HBV-DNA-positive i løbet af studiet, hvilket bekræfter, at effektiv beskyttelse mod hepatitis B-virus-reinfektion blev opnået med subkutan administration af Zutectra som en del af kombinationsregimet med HBV-virostatisk behandling 8-18 dage efter ortotopisk levertransplantion.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If you get any side effects, talk to your doctor, healthcare professional or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sundhedspersonalet eller apoteket.
English: The objective of the study was to evaluate the level of compliance of patients using subcutaneous Zutectra as home selftreatment for preventing hepatitis B re-infection.
Danish: Formålet med studiet var at vurdere graden af komplians hos patienter, som selvadministrerede Zutectra subkutant i hjemmet for at forebygge hepatitis B-reinfektion.
English: - Take the needle out of its sterile pack and fit the needle onto the syringe.
Danish: - Tag kanylen ud af den sterile pakning, og sæt den på sprøjten.
English: The objectives of the open, prospective, single-arm clinical trial were the investigation of feasibility of home self-administration (including patient compliance), efficacy and safety of subcutaneous application of Zutectra in a population of stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver in 66 patients.
Danish: Formålene med det åbne, prospektive, enkeltarmede kliniske studie var at undersøge mulighederne for selvadministration i hjemmet (herunder patientkomplians) samt virkning og sikkerhed ved subkutan anvendelse af Zutectra i en population bestående af stabile patienter i langtidsbehandling for at forebygge reinfektion i en transplanteret lever.
English: Live attenuated virus vaccines
Danish: Levende, svækkede virusvacciner
English: Do not use Zutectra if you notice that the solution is cloudy or has particles.
Danish: Brug ikke Zutectra, hvis opløsningen er grumset eller indeholder partikler.
English: Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Danish: Immunglobuliner såsom Zutectra er ikke set ved hepatitis A- eller parvovirus B19-infektioner, muligvis fordi antistofferne i medicinen mod disse infektioner har en beskyttende effekt.
English: The starting material or what Zutectra is made from is human blood plasma (this is the liquid part of the blood).
Danish: Zutectra er fremstillet af humant blodplasma (den flydende del af blodet).
English: Clean the injection site by wiping it in a circular motion with the alcohol swab.
Danish: Rengør injektionsstedet ved at tørre det af i en cirkelbevægelse med sprittamponen.
English: Avoid surgical scars.
Danish: Undgå operationsar.
English: Serum HBs antibody concentrations above the minimum safety trough level of >100 IU/L were measured in all patients at all timepoints independent of the type of administration (investigator, caregiver or self-injection), the dose regimen (500 IU, 1000 IU, 1500 IU) or the treatment intervals.
Danish: HBs-antistofkoncentration i serum over det laveste sikkerheds-dalniveau på >100 IE/l blev målt hos alle patienter på alle tidspunkter, uafhængigt af administrationstype (investigator, plejer eller selvinjektion), dosisprogram (500 IE, 1.000 IE, 1.500 IE) eller behandlingsinterval.
English: Please tell your doctor about your treatment with Zutectra prior to any blood test.
Danish: Fortæl lægen om din behandling med Zutectra inden en blodprøve.
English: Once the injection has been completed, dispose of all needles, syringes and empty glass containers without delay in a container intended for sharp objects you were provided with.
Danish: Når injektionen er udført, bortskaffes alle kanyler, sprøjter og tomme glasbeholdere straks i en beholder til skarpe genstande, som du har fået udleveret.
English: Prepare the Zutectra syringe:
Danish: Gør Zutectra-sprøjten klar:
English: Nasopharyngitis
Danish: Nasofaryngitis
English: The solution must be brought to room temperature before use.
Danish: Opløsningen skal have stuetemperatur inden brug.
English: Uncommon (may affect up to 1 in 100 people): - headache - upper abdominal pain (from your chest to the belly button)
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer): hovedpine mavesmerte (i området fra brystet til navlen)
English: Serum antiHBs trough levels of 100 IU/l and higher (primary efficacy endpoint) were maintained for all patients during the 18 to 24 week trial period.
Danish: Laveste serum-HBsniveau på 100 IE/l og derover (primært effektivitetsendepunkt) blev opretholdt for alle patienter i studieperioden på 18 til 24 uger.
English: Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): reaktion på injektionsstedet: smerte, nældefeber (udslæt) på injektionsstedet, hæmatom (blodansamling i vævet under huden), hudrødme (erytem).
English: The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra.
Danish: Det åbne, prospektive, enkeltarmede kliniske studie omfattede 23 modtagere af en levertransplantation, som havde fået profylakse med intravenøst hepatitis B-immunglobulin med efterfølgende skift til subkutant Zutectra.
English: Then pull the needle out immediately and let go of the pinched skin.
Danish: Træk kanylen ud med det samme og slip huden, du kneb sammen.
English: Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months.
Danish: Indgivelse af immunglobulin kan interferere med udviklingen af et immunrespons mod levende, svækkede virusvacciner såsom røde hunde, fåresyge, mæslinger og skoldkopper i en periode på 3 måneder.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods for dette vil man ved indgivelse af lægemidler fremstillet af humant blod eller -plasma ikke fuldstændigt kunne udelukke muligheden for at overføre infektiøse agenser.
English: 5 pre-filled syringes
Danish: 5 fyldte injektionssprøjter
English: Injection site reactions like pain, urticaria at injection site, haematoma and erythema
Danish: Reaktioner på injektionsstedet som smerter, urticaria på injektionsstedet, hæmatom og erytem
English: The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B reinfection prophylaxis.
Danish: Samtidig brug af adækvate virostatiske stoffer skal overvejes som almindelig reinfektions-profylakse med hepatitis B-virus.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SPRØJTE
English: - Remove the protective cap from the syringe.
Danish: - Fjern beskyttelseshætten fra sprøjten.
English: The active substance is human hepatitis B immunoglobulin 500 IU/ml.
Danish: Aktivt stof: Humant hepatitis B-immunglobulin 500 IE/ml.
English: The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Danish: Det bedste sted for en injektion er der, hvor huden er løs og blød, fx maven, armen, låret eller ballerne, og på afstand af led, nerver og knogler.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Zutectra findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Pharmacotherapeutic group: Immune sera and immunoglobulins, Specific immunoglobulins, Hepatitis B immunoglobulin
Danish: Farmakoterapeutisk klassifikation: Immunsera og immunglobuliner, specifikke immunglobuliner, hepatitis B-immunglobulin
English: MedDRA System Organ Class
Danish: MedDRA-systemorganklasse Bivirkninger
English: The following instructions are intended to explain how to inject Zutectra.
Danish: Den følgende vejledning forklarer, hvordan du selv foretager injektion med Zutectra.
English: In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels.
Danish: Hos HBV-DNA-negative voksne mindst en uge efter levertransplantation: subkutane injektioner af Zutectra ugentligt eller hver 14. dag i henhold til laveste anti-HBs-serumniveau.
English: Upper abdominal pain
Danish: Smerter i øvre abdomen
English: Do not use solutions that are cloudy or have particles.
Danish: Brug ikke en opløsning, der er grumset eller indeholder partikler.
English: Driving and using machines Zutectra has no or negligible effects on your ability to drive or use machines.
Danish: Zutectra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) weekly or fortnightly.
Danish: Dosis kan fastlægges individuelt og justeres fra 500 IE op til 1.000 IE (i særlige tilfælde op til 1.500 IE) ugentligt eller hver 14. dag.
English: Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Danish: Humant protein 150 mg/ml, hvoraf mindst 96 % er IgG, med et indhold af antistoffer mod hepatitis Bvirus-overfladeantigen (HBs) på 500 IE/ml.
English: In case of any adverse event after the injection speak to your doctor immediately.
Danish: Hvis der opstår bivirkninger efter injektionen, skal du straks fortælle det til din læge.
English: two alcohol swabs, one syringe of Zutectra, one needle suitable for subcutaneous injection.
Danish: to sprittamponer, en sprøjte med Zutectra, en kanyle, der er egnet til subkutan injektion (injektion under huden).
English: The measures taken 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.
Danish: Forholdsreglern anses for effektive mod kappebærende virusser såsom humant immundefekt virus (HIV), hepatitis B-virus og hepatitis C-virus og for ikke-kappebærende hepatitis A-virus.
English: Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany
Danish: Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Tyskland
English: One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
Danish: Én ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med prop (brombutyl) og låg (brombutylgummi).
English: At the time of transplantation 21 patients (42.9%) were tested positive for HDV, patients with a positive HIV or HCV test were excluded from study participation.
Danish: På transplantationstidspunktet blev 21 patienter (42,9 %) testet positive for HDV.
English: It is hard to pinch up the tissue and inject Zutectra yourself using this site.
Danish: Det er svært at klemme væv sammen og selv foretage injektion af Zutectra på det sted.
English: Zutectra is intended for subcutaneous (under the skin) injection.
Danish: Zutectra er beregnet til subkutan injektion (injektion under huden).
English: Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.
Danish: Hvis det er afgørende at indgive humant hepatitis B-immunglobulin i løbet af tre til fire uger efter vaccination, skal revaccination udføres tre måneder efter administrationen af humant hepatitis B-immunglobulin.
English: Once the injection has been completed, dispose of all needles and empty glass containers without delay in a container intended for sharp objects.
Danish: Når injektionen er udført, bortskaffes alle kanyler og tomme glasbeholdere straks i beholderen til skarpe genstande.