FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de yderligere studier og pharmacovigilanceaktiviteter, der er beskrevet i pharmacovigilance-planen, i henhold til version 1.3 af risikostyringsprogrammet (RMPlan), præsenteret i Module 1.8.2. i ansøgningen om markedsføringstilladelsen, og enhver efterfølgende opdatering af risikostyringsplanen, der vedtages af CHMP.
English: Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Danish: Overfølsomhed over for humane immunglobuliner, særligt i de meget sjældne tilfælde af IgA-mangel, hvor patienten har antistoffer mod IgA.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Take special care with ImmunoGam General warnings related to ImmunoGam:
Danish: Vær ekstra forsigtig med at bruge ImmunoGam Generelle advarsler i forbindelse med ImmunoGam:
English: ImmunoGam does not effect your ability to drive or use machines.
Danish: ImmunoGam påvirker ikke din evne til at føre motorkøretøj eller betjene maskiner.
English: ImmunoGam belongs to a group of medicines containing immunoglobulins (antibodies which can protect against certain infections), which are present in your blood.
Danish: ImmunoGam tilhører en gruppe lægemidler, der indeholder immunglobuliner (antistoffer, der kan beskytte mod visse infektioner), som findes i blodet.
English: Instruction for Use and Handling and Disposal
Danish: Instruktioner vedrørende håndtering og destruktion
English: The product information of the blood glucose testing systems, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products.
Danish: Produktinformationen for blodglukosetestsystemerne, inklusive teststrips, skal læses omhyggeligt for at afgøre, om det pågældende system er egnet til brug med maltoseholdige parenterale produkter.
English: ImmunoGam contains small amounts of IgA.
Danish: ImmunoGam indeholder små mængder IgA.
English: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Danish: Hvis der opstår mistanke om allergiske eller anafylaktiske reaktioner, skal indsprøjtningerne omgående ophøre.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV.
Danish: De anvendte forholdsregler betragtes som effektive for indkapslede virus som HIV, HBV og HCV.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at et pharmacovigilance-system, som beskrevet i Modul 1.8.1. i ansøgningen om markedsføringstilladelse (version 2.0), er etableret og fungerer, før produktet kommer
English: Depending on the nature and severity of the allergic reaction, your doctor may give you an additional treatment or your doctor may decide to stop the
Danish: Afhængigt af typen af den allergiske reaktion, og hvor alvorlig den er, kan lægen vælge at ordinere en supplerende behandling eller afbryde
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 indsprøjtning af immunglobulin kan den midlertidige stigning i de forskellige passivt overførte antistoffer i patientens blod medføre falsk positive resultater ved serologiske test.
English: Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods) falsely interpret the maltose contained in ImmunoGam as glucose.
Danish: Visse typer blodglukosetestsystemer (eksempelvis systemer baseret på metoder med GDH-PQQ (glukosedehydrogenase-pyrroloquinolinequinon) eller glukose-dye-oxidoreduktase) fortolker fejlagtigt maltosen i ImmunoGam som glukose.
English: Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBsAg).
Danish: Humant hepatitis B-immunglobulin indeholder hovedsageligt immunglobulin G (IgG) med et specifikt højt indhold af antistoffer mod hepatitis B-overfladeantigen (HBsAg).
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ}
English: If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously if no intravenous medicinal product is available.
Danish: Hvis intramuskulær indgivelse er kontraindiceret (blødningsforstyrrelser), kan injektionen indgives subkutant, såfremt der ikke findes et intravenøst lægemiddel.
English: ADR frequency category*
Danish: Hyppighed af bivirkninger*
English: 8-12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion following vaccination.
Danish: 8-12 IE/kg, dog maksimalt 500 IE, hver 2. måned, til der konstateres serokonvertering efter vaccination.
English: In all these situations, vaccination against hepatitis B virus is highly recommended.
Danish: I alle disse situationer anbefales det på det kraftigste at vaccinere mod hepatitis B-virus.
English: This also applies to unknown or emerging viruses and
Danish: Dette gælder også ukendte eller nyopståede
English: Repeated-dose toxicity testing and embryo-fetal toxicity studies are impractical due to induction of, and interference with antibodies.
Danish: Undersøgelser af toksicitet efter gentagne doser samt embryoføtal toksicitet er ikke praktisk mulige på grund af induktion og påvirkning af antistoffer.
English: If any uncertainty exists, the manufacturer of the testing system should be contacted to determine if the system is appropriate for use with
Danish: I tilfælde af usikkerhed skal producenten af testsystemet kontaktes for at fastslå, om det pågældende system er egnet til brug med maltoseholdige parenterale
English: Human hepatitis B immunoglobulin for intramuscular use is bioavailable in the recipient's circulation after a delay of 2 - 3 days.
Danish: Humant hepatitis B-immunglobulin til intramuskulær anvendelse er biotilgængeligt i recipientens kredsløb efter en forsinkelse på 2-3 dage.
English: • Patients should be monitored for antibodies against human hepatitis B immunoglobulin regularly.
Danish: • Patienter bør regelmæssigt undersøges for antistoffer mod menneskeligt hepatitis B-immunglobulin.
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
Danish: Der er betryggende klinisk erfaring vedrørende mangel på overførsel af hepatitis A eller parvovirus B19 med immunglobuliner, og det antages ligeledes, at antistofindholdet bidrager væsentligt til den virale sikkerhed.
English: Undesirable effects reported during clinical trials with ImmunoGam, that was administered intramuscularly (injected into a muscle), were uncommon (affects 1 to 10 users in 1,000).
Danish: Bivirkninger indberettet under kliniske forsøg med ImmunoGam, der blev indgivet intramuskulært (indsprøjtet i en muskel), og som vurderes at være forbundet med ImmunoGam, var ikke almindelige (påvirkede mellem 1 og 10 ud af 1.000 behandlede).
English: - Immunoprophylaxis of hepatitis B in haemodialysed patients:
Danish: - Immunprofylakse af hepatitis B hos hæmodialysepatienter:
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: Standardprocedurer til forebyggelse af infektioner, der skyldes brug af lægemidler fremstillet af humant blod eller plasma, inkluderer udvælgelse af donorer, screening for bestemte infektionsmarkører i de enkelte donationer og i poolet plasma samt implementering af effektive tiltag til inaktivering/fjernelse af vira under fremstillingen.
English: It is clear to slightly opalescent and
Danish: Den er klar eller let opaliserende og
English: If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
Danish: Hvis patienten er bærer af HBsAg, opnås der ingen gavnlig virkning ved indgivelse af dette lægemiddel.
English: No effects on ability to drive and use machines have been observed.
Danish: Der er ikke observeret nogen påvirkning af evnen til at føre motorkøretøj eller betjene maskiner.
English: In case of shock, standard medical treatments for shock should be implemented.
Danish: I tilfælde af shock, skal der gives en passende standardbehandling for shock.
English: The physician must therefore weigh the benefit of treatment with ImmunoGam against potential risk of hypersensitivity reactions.
Danish: Lægen bør derfor afveje fordelene ved ImmunoGam-behandlingen mod den potentielle risiko
English: Please tell your doctor immediately if you experience any of the following symptoms after o hives, flushed skin or rash, swelling of a specific area such as the injection site or face o chest tightness, shortness of breath, wheezing o rapid increase in heart beat, sudden drop in blood pressure and/or shock These symptoms may be early signs of an allergic reaction.
Danish: Fortæl det straks til lægen, hvis du får nogen af de følgende symptomer efter at have fået o nældefeber, udslæt eller rødmen på huden, hævelse på bestemte steder, f.eks. ved o trykken for brystet, vejrtrækningsbesvær, hiven efter vejret o kraftig pulsstigning, pludseligt blodtryksfald og/eller shock Disse symptomer kan være tidlige tegn på en allergisk reaktion.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed from blood donors on to patients.
Danish: Når lægemidler fremstilles af blod eller plasma, der stammer fra mennesker, træffes der en række forholdsregler for at forhindre, at patienterne bliver smittet med infektioner fra bloddonorer.
English: Immunoglobulins are excreted into milk but no harmful effects on the neonate are to be expected.
Danish: Immunglobuliner udskilles i modermælken, men der forventes ikke skadelige påvirkninger af den nyfødte.
English: • Store in a refrigerator (2 to 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: These undesirable effects were reported within the first 7 days after receiving ImmunoGam: nausea, fatigue, induration (swelling and firmness) at the injection site, feeling unwell, pain, fever, joint pain, back pain, muscle pain, headache and dizziness.
Danish: Disse uønskede bivirkninger blev indberettet inden for de første 7 dage efter brug af ImmunoGam: Kvalme, træthed, induration (opsvulmen og hårdhed) ved indsprøjtningsstedet, utilpashed, smerter, feber, ledsmerter, rygsmerter, muskelsmerter, hovedpine og svimmelhed.
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 påvirke udviklingen af immunrespons på vacciner med levende svækket virus, f.eks. rubella, fåresyge, mæslinger og varicella, i en periode på 3 måneder.
English: • Do not use ImmunoGam if the solution appears cloudy or has deposits.
Danish: • Brug ikke ImmunoGam, hvis opløsningen er uklar eller har bundfald.
English: This is because Some types of blood glucose testing systems falsely interpret the maltose contained in ImmunoGam as glucose.
Danish: Dette skyldes, at visse systemer til blodsukkermåling fejlagtigt fortolker maltosen i ImmunoGam som glukose.
English: - Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably
Danish: - Forebyggelse af hepatitis B i tilfælde af utilsigtet eksponering af ikke-vaccinerede personer: Mindst 500 IE afhængigt af eksponeringsintensiteten - snarest muligt efter eksponering og helst inden for
English: Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for imtramuscular use.
Danish: Der skal tages hensyn til øvrige officielle retningslinjer for korrekt brug af humant hepatitis B-immunglobulin til intramuskulær anvendelse.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON
English: If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this
Danish: Hvis der kræves stor volumen (> 2 ml til børn eller > 5 ml til voksne), anbefales det at fordele den på flere doser,
English: The frequency of possible side effects listed below is defined using the following convension: - very common (affects more than 1 user in 10) - common (affects 1 to 10 users in 100) - uncommon (affects 1 to 10 users in 1,000) - rare (affects 1 to 10 users in 10,000) - very rare (affects less than 1 user in 10,000) - not known (frequency cannot be estimated from the available data)
Danish: Hyppigheden af mulige bivirkninger angivet nedenfor er defineret på følgende måde: - meget almindelig (forekommer hos flere end 1 ud af 10 behandlede) - almindelig (forekommer hos mellem 1 og 10 ud af 100 behandlede) - ikke almindelig (forekommer hos mellem 1 og 10 ud af 1.000 behandlede) - sjælden (forekommer hos mellem 1 og 10 ud af 10.000 behandlede) - meget sjælden (forekommer hos færre end 1 ud af 10.000 behandlede) - ikke kendt (hyppighed kan ikke bedømmes ud fra forhåndenværende data)
English: For intramuscular administration, ImmunoGam should be injected into the upper part of the shoulder (deltoid muscle), or into the right part of the thigh in the front (anteriolateral thigh) in newborn children.
Danish: Ved indsprøjtning i en muskel skal ImmunoGam indsprøjtes i den øverste del af skulderen (overarmsmusklen) eller i den højre del af låret på forsiden (anterolateralt) hos nyfødte.
English: Patients who have an IgA deficiency may develop an allergic reaction to this medicine.
Danish: Patienter, der lider af IgA-mangel, kan udvikle allergiske
English: - Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion following vaccination.
Danish: - Immunprofylakse af hepatitis B hos hæmodialysepatienter: 8-12 IE/kg, dog maksimalt 500 IE, hver 2. måned, indtil der konstateres serokonvertering efter
English: * Frequency has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Danish: * Hyppigheden er blevet evalueret ud fra følgende kriterier: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til <1/10), ikke almindelig (≥ 1/1.000 til < 1/100).
English: The table below provides a recommended dose.
Danish: Den anbefalede dosis ses i nedenstående oversigt.
English: Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or
Danish: - Forebyggelse af hepatitis B hos nyfødte, hvor moderen er bærer af hepatitis B-virus, ved fødslen eller
English: It is strongly recommended that every time ImmunoGam 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
Danish: Det anbefales på det kraftigste, at lægemidlets navn og batchnummer registreres, hver gang en patient får indgivet ImmunoGam, så der kan påvises en forbindelse mellem patienten og det pågældende lægemiddelbatch.
English: Also transmission of antibodies to blood group antigens may interfere with some blood tests for red cell allo-antibodies (e.g. Coombs' test).
Danish: Overførslen af antistoffer mod blodtypeantigener kan desuden påvirke visse blodprøver af alloantistoffer i røde blodceller (f.eks. Coombs' test).
English: If a large volume (greater than 2 ml for children or greater than 5 ml for adults) is required, it is recommended that the administration of ImmunoGam be divided doses at different sites.
Danish: Hvis der skal bruges store mængder (mere end 2 ml til børn eller mere end 5 ml til voksne), anbefales det, at ImmunoGam fordeles på flere doser, der indsprøjtes forskellige steder.
English: - The active substance is Human hepatitis B immunoglobulin.
Danish: - Aktivt stof: humant hepatitis B-immunglobulin.
English: Accordingly, when administering ImmunoGam or other parenteral maltose-containing products, the measurement of blood glucose must be done with a glucose-specific method.
Danish: Ved indgivelse af ImmunoGam eller andre parenterale maltoseholdige lægemidler skal blodglukosen derfor måles med en glukosespecifik metode.
English: • Human hepatitis B immunoglobulin injections can induce a drop in blood pressure with an allergic reaction, even in patients who have tolerated previous treatments with immunoglobulin.
Danish: • Indsprøjtninger af humant hepatitis B-immunglobulin kan give blodtryksfald i forbindelse med en allergisk reaktion - også hos patienter, der tidligere har tålt behandlinger med immunglobulin.
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-mangel kan udvikle IgA-antistoffer og kan derfor udvise anafylaktiske reaktioner efter indgivelse af blodkomponenter indeholdende IgA.
English: • There are no available data on drug interactions of ImmunoGam with other medications.
Danish: • Det vides ikke, om ImmunoGam reagerer med andre lægemidler.
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell allo-antibodies (e.g.Coombs' test).
Danish: Den passive overførsel af antistoffer mod erytrocytantigener, f.eks. A, B og D, kan påvirke visse serologiske test af alloantistoffer i røde blodceller (f.eks. Coombs' test).
English: ImmunoGam contains 0.16 g of maltose in a 500 IU dose.
Danish: ImmunoGam indeholder 0,16 g maltose i en dosis på 500 IE. Der bør tages hensyn til dette hos patienter med
English: No data is available in the event of an overdose.
Danish: Der findes ingen data om overdosering.
English: In case of intramuscular administration, some discomfort may occur occasionally at the site of injection such as local pain or tenderness.
Danish: Ved indsprøjtning i en muskel kan der forekomme ubehag på indsprøjtningsstedet, f.eks. lokale smerter eller ømhed.
English: Immunoglobulins are normal constituents of the human body.
Danish: Immunglobuliner forekommer naturligt i menneskekroppen.
English: In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
Danish: Hos personer, der ikke har udvist immunrespons (ingen målbare hepatitis B-antistoffer) efter vaccination, men har behov for fortsat forebyggelse, kan det overvejes at indgive 500 IE til voksne og 8 IE/kg til børn hver anden måned.
English: ImmunoGam is supplied in a Type 1 glass vial with a siliconized bromobutyl rubber stopper, aluminum seal and
Danish: ImmunoGam udleveres i et type 1-glas-hætteglas med en silikoniseret brombutylgummiprop,
English: When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
Danish: Hvis det er nødvendigt med samtidig vaccination, skal immunglobulin og vaccine indsprøjtes på to forskellige indgivelsessteder.
English: Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.
Danish: Tilfælde af egentlig hypoglykæmi risikerer endvidere ikke at blive behandlet, hvis den hypoglykæmiske tilstand skjules af falsk forhøjede glukoseaflæsninger.
English: - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
Danish: - Hos personer, der ikke har udvist immunrespons (ingen målbare hepatitis B-antistoffer) efter vaccination, og som har brug for kontinuerlig forebyggelse på grund af den fortsatte risiko for infektion med hepatitis B.
English: One vial of 1 ml contains 312 IU of anti-HBs.
Danish: Ét hætteglas på 1 ml indeholder 312 IE anti-HB-antistoffer.
English: The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
Danish: De anvendte forholdsregler har muligvis begrænset virkning på ikke-indkapslede virus som HAV og parvovirus B19.
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: ImmunoGam is a clear to slightly opalescent and colourless or pale yellow liquid.
Danish: ImmunoGam er en klar til let opaliserende og farveløs eller svagt gul opløsning.
English: - if you have an IgA deficiency such that you have developed an allergic reaction to IgA containing products
Danish: - hvis du lider af IgA-mangel, så du har udviklet allergiske reaktioner over for medicin, der indeholder IgA.
English: One vial of 5 ml contains 1560 IU of anti-HBs.
Danish: Ét hætteglas på 5 ml indeholder 1560 IE anti-HB-antistoffer.
English: One vial contains 312 IU of anti-HBs in 1 ml One vial contains 1560 IU of anti-HBs in 5 ml
Danish: Ét hætteglas indeholder 312 IE anti-HB-antistoffer i 1 ml opløsning Ét hætteglas indeholder 1.560 IE anti-HB-antistoffer i 5 ml opløsning
English: When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two
Danish: Hvis det er nødvendigt med samtidig vaccination, skal immunglobulin og vaccinen indsprøjtes på to forskellige
English: This may result in falsely elevated glucose readings and consequently in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia.
Danish: Dette kan give falsk forhøjede glukoseaflæsninger og medføre fejlagtig indgivelse af insulin, hvilket kan resultere i livstruende hypoglykæmi.
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 immunoglobulin.
Danish: I sjældne tilfælde kan humant hepatitis B-immunglobulin medføre blodtryksfald med anafylaktiske reaktioner, også hos patienter, der har tålt tidligere behandlinger med immunglobulin.
English: Vaccination against hepatitis B virus is highly recommended.
Danish: Det anbefales på det kraftigste at vaccinere mod hepatitis B-virus.
English: The solution should be clear to slightly opalescent and colourless or pale yellow.
Danish: Opløsningen skal være klar eller let opaliserende og farveløs eller svagt gul.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Danish: Kliniske erfaringer med immunglobuliner tyder på, at der ikke kan forventes skadelige påvirkninger af graviditetens
English: For intramuscular administration of ImmunoGam, the only manifestations of overdose would be pain and tenderness at the injection site.
Danish: Ved indsprøjtning af ImmunoGam i en muskel viser overdosering sig kun som smerter og ømhed på indsprøjtningsstedet.