FrancophonIA/ELRC3.0 huggingface dataset:
English: If you receive Privigen while you are breast-feeding the antibodies in this medicine will also be found in the breast milk.
Danish: Hvis du får indgivet Privigen, mens du ammer, findes antistofferne i dette lægemiddel også i modermælken.
English: The two CIDP studies were performed with 28 and 207 patients, respectively.
Danish: De to CIDP studier blev foretaget på henholdsvis 28 og 207 patienter.
English: A) to increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy):
Danish: A) Til at forøge unormalt lave immunglobulinniveauer i blodet til normale niveauer (substitutionsterapi):
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Danish: Patienterne bør samtidig behandles med acetylsalicylsyre.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særligt som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Previously treated patients were withdrawn from IVIG until confirmed deterioration before start of Privigen.
Danish: Tidligere behandlede patienter blev trukket ud af IVIG indtil en bekræftet svækkelse før start på Privigen.
English: Although limited data is available, it is expected that the same warnings, precautions and risk factors apply to the paediatric population.
Danish: Selvom der kun foreligger begrænsede data, forventes det, at de samme advarsler, forholdsregler og risikofaktorer gælder for den pædiatriske population.
English: In this study, the median half-life of Privigen in PID patients was 36.6 days.
Danish: I dette studie var den gennemsnitlige halveringstid af Privigen hos PID-patienter 36,6 dage.
English: Dizziness (including vertigo)
Danish: Svimmelhed (herunder vertigo)
English: After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Danish: Efter administration af dette produkt bør der gå tre måneder inden vaccination med levende svækkede virusvacciner.
English: Aseptic technique must be strictly observed during the dilution of Privigen.
Danish: Aseptisk teknik skal strengt overholdes under fortyndingen af Privigen.
English: After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Danish: Efter at have fået indgivet Privigen kan virkningen af visse vaccinationer være svækket.
English: This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a heart or kidney disease.
Danish: Dette kan især ske, hvis du er en patient, der er i risikogruppe, hvis f.eks. du er ældre eller lider af en hjerte- eller nyresygdom.
English: You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Danish: Du vil normalt blive overvåget under hele infusionen og i mindst 20 minutter herefter.
English: The product should be brought to room temperature (25°C) before use.
Danish: Lægemidlet skal have rumtemperatur (25 °C) før brug.
English: Patients with hyperprolinaemia type I or II.
Danish: Patienter med hyperprolinæmi type I eller II.
English: In replacement therapy the dose may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Danish: Ved substitutionsterapi kan der være behov for individuel dosis til den enkelte patient afhængigt af farmakokinetisk og klinisk respons.
English: Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
Danish: Mulige bivirkninger kan reduceres eller endda undgås ved at indgive Privigen ved en langsom indgivelseshastighed.
English: • You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Danish: • Du kan være overfølsom (allergisk) over for immunglobuliner uden at vide det.
English: Six clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP.
Danish: Der blev foretaget seks kliniske studier med Privigen, som inkluderede patienter med PID, ITP og CIDP.
English: • if you suffer from hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Danish: • hvis du lider af hyperprolinæmi type I eller II (en genetisk lidelse, der forårsger høje niveauer af aminosyren prolin i blodet).
English: B) to treat certain inflammatory disorders (immunomodulation).
Danish: B) Til at behandle visse betændelsestilstande (immunmodulation).
English: As this event was commonly reported in non-O blood group patients receiving high doses for non-PID indications, increased vigilance is recommended.
Danish: Da denne hændelse hyppigt blev rapporteret hos patienter, der ikke har blodtype 0, og som får høje doser for ikke-PID-indikationer, tilrådes øget årvågenhed.
English: • you are receiving Privigen at a high infusion rate or
Danish: • du får indgivet Privigen ved en høj indgivelseshastighed eller
English: 12.3 (10.4-18.8) (3-week schedule) 9.4 (7.3-13.2) (4-week schedule)
Danish: 12,3 (10,4-18,8) (3-ugers skema) 9,4 (7,3-13,2) (4-ugers skema)
English: The posology in children and adolescents (0-18 years) is not different from that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Danish: Doseringen til børn og unge (0-18 år) adskiller sig ikke fra den, der anvendes til voksne, da doseringen for hver indikation afhænger af legemsvægten og tilpasses det kliniske resultat af ovennævnte tilstande.
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Danish: Seponering af IVIg-behandlingen har resulteret i remission af AMS i løbet af adskillige dage uden følgevirkninger.
English: The following dose regimens are given as a guideline.
Danish: De følgende doseringsregimer er vejledende.
English: Long-term experience has shown that no harmful effects during the course of the pregnancy or to the newborn are to be expected.
Danish: Langtidserfaring har vist, at der ikke kan forventes skadelige indvirkninger under graviditetsforløbet eller på den nyfødte.
English: Although Privigen does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which could affect your blood sugar level.
Danish: Selvom Privigen ikke indeholder sukker, kan det være fortyndet med en særlig sukkeropløsning (5 % glucose), hvilket kan påvirke dit blodsukkerniveau.
English: 1038 infusions were administered, 272 (in 16 patients) in the 3-week schedule and 766 (in 64 patients) in the 4-week schedule.
Danish: 1038 infusioner blev administreret, 272 (hos 16 patienter) i 3-ugers planen og 766 (hos 64 patienter) i 4-ugers planen.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Danish: Patienter skal monitoreres og observeres nøje for eventuelle symptomer i hele infusionsperioden.
English: Privigen contains proline
Danish: Privigen indeholder prolin
English: Contains 3 vials.
Danish: Indeholder 3 hætteglas.
English: Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Danish: Immunglobuliner kendes også som antistoffer og er blodproteiner, der hjælper kroppen med at bekæmpe infektioner.
English: • Do not use this medicine if you notice that the solution is cloudy or contains particles floating within the solution.
Danish: • Brug ikke dette lægemiddel, hvis du bemærker, at injektionsvæskeen er uklar eller indeholder partikler, der flyder rundt i opløsningen.
English: The maximum IgA content is 25 micrograms/ml.
Danish: Det maksimale IgA-indhold er 25 mikrogram/ml.
English: This also applies to any unknown or emerging viruses and other types of infections.
Danish: Dette gælder også alle ukendte eller nye vira og andre infektionstyper.
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Danish: IVIgpræparater er vist at passere placenta, i stigende grad efter tredje trimester.
English: In post marketing reports it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults.
Danish: I rapporter efter markedsføring er det observeret, at andelen af hæmolysetilfælde i forhold til alle bivirkningsrapporter blandt børn er lidt større end hos voksne.
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 forbigående stigning af forskellige passivt overførte antistoffer i patientens blod føre til falsk positive resultater ved serologiske test.
English: TRALI may be managed using oxygen therapy with adequate ventilatory support.
Danish: TRALI kan behandles med oxygenbehandling med adækvat ventilering.
English: Do NOT take Privigen
Danish: Brug IKKE Privigen
English: Some published studies pertaining to hyperprolinaemia have shown that longterm, high doses of L-proline have effects on brain development in very young rats.
Danish: Nogle publicerede studier vedrørende hyperprolinæmi har vist, at høje langtidsdoser af Lprolin påvirker hjerneudviklingen hos meget unge rotter.
English: Please also refer to section 2 “What you need to know before you are given Privigen” for additional details on circumstances which increase the risk of side effects.
Danish: 2 “Det skal du vide, før du begynder at få Privigen” for at få yderligere oplysninger om forhold, som øger risikoen for at få bivirkninger.
English: Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG.
Danish: Privigen indeholder 100 mg/ml (10 %) humant protein, hvoraf mindst 98 % er IgG.
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:
Danish: I sjældne og isolerede tilfælde er der set de følgende bivirkninger med immunglobulinpræparater:
English: Therefore, patients receiving measles vaccine should have their antibody status checked.
Danish: Patienter, som får mæslingevaccine, bør derfor få deres antistofstatus kontrolleret.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også ukendte eller nye vira og andre patogener.
English: The safety and efficacy of Privigen was evaluated in 6 prospective, open-label, single-arm, multicenter studies performed in Europe (ITP, PID and CIDP studies) and the USA (PID study).
Danish: Privigens sikkerhed og virkning blev evalueret i 6 prospektive, open-label, multicenterstudier af enkeltgrupper, foretaget i Europa (ITP-, PID- og CIDP-studier) samt i USA (PID-studie).
English: It is characterised by inflammation of blood vessels throughout the body.
Danish: Den er karakteriseret ved betændelse i hele kroppens blodkar.
English: AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Danish: AMS kan forekomme hyppigere i forbindelse med højdosis (2 g/kg) IVIg-behandling.
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Danish: • Brug ikke dette lægemiddel efter den udløbsdato, som står på den ydre pakning og flaskens etiket efter Anv.
English: Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of Privigen.
Danish: Fortæl det omgående til lægen eller sundhedspersonalet, hvis du bemærker sådanne tegn under infusionen af Privigen.
English: A vented infusion line should be used for the administration of Privigen.
Danish: Der skal anvendes en separat infusionsslange til administration af Privigen.
English: The safety of Privigen has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Danish: Privigens sikkerhed er blevet vurderet i flere prækliniske studier med særlig reference til hjælpestoffet L-prolin.
English: Privigen belongs to the class of medicines called human normal immunoglobulins.
Danish: Privigen hører til lægemiddelgruppen, der kaldes humane normale immunglobuliner.
English: After receiving Privigen, the results of certain blood tests (serological tests) may be impaired for a certain time.
Danish: Efter at du har fået indgivet Privigen kan resultaterne af visse blodprøver (serologiske prøver) være svækket i et bestemt stykke tid.
English: 771 infusions were administered and the median dose administered was 492.3 mg IgG/kg bw.
Danish: 771 infusioner blev administreret og den mediane administrerede dosis var 492,3 mg IgG/kg legemsvægt.
English: Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Danish: Der er kun begrænset erfaring med intravenøs brug af immunglobuliner hos børn med CIPD.
English: Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Danish: Afhængigt af den kliniske respons (f.eks. infektionshyppigheden) kan det overvejes at justere dosis og/eller dosisintervallet for at tilstræbe højere mindste-koncentrationer.
English: Experimental studies of the excipient L-proline carried out in animals found no direct or indirect toxicity affecting pregnancy, embryonal or foetal development.
Danish: Eksperimentelle studier af hjælpestoffet L-prolin udført på dyr, fandt ikke nogen direkte eller indirekte toksicitet der påvirkede graviditet, embryo- eller fosterudvikling.
English: Special precautions
Danish: Særlige forholdsregler
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Danish: Farmakoterapeutisk klassifikation: immunsera og immunglobuliner: normale humane immunglobuliner til intravaskulær administration, ATC-kode: J06BA02.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl.
Danish: Undersøgelse af cerebrospinalvæsken er hyppigt positiv for pleocytose med op til flere tusinde celler pr. mm3, hovedsageligt forskellige typer granulocytter, og forhøjede proteinniveauer op til flere hundrede mg/dl.
English: 25 patients (aged 13-69 years) participated in the pharmacokinetic (PK) assessment.
Danish: 25 patienter (mellem 13-69 år) deltog i den farmakokinetiske vurdering.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in the section below.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført herunder.
English: * PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Danish: * PSAF = manglende evne til at opnå mindst en stigning til det dobbelte i IgG-antistoftiter for pneumokok polysaccharid- og popypeptid antigen-vacciner.
English: The information given should be taken into consideration by you and your doctor before you are given Privigen.
Danish: Du og din læge skal tage hensyn til den angivne information, før du får Privigen.
English: • if you have developed antibodies against immunoglobulins of the type IgA in your blood.
Danish: • hvis du har udviklet antistoffer over for immunglobulin af typen IgA i dit blod.
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 medicin fremstilles af blod fra mennesker eller plasma, træffes der visse forholdsregler for at forhindre, at der overføres infektioner til patienterne.
English: Monitor patients for pulmonary adverse reactions.
Danish: Monitorér patienter for pulmonale bivirkninger.
English: Following clinical deterioration during IVIg withdrawal, clinical improvement of CIDP was primarily defined by a decrease of ≥ 1 point at the adjusted INCAT score.
Danish: Efter klinisk forværring under IVIg afvænning blev klinisk forbedring af CIDP primært defineret som et fald på ≤ 1 point i den justerede INCAT score.
English: Pharmacokinetic parameters of Privigen in PID patients Parameter
Danish: Farmakokinetiske parametre for Privigen hos PID-patienter Parameter
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 and breast-feeding mothers.
Danish: Sikkerheden ved brugen af lægemidlet under graviditet er ikke påvist i kontrollerede kliniske studier, og der bør derfor udvises forsigtighed ved ordinering til gravide og ammende kvinder.
English: Stability after dilution:
Danish: Stabilitet efter fortynding:
English: Therefore, your vaccinating doctor should check the effectiveness of the measles vaccination.
Danish: Derfor skal den vaccinerende læge kontrollere virkningen af mæslingevaccinationen.
English: Excipients with known effects: Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Privigen indeholder ca. 250 mmol/l (i området: 210 til 290) L-prolin.
English: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Switzerland or
Danish: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Schweiz eller
English: This medicine contains trace amounts of IgA (not more than 25 micrograms/ml).
Danish: Dette lægemiddel indeholder spormidler af IgA (ikke mere end 25 mikrogram/ml).
English: The duration of treatment beyond 25 weeks should be subject to the physician's discretion based upon the patient response and maintenance response in the long-term.
Danish: Behandlingsvarighed ud over 25 uger skal baseres på lægens vurdering af patientens respons og vedligeholdelsesresponset på lang sigt.
English: They can occur in patients with anti-IgA antibodies.
Danish: De kan forekomme hos patienter med anti-IgAantistoffer.
English: • Periodic Safety Update Reports
Danish: • Periodiske sikkerhedsopdateringsrapporter (PSUR)
English: Proteinuria, increased blood creatinine
Danish: Proteinuri, forhøjet kreatinin i blodet
English: However, true allergic reactions are rare.
Danish: Ægte overfølsomhedsreaktioner er dog sjældne.
English: Vomiting, diarrhoea, abdominal pain
Danish: Opkastning, diarré, abdominalsmerter
English: Aseptic meningitis
Danish: Aseptisk meningitis
English: In case of renal impairment, IVIg discontinuation should be considered.
Danish: I tilfælde af nedsat nyrefunktion bør seponering af IVIg overvejes.
English: The two ITP studies were performed with 57 patients each.
Danish: De to ITP studier blev foretaget med 57 patienter i hver.
English: Increase in serum creatinine level and/or acute renal failure have been observed.
Danish: Forhøjet serumkreatinin og/eller akut nyresvigt er observeret.
English: The following table shows an overview of the ADRs observed in the six clinical studies categorized according the MedDRA System Organ Class (SOC), Preferred Term Level (PT) and frequency.
Danish: I nedenstående tabel vises en oversigt over de bivirkninger, der blev observeret i de seks kliniske studier i overensstemmelse med MedDRAs systemorganklasser (systemorganklasse og foretrukken term) og hyppighed.
English: Palpitations, tachycardia
Danish: Palpitationer, takykardi
English: Patients may experience effects, such as dizziness or nausea, during treatment with Privigen that might affect the ability to drive and use machines.
Danish: Patienter kan opleve virkninger som svimmelhed eller kvalme under behandling med Privigen, som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The product should be brought to room or body temperature before use.
Danish: Lægemidlet skal have rum- eller legemstemperatur før brug.
English: In the ITP pivotal study, in total 57 patients aged between 15 and 69 years old were treated with 2 infusions of Privigen for a total of 114 infusions.
Danish: I det pivotale ITP-studie blev i alt 57 patienter i alderen mellem 15 og 69 år behandlet med 2 infusioner Privigen ved i alt 114 infusioner.
English: In a second prospective, multicenter randomized, placebo-controlled clinical study (Polyneuropathy and Treatment with Hizentra, PATH trial), 207 subjects with CIDP were treated with Privigen in the prerandomization phase of the study.
Danish: I et andet prospektivt, randomiseret, placebo-kontrolleret, klinisk multicenterstudie (Polyneuropathy and Treatment with Hizentra, PATH studiet), blev 207 forsøgspersoner med CIDP behandlet med Privigen i prærandomiseringsfasen af studiet.
English: The following risk factors are associated with the development of haemolysis: high doses, whether given as a single administration or divided over several days; non-O blood group; and underlying inflammatory state.
Danish: Følgende risikofaktorer er forbundet med udvikling af hæmolyse: høje doser, uanset om de gives som en enkelt administration eller fordeles over flere dage, andre blodtyper end 0 samt underliggende inflammatorisk tilstand.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Danish: Humant normalt immunglobulin indeholder hovedsageligt immunglobulin G (IgG) med et bredt spektrum af antistoffer mod infektiøse agenser.
English: Anisocytosis (including microcytosis), thrombocytosis
Danish: Anisocytose (herunder mikrocytose, trombocytose
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: Standardforholdsregler til forebyggelse af infektioner, der skyldes brug af lægemidler, der er fremstillet af humant blod eller plasma, omfatter udvælgelse af donorer, screening af enkeltdonationer og plasmapools for specifikke infektionsmarkører samt inkludering af effektive trin til inaktivering/eliminering af vira som en del af fremstillingsproceduren.
English: In these circumstances, it has been commonly reported that immunoglobulins increase the risk of breakdown of red blood cells (haemolysis).
Danish: Under disse omstændigheder rapporteres det hyppigt, at immunglobuliner øger risikoen for nedbrydning af røde blodlegemer (hæmolyse).
English: 19 children (3 to 11 years), 12 adolescents (12 to 16 years) and 49 adults were treated with Privigen over 12 months.
Danish: 19 børn (3-11 år), 12 teenagere (12-16 år) og 49 voksne blev behandlet med Privigen over 12 måneder.
English: Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
Danish: t½ (dage) Cmax: maksimal serumkoncentration; Cmin: minimal serumkoncentration; t½: elimineringshalveringstid
English: Cmax (peak, g/l) Cmin (trough, g/l)
Danish: Cmax (maksimum, g/l) Cmin (minimum, g/l)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: Tell your doctor or healthcare professional prior to treatment if any of the circumstances listed below applies to you:
Danish: Tal med lægen eller sundhedspersonalet før behandlingen, hvis nogen af nedenstående omstændigheder gælder for dig:
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Danish: Klinisk erfaring med immunglobuliner indikerer, at der ikke forventes skadelige virkninger på fertiliteten.