FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines containing antibodies have been used in pregnant and breast-feeding women.
Danish: Ikke desto mindre er medicin med antistoffer blevet anvendt til gravide og ammende kvinder.
English: In most cases risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Danish: I de fleste tilfælde blev risikofaktorerne identificeret såsom præeksisterende nyreinsufficiens, diabetes mellitus, hypovolæmi, overvægt, samtidig brug af nefrotoksiske lægemidler eller alder over 65 år.
English: While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Danish: Selvom rapporterne om nyredysfunktion og akut nyresvigt er sat i forbindelse med brug af mange af de markedsførte IVIg-præparater, der indeholder forskellige hjælpestoffer såsom saccharose, glucose og maltose, tegnede de præparater, der indeholdt saccharose som stabilisator, sig for en uforholdsmæssigt stor andel af det samlede antal.
English: • 0.8 to 1g/kg bw given on day 1; this dose may be repeated once within 3 days
Danish: • 0,8 til 1,0 g/kg legemsvægt på dag 1; denne dosis kan gentages én gang i løbet af 3 dage
English: In post marketing reports it is observed that IVIG high-dose indications in children, particularly Kawasaki disease, are associated with an increased reporting rate of haemolytic reactions compared to other IVIG indications in children.
Danish: I indberetninger efter markedsføring er det observeret, at IVIG-højdosisindikationer hos børn, især med Kawasakis sygdom, er forbundet med en øget indberetning af hæmolytiske reaktioner sammenlignet med andre IVIG-indikationer hos børn.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Danish: Syndromet begynder normalt inden for adskillige timer til 2 dage efter IVIgbehandlingen.
English: For patients suffering from diabetes mellitus and requiring dilution of Privigen to lower concentrations, the presence of glucose in the recommended diluent should be taken into account.
Danish: Hos patienter, der lider af diabetes mellitus, og hvor fortynding af Privigen til lavere koncentrationer er nødvendig, skal der tages højde for, at den anbefalede fortyndingsvæske indeholder glucose.
English: It may happen particularly if you have developed antibodies against immunoglobulins of the type IgA.
Danish: Det kan især ske, hvis du har udviklet antistoffer mod immunglobuliner af typen IgA.
English: On the adjusted 10 point INCAT (Inflammatory Neuropathy Cause and Treatment) scale a clinically meaningful improvement of at least 1-point from baseline to treatment week 25 was observed in 17 out of 28 patients.
Danish: På den justerede 10 points INCAT- (Inflammatory Neuropathy Cause and Treatment) skala blev der observeret en klinisk betydningsfuld forbedring på mindst 1 point fra basislinje til behandlingsuge 25 hos 17 ud af 28 patienter.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Danish: 4.4 for at få yderligere oplysninger om risikofaktorer og anbefalinger om kontrol.
English: Distribution of the IgG subclasses (approx. values): IgG1 69 %
Danish: Fordeling af IgG-subklasser (omtrentlige værdier): IgG1 ...................... 69 %
English: The PID pivotal study included a total of 80 patients aged between 3 and 69 years old.
Danish: I det pivotale PID-studie deltog i alt 80 patienter i alderen mellem 3 og 69 år.
English: The mean improvement at the end of the treatment period compared to reference visit was 1.4 points in the PRIMA (1.8 points in IVIg pretreated subjects) and 1.2 points in PATH study.
Danish: Den gennemsnitlige vurdering i afslutningen af behandlingsperioden sammenlignet med referencebesøget var 1,4 point i PRIMA studiet (1,8 point i IVIg forbehandlede forsøgspersoner) og 1,2 point i PATH studiet.
English: The results of this study show the median half-life of Privigen to be 31.1 days (see table below).
Danish: I dette studie var den gennemsnitlige halveringstid af Privigen 31,1 dage (se tabellen herunder).
English: This will lead to non-heart related accumulation of fluid in the air spaces of the lungs (non-cardiogenic pulmonary oedema).
Danish: Dette medfører, at der ophober sig væske i lungernes luftrum uden relation til hjertet (ikke-kardiogent lungeødem).
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller CSL Behring GmbH
English: Will be placed in the upper right corner of the label to give total content and volume of the container
Danish: Anbringes i øverste højre hjørne af etiketten for at angive emballagens samlede indhold og mængde
English: In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions did not differ between children and adults.
Danish: I kliniske studier med Privigen hos pædiatriske patienter var der ingen forskel på bivirkningernes hyppighed, art og sværhedsgrad hos børn og voksne.
English: Contents of the pack and other information What Privigen contains
Danish: Pakningsstørrelser og yderligere oplysninger Privigen indeholder
English: The grip strength of the dominant hand improved by 14.1 kPa (17.0 kPa in IVIg-untreated and 10.8 kPa in IVIg pretreated subjects) in the PRIMA study, while in PATH the grip strength of the dominant hand improved by 12.2 kPa.
Danish: Gribestyrken i den dominante hånd blev forbedret med 14,1 kPa (17,0 kPa hos IVIg ubehandlede og 10,8 kPa hos IVIg forbehandlede forsøgspersoner) i PRIMA studiet, mens gribestyrken i den dominante hånd i PATH var blevet forbedret med 12,2 kPa.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Danish: Doseringen og intervallerne skal muligvis tilpasses det individuelle sygdomsforløb.
English: The scheduled dose of 1 g/kg bw per infusion was closely adhered to in all patients (median 2 g IgG/kg bw).
Danish: Den planlagte dosis på 1 g/kg legemsvægt pr. infusion blev nøje overholdt hos alle patienter (median 2 g IgG/kg legemsvægt).
English: Certain severe adverse reactions may be related to the rate of infusion.
Danish: Visse alvorlige bivirkninger kan skyldes infusionshastigheden.
English: Additional measures of CIDP improvement were an increase in R-ODS (Rasch-built Overall Disability Scale) score of ≥ 4 points, a mean grip strength increase of ≥ 8 kPa, or an MRC sum score increase of ≥ 3 points.
Danish: Ydeligere mål for CIDP forbedring var en stigning i R-ODS (Rasch-built Overall Disability Scale) score på ≤ 4 point, en stigning i middelgribestyrke ≤ 8 kPa eller en stigning i MRC sumscore på ≤ 3 point.
English: Tell your doctor prior to treatment.
Danish: Fortæl det til din læge før behandlingen.
English: For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Danish: Hyppigheden for spontane bivirkninger, der er indberettet efter markedsføring, er kategoriseret som ikke kendt.
English: In the case of measles vaccinations the impairment may persist for up to 1 year.
Danish: I tilfælde af mæslingevaccinationer kan virkningen være nedsat i op til 1 år.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: In all patients, IVIg administration requires: - adequate hydration prior to the initiation of the infusion of IVIg - monitoring of urine output - monitoring of serum creatinine levels - avoidance of concomitant use of loop diuretics.
Danish: IVIg-administrering kræver hos alle patienter: - Tilstrækkelig hydrering før IVIg-infusionen starter - Monitorering af diurese - Monitorering af serum-kreatinin - At samtidig brug af loop-diuretika undgås.
English: Hypersensitivity True hypersensitivity reactions are rare.
Danish: Rigtige overfølsomhedsreaktioner er sjældne.
English: Vaccinations Tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Danish: Vaccinationer Inden en vaccination skal du fortælle den vaccinerende læge om din behandling med Privigen.
English: Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Danish: Dalkoncentrationer skal måles og vurderes sammen med patientens kliniske respons.
English: If the treatment is effective, long term treatment should be subject to the physician's discretion based upon the patient response.
Danish: Hvis behandlingen er effektiv, skal langvarig behandling vurderes af lægen på baggrund af patientens respons.
English: Most adverse drug reactions (ADRs) observed in the six clinical studies were mild to moderate in nature.
Danish: De fleste bivirkninger, der blev observeret i de seks kliniske studier, var milde til moderate.
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 og D, kan interferere med nogle serologiske test for erytrocyt-antistoffer for eksempel den direkte antiglobulin test (DAT, direkte Coombs' test).
English: If signs and/or symptoms of haemolysis develop during or after an IVIg infusion, discontinuation of the IVIg treatment should be considered by the treating physician (see also section 4.8).
Danish: Hvis der udvikler sig tegn og/eller symptomer på hæmolyse under eller efter en IVIg-infusion, bør den behandlende læge overveje seponering af IVIg-behandlingen (se også pkt.
English: • increase in blood creatinine level,
Danish: • forhøjet blodkreatinin
English: Replacement therapy in primary immunodeficiency (PID) syndromes The dose regimen should achieve a trough IgG level (measured before the next infusion) of at least 5 to 6 g/l.
Danish: Substitutionsterapi ved primære immundefektsyndromer (PID) Dosisregimet bør opnå en mindste-koncentration (målt før næste infusion) for IgG på mindst 5 til 6 g/l.
English: At the beginning of the infusion you will receive Privigen at a slow infusion rate.
Danish: I begyndelsen får du indgivet Privigen ved en langsom indgivelseshastighed.
English: Guillain-Barré syndrome 0.4 g/kg bw/day over 5 days.
Danish: Guillain-Barrés syndrom 0,4 g/kg legemsvægt dagligt over 5 dage.
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Danish: Mindste-koncentration af IgG skal måles og vurderes sammen med forekomsten af infektion.
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.
Danish: Overdosering kan medføre væskeophobninger og hyperviskositet, især hos patienter i risikogruppen, herunder ældre patienter eller patienter med nedsat hjerte- eller nyrefunktion.
English: In patients at risk, the use of IVIg products that do not contain sucrose should therefore be considered.
Danish: Hos patienter i risikogruppen bør det overvejes at anvende IVIg-præparater, der ikke indeholder saccharose.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people.
Danish: Lægemidlet fungerer præcist på samme måde som de immunglobuliner, der findes naturligt i blodet hos mennesker.
English: Human normal immunoglobulin should be infused intravenously at an initial infusion rate of 0.3 ml/kg bw/hr for approximately 30 min.
Danish: Humant normalt immunglobulin skal infunderes intravenøst ved en initial infusionshastighed på 0,3 ml/kg/time i ca. 30 minutter.
English: The dosage recommendations are summarised in the following table:
Danish: Doseringsanbefalingerne fremgår af tabellen nedenfor:
English: • If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for fremsendelse af en periodisk, opdateret sikkerhedsindberetning (PSUR) er sammenfaldende med tidsfristen for opdatering af en RMP, kan de fremsendes samtidig.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i yderkarton for at beskytte mod lys.
English: The overall median time to first MRC sum score response in PRIMA was 6 weeks (6 weeks in the IVIg-untreated and 3 weeks in the IVIg-pretreated) and 9.3 weeks in PATH.
Danish: Den samlede mediane tid til første MRC sumscorerespons i PRIMA var 6 uger (6 uger hos de IVIg ubehandlede og 3 uger hos de IVIg forbehandlede) og 9,3 uger i PATH.
English: Solution for infusion (10%)
Danish: Infusionsvæske, opløsning (10 %)
English: The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1).
Danish: De farmakokinetiske parametre for Privigen blev bestemt i et klinisk studie af PID-patienter (se pkt.
English: Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Danish: Overfølsomhed over for humane immunglobuliner, specielt hos patienter med antistoffer mod IgA.
English: • The other ingredients (excipients) are the amino acid proline and water for injections.
Danish: ● Øvrige indholdsstoffer (hjælpestoffer): aminosyren prolin og vand til injektionsvæsker.
English: In PRIMA, the percentage of responders in the overall Medical Research Council (MRC) score (defined as an increase by ≥ 3 points) was 85 % (87 % in the IVIg-untreated and 82 % in IVIgpretreated) and 57 % in PATH.
Danish: I PRIMA studiet var procentdelen af respondenter i den samlede Medical Research Council (MRC) score (defineret som en stigning på ≤ 3 point) 85 % (87 % hos de IVIg ubehandlede og 82 % hos de IVIg forbehandlede) og 57 % i PATH studiet.
English: Overall, in 42 subjects (74 %) the platelet count increased at least once to ≥ 50×109 / l within 6 days after the first infusion, which was well within the expected range.
Danish: I alt steg trombocyttallet mindst én gang hos 42 patienter (74 %) til ≥50×109/l inden for 6 dage efter den første infusion, hvilket lå rigeligt inden for det forventede interval.
English: L-proline, water for injections.
Danish: L-prolin, vand til injektionsvæsker.
English: • temporary non-infectious meningitis (reversible aseptic meningitis), Tell your doctor or healthcare professional immediately if you have a stiff neck together with one or more of the following symptoms: fever, nausea, vomiting, headache, abnormal sensitivity to light, mental disturbances.
Danish: • midlertidig ikke-smitsom meningitis (reversibel aseptisk meningitis) fortæl det omgående til lægen eller sundhedspersonalet, hvis du har stiv nakke sammen med én eller flere af følgende symptomer: feber, kvalme, opkastning, hovedpine, unormal følsomhed til lette, mentale forstyrrelser
English: 13 children (3 to 11 years), 8 adolescents (12 to 15 years) and 34 adults were treated with Privigen over 29 months.
Danish: 13 børn (3-11 år), 8 teenagere (12-15 år) og 34 voksne blev behandlet med Privigen over 29 måneder.
English: He or she will decide whether to decrease the infusion rate or to stop the infusion completely.
Danish: Han eller hun vil beslutte, om infusionshastigheden skal sænkes, eller om infusionen skal stoppes helt.
English: Blood tests Tell your doctor about your treatment with Privigen prior to having any blood tests.
Danish: Fortæl din læge om din behandling med Privigen inden eventuelle blodprøver.
English: Once the vial has been entered under aseptic conditions, its contents should be used promptly.
Danish: Når hætteglasset er åbnet under aseptiske forhold, skal indholdet anvendes omgående.
English: • Keep the vial in the outer carton in order to protect from light.
Danish: • Opbevar flasken i yderkarton for at beskytte mod lys.
English: What Privigen is used for
Danish: Privigen anvendes til
English: Reversible haemolytic reactions have been observed in patients, especially those with non-O blood groups in immunomodulatory treatment.
Danish: Reversible hæmolytiske reaktioner er blevet observeret hos patienter, især patienter med andre blodtyper end 0, der er i immunmodulerende behandling.
English: Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin including Privigen.
Danish: Der er observeret tilfælde af reversibel aseptisk meningitis og sjældne tilfælde af forbigående hudreaktioner (herunder kutan lupus erythematosus - hyppighed ikke kendt) ved behandling med humant normalt immunglobulin, herunder Privigen.
English: Replacement therapy Primary immunodeficiency syndromes (PID)
Danish: Substitutionsbehandling Primær immundefektsyndromer (PID)
English: In these circumstances, immunoglobulins may increase the risk of serious rapid loss of kidney function (acute renal failure) although only very rarely.
Danish: Under disse omstændigheder kan immunglobuliner øge risikoen for alvorligt, hurtigt tab af nyrefunktion (akut nyresvigt), selvom det kun er meget sjældent.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Danish: Patienter, der oplever bivirkninger under behandlingen, bør vente med at føre motorkøretøj eller betjene maskiner, indtil disse er ophørt.
English: Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Danish: Det kan være nødvendigt at øge dosis hos patienter med vedholdende infektioner; en dosisreduktion kan overvejes, når patienten forbliver fri for infektioner.
English: Pivotal Study (N= 25) ZLB03_002CR Median (Range)
Danish: Pivotal studie (N=25) ZLB03 002CR Median (område)
English: Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment including Privigen (see section 4.4).
Danish: I sjældne tilfælde kan hæmolytisk anæmi, der kræver transfusion, udvikles efter behandling med høje doser IVIg, herunder Privigen (se pkt 4.4).
English: Flushing of the infusion tubes with physiological saline or 5% glucose solution is permitted.
Danish: Det er tilladt at skylle infusionsslangerne med fysiologisk saltvand eller en 5 % glucoseopløsning.
English: Thromboembolic events, vasculitis (including peripheral vascular disorder)
Danish: Tromboemboliske hændelser, vaskulitis (herunder perifer vaskulær sygdom)
English: IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Danish: Patienter, der får IVIg, bør overvåges for kliniske tegn og symptomer på hæmolyse.
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because antibodies against these infections, which are contained in the product, are protective.
Danish: • Antistoffer (immunglobuliner) er ikke blevet forbundet med hepatitis A- eller parvovirus B19Vinfektioner muligvis fordi antistoffer mod disse infektioner, som produktet indeholder, er beskyttende.
English: Package leaflet: Information for the user Privigen 100 mg/ml (10%) solution for infusion
Danish: Indlægsseddel: Information til brugeren Privigen 100 mg/ml (10 %) infusionsvæske, opløsning
English: Will be placed in the upper right corner of the main face of the box to give total content and volume of the container
Danish: Anbringes i øverste højre hjørne af forsiden på kartonen for at angive emballagens samlede indhold og mængde
English: In these circumstances, immunoglobulins may increase the risk of heart attack (cardiac infarction), stroke, blood clots in the lung (lung embolism), or blockage of a blood vessel in the leg, although only very rarely.
Danish: Under disse omstændigheder kan immunglobuliner øge risikoen for hjertetilfælde (hjerteinfarkt), slagtilfælde, blodprop i lungen (lungeemboli) eller blokering af et blodkar i benet, selvom det kun er meget sjældent.
English: In the case of measles, this impairment may persist for up to 1 year.
Danish: I tilfælde af mæslinger kan virkningen være nedsat i op til 1 år.
English: Very Common (may occur with more than 1 in 10 patients):
Danish: Meget almindelige: (kan forekomme hos flere end 1 ud af 10 patienter):
English: Isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.
Danish: Der er forekommet isolerede tilfælde af hæmolyserelateret nyredysfunktion/nyresvigt eller dissemineret intravaskulær koagulation og dødsfald.
English: Once the vial has been broached, its contents should be used promptly.
Danish: Når hætteglasset er brudt , skal indholdet anvendes omgående.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet er receptpligtigt (se bilag I: Produktresumé, pkt.
English: The dosage interval when steady state has been reached varies from 3 to 4 weeks.
Danish: Dosisintervallet efter opnået ligevægt varierer fra 3 til 4 uger.
English: 1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 40 g/400 ml), 3 vials (10 g/100 ml or 20 g/200 ml).
Danish: 1 hætteglas (2,5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml eller 40 g/400 ml), 3 hætteglas (10 g/100 ml eller 20 g/200 ml).
English: Your doctor will calculate the correct dose for you taking into account your weight, the specific circumstances listed under section 2 “Warnings and precautions” and response to treatment.
Danish: Din læge beregner den rette dosis for dig under hensyntagen til din vægt, de specifikke omstændigheder, der er angivet under pkt.
English: In the pivotal PID study, 80 patients were enrolled and treated with Privigen.
Danish: I det pivotale PID-studie blev 80 patienter behandlet med Privigen.
English: MRC sum score in PRIMA improved by 6.9 points (7.7 points for IVIg-untreated and 6.1 points for IVIg-pretreated) and by 3.6 points in PATH.
Danish: MRC sumscoren i PRIMA blev forbedret med 6,9 point (7,7 point for IVIg ubehandlede og 6,1 point for IVIg forbehandlede) og med 3,6 point i PATH.
English: • The active substance is human normal immunoglobulin (antibodies of the type IgG).
Danish: ● Aktive stof: humant normalt immunglobulin (antistoffer af typen IgG).
English: Such side effects may occur even if you have previously received human immunoglobulins and tolerated them well.
Danish: Sådanne bivirkninger kan forekomme, selvom du tidligere har fået indgivet humane immunglobuliner (antistoffer) og har tålt dem godt.
English: Privigen contains immunoglobulins that have been prepared from the blood of healthy people.
Danish: Privigen indeholder immunglobuliner, der stammer fra blod fra raske mennesker.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Danish: Fordelingen af immunglobulin G-subklasser er omtrent proportional med fordelingen i normalt humant plasma.
English: Transfusion-related acute lung injury (TRALI)
Danish: Transfusionsrelateret akut lungesygdom (TRALI)
English: Subjects all with IVIg pretreatment of at least 8 weeks and with an IVIg-dependence confirmed by clinically evident deterioration during an IVIg withdrawal phase of up to 12 weeks, received a Privigen loading dose of 2 g/kg bw followed by up to 4 Privigen maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks.
Danish: Forsøgspersoner, der alle have fået IVIg forbehandling i mindst 8 uger og med en IVIg afhængighed, der var bekræftet af klinisk evident forværring under en IVIg afvænningsfase i op til 12 uger, fik en Privigen begyndelsesdosis på 2 g/kg legemsvægt efterfulgt af op til 4 Privigen vedligeholdelsesdoser på 1 g/kg legemsvægt hver 3. uge i op til 13 uger.