FrancophonIA/ELRC3.0 huggingface dataset:
English: This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Danish: Denne halveringstid kan variere fra patient til patient, især ved primær immundefekt.
English: • monitoring for signs and symptoms of thrombosis
Danish: • monitorering for tegn og symptomer på trombose
English: Dose and frequency of the infusion will vary depending on your condition and your body weight.
Danish: Dosis og infusionshyppighed vil variere afhængigt af din tilstand og din kropsvægt.
English: • If you have already received KIOVIG previously and received the last treatment recently, then you will only be observed during the infusion and for at least 20 minutes after your infusion.
Danish: • Hvis du allerede har fået KIOVIG tidligere og fået den sidste behandling for nylig, vil du kun blive observeret under infusionen og i mindst 20 minutter efter infusionen.
English: The values obtained in the studies are comparable to parameters reported for other human immunoglobulins.
Danish: De fundne værdier i undersøgelserne er sammenlignelige med de parametre, der er registreret for andre humane immunglobuliner.
English: It is given to you by your doctor or nurse.
Danish: Din læge eller sygeplejerske giver dig den.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Danish: Virkningsmekanismen i andre indikationer end substitutionsterapi er ikke helt belyst, men omfatter immunmodulatoriske virkninger.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal almindelig behandling for shock påbegyndes.
English: It is distributed relatively rapidly between plasma and extravascular fluid; after approximately 3 to 5 days equilibrium is reached between the intra- and extravascular compartments.
Danish: Det fordeles relativt hurtigt mellem plasma og ekstravaskulær væske; efter cirka 3 til 5 dage opnås en balance mellem de intra- og ekstravaskulære rum.
English: The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
Danish: Virkningen af behandlingen bør vurderes efter hvert forløb, hvis der ikke ses nogen virkning af behandlingen efter 6 måneder, bør behandlingen afbrydes.
English: No evidence is available to require a dose adjustment.
Danish: Der foreligger ingen data, der kræver dosisjustering.
English: In all patients, IVIg administration requires:
Danish: Hos alle patienter kræver indgivelse af IVIg:
English: In addition, children with Kawasaki Disease are at especially high risk due to underlying cardiac compromise so dose and rate of administration should be carefully controlled.
Danish: Dertil kommer, at børn med Kawasakis sygdom har en særlig høj risiko på grund af underliggende kardiale komplikationer, derfor skal dosis og administrationshyppighed kontrolleres nøje.
English: Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Danish: Patienter, der udviser sådanne tegn og symptomer bør få en grundig neurologisk undersøgelse, herunder CSF-undersøgelser for at udelukke andre årsager til meningitis.
English: No negative effects on the breastfed newborn/infants are anticipated.
Danish: Der forudses ingen negative virkninger på diende nyfødte/spædbørn.
English: It is recommended that during dilution the risk of microbial contamination is minimised.
Danish: Det anbefales, at risikoen for mikrobiel kontaminering minimeres under fortynding.
English: Increase in serum creatinine level and/or acute renal failure have been observed.
Danish: Stigning i serumkreatinin-niveau og/eller akut nyresvigt er blevet iagttaget.
English: • assessment of blood viscosity in patients at risk for hyperviscosity
Danish: • vurdering af blodets viskositet hos patienter med risiko for hyperviskositet
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Danish: Substitutionsterapi skal igangsættes og monitoreres under supervision af en læge med erfaring i behandling af immundefekter.
English: • If you are breast-feeding and receive KIOVIG, the antibodies of the medicine can also be found in the breast milk.
Danish: • Hvis du ammer og får KIOVIG, kan antistofferne fra medicinen også findes i mælken.
English: Children (12 years or below)
Danish: Børn (12 år eller yngre)
English: • in case of high rate of infusion
Danish: • i tilfælde af en høj infusionshastighed
English: This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days.
Danish: Dette forekommer normalt inden for timer eller dage efter indgivelse af IVIg og opklares spontant inden for 7 til 14 dage.
English: Instructions for handling and disposal
Danish: Instruktioner for håndtering samt bortskaffelse
English: Maintenance doses:
Danish: Vedligeholdelsesdoser:
English: The posology in children and adolescents (0-18 years) is not different to 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: Dosering for børn og unge (0-18 år) er ikke forskellig for voksne, da doseringen for hver indikation er angivet efter kropsvægt og justeret til det kliniske resultat for ovennævnte tilstande.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.
Danish: Dette kan især forekomme, hvis du er en patient, der er udsat for risiko, f.eks. en ældre patient eller en patient, der har problemer med nyrerne.
English: • in patients with an untreated infection or underlying chronic inflammation.
Danish: • hos patienter med en ubehandlet infektion eller underliggende kronisk inflammation.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Danish: Dosering og intervaller skal måske tilpasses i henhold til det individuelle sygdomsforløb.
English: Muscle twitching and weakness were reported only in patients with MMN.
Danish: Muskeltrækninger og muskelsvaghed blev kun rapporteret hos patienter med MMN.
English: KIOVIG belongs to a class of medications called immunoglobulins.
Danish: KIOVIG hører til en klasse af medicin, der kaldes immunglobuliner.
English: For example, if you have an immunoglobulin A deficiency, you may have antibodies against immunoglobulin A in your blood.
Danish: For eksempel, hvis du har immunglobulin A-mangel, har du muligvis antistoffer mod immunglobulin A i dit blod.
English: Other routes of administration have not been evaluated.
Danish: Andre indgivelsesveje er ikke blevet evalueret.
English: Therefore patients receiving measles vaccine should have their antibody status checked.
Danish: Derfor bør patienter, der får vaccine mod mæslinger, have deres status for antistoffer kontrolleret.
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Danish: Passende doser af dette lægemiddel kan bringe abnormt lave immunglobulin G-niveauer op i normalområdet.
English: TRALI is a potentially lifethreatening condition requiring immediate intensive-care-unit management.
Danish: TRALI er en potentielt livstruende tilstand, der kræver øjeblikkelig behandling på intensivafdelingen.
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: Dosis bør justeres efter behov for at opnå optimal beskyttelse mod infektioner, en øgning kan være nødvendig hos patienter med vedvarende infektion, en nedsættelse af dosis kan overvejes, når patienten er infektionsfri.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Danish: Patienterne bør få ledsagende behandling med acetylsalicylsyre.
English: Smaller children below the age of 5 years may be particularly susceptible to volume overload.
Danish: Mindre børn under 5 år er specielt følsomme for hypervolæmi.
English: Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur.
Danish: Det er nødvendigt med tre til seks måneder efter påbegyndelsen af terapien for, at der kan opnås ligevægt (steady state lgG-niveauer).
English: Be sure that you take adequate fluids so you are not dehydrated and notify your physician if you are known to have medical problems.
Danish: Sørg for at drikke rigeligt med væske, så du ikke dehydrerer, og giv din læge besked, hvis du har kendte medicinske problemer.
English: Medicines like KIOVIG are used in patients who do not have enough antibodies in their blood and tend to get frequent infections.
Danish: Lægemidler som KIOVIG anvendes til patienter, som ikke har antistoffer nok i deres blod og har tendens til at få hyppige infektioner.
English: Frequency of injections
Danish: Hyppighed af injektioner
English: There are no paediatric specific risks with regard to any of the above adverse events.
Danish: Der er ingen specifikke risici for børn for så vidt angår nogen af ovenstående bivirkninger.
English: Glycine Water for injections
Danish: Glycin Vand til injektionsvæsker
English: • Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2).
Danish: • Kawasakis sygdom (sammen med acetylsalicylsyre, se 4.2).
English: Dependent on how comfortable you are, your doctor may then gradually increase the infusion rate.
Danish: Afhængigt af, hvordan du har det, kan din læge derefter gradvist øge infusionshastigheden.
English: If you have a blood test after receiving KIOVIG, please inform the person taking your blood or your doctor that you have received the medication.
Danish: Hvis du får taget en blodprøve efter at have fået KIOVIG, bedes du underrette den, der tager blodprøven, eller din læge om, at du har fået medicinen.
English: Information on the source material of KIOVIG
Danish: Information om KIOVIG's kildemateriale
English: In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.
Danish: I substitutionsterapi kan det være nødvendigt med individuel dosering til hver enkelt patient afhængigt af den farmakokinetiske og kliniske respons.
English: This may happen particularly if you suffer from immunoglobulin A deficiency.
Danish: Dette kan især forekomme, hvis du lider af immunglobulin A-mangel.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for ukendte eller opdukkende vira eller andre typer af infektioner.
English: • The other ingredients (excipients) are glycine and water for injections.
Danish: • Øvrige indholdsstoffer (hjælpestoffer): glycin og vand til injektionsvæsker.
English: In these studies, a total of 83 subjects at least 2 years of age were treated with doses of 300 to 600 mg/kg body weight every 21 to 28 days for 6 to 12 months.
Danish: I disse undersøgelser blev i alt 83 forsøgspersoner med en alder på mindst 2 år behandlet med doser på 300 til 600 mg/kg kropsvægt hver 21. til 28. dag i 6 til 12 måneder.
English: The trough levels should be maintained above 5g/l.
Danish: Dalkoncentrationerne bør opretholdes på over 5g/l.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også for ukendte eller opdukkende vira og andre patogener.
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: Mens disse rapporter om renal dysfunktion og akut nyresvigt er blevet forbundet med brugen af mange af de godkendte IVIg-produkter, som indeholder forskellige hjælpestoffer som saccharose, glucose og maltose, tegnede de, der indeholder saccharose som stabilisator, sig for en uforholdsmæssig stor andel af det samlede antal.
English: • No clinical trials have been made with KIOVIG in pregnant or breast-feeding women.
Danish: • Der har ikke været udført kliniske undersøgelser med KIOVIG med gravide eller ammende kvinder.
English: The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabellerne herunder er i overensstemmelse med MedDRA organklassificering (SOC og foretrukken betegnelse).
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Danish: Hyppigheden, typen og sværhedsgraden af bivirkninger hos børn er de samme som hos voksne.
English: Pharmacokinetic parameters for the product are summarized in the table below.
Danish: Farmakokinetiske parametre for præparatet er sammenfattet i nedenstående tabel.
English: Distribution of IgG subclasses (approx. values):
Danish: Fordeling af IgG-underklasser (cirkaværdier):
English: 3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Danish: 3, hovedsageligt fra granulocytiske serier, og forhøjede proteinniveauer på op til adskillige hundrede mg/dl. AMS kan opstå hyppigere i forbindelse med IVIg-behandling med høj dosis (2 g/kg).
English: Since KIOVIG contains trace amounts of immunoglobulin A (less than 0.14 mg/ml), you might get an allergic reaction.
Danish: Da KIOVIG indeholder spormængder af immunglobulin A (op til 0,14 mg/ml), kan du måske få en allergisk reaktion.
English: AUC0-21d (g·h/dl) (area under the curve)
Danish: AUC0-21d (g·h/dl) (areal under kurven)
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Danish: Afbrydelse af IVIg behandling har resulteret i remission af AMS inden for adskillige dage uden følgesygdomme.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Dosering der er baseret på legemsvægt kan kræve justering hos under- eller overvægtige patienter.
English: Talk to your doctor, pharmacist or nurse before using KIOVIG.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger KIOVIG.
English: A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs.
Danish: Et forbigående fald i neutrofiltal og/eller neutropeniepisoder, nogle gange alvorlige, er blevet rapporteret efter behanding med IVIg.
English: If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response.
Danish: Hvis behandlingen virker på længere sigt, bør behandlingen være underlagt lægens skøn baseret på patientens respons og vedligeholdelsesrespons.
English: These medicines contain human antibodies, which are also present in your blood.
Danish: Disse lægemidler indeholder humane antistoffer, der alle findes i blodet.
English: 10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
Danish: 10, 25, 50, 100, 200 eller 300 ml opløsning i et hætteglas (type I glas) med en prop (brombutyl).
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: • Ethvert uanvendt præparat samt affaldsmateriale skal bortskaffes i overensstemmelse med lokale krav.
English: KIOVIG is intended for intravenous administration (infusion into a vein).
Danish: KIOVIG er bestemt til at anvendes intravenøst (infusion i en vene).
English: • If KIOVIG is administered at a high rate, if you suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia), if you have not received this medicine before or if there has been a long interval (e.g. several weeks) since you last received it, there may be a higher risk of side effects.
Danish: • Hvis KIOVIG indgives med en høj hastighed, hvis du lider af en tilstand med lave antistof niveauer i blodet (hypo- eller agammaglobulinæmi), hvis du ikke har fået dette lægemiddel før, eller hvis der har været et langt interval (f.eks. flere uger), siden du sidst fik det, kan der være større risiko for bivirkninger.
English: Anaphylaxis can develop in patients
Danish: Anafylaksi kan udvikles hos patienter
English: Since clinical experience provides no evidence for carcinogenic potential of immunoglobulins, no experimental studies in heterogeneous species were performed.
Danish: Da klinisk erfaring ikke giver evidens for immunglobuliners karcinogene potentiale, er der ikke udført eksperimentelle undersøgelse hos heterogene arter.
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with KIOVIG.
Danish: Evnen til at føre motorkøretøj og betjene maskiner kan blive nedsat ved visse bivirkninger forbundet med KIOVIG.
English: They can also be used in patients who need additional antibodies for the cure of certain inflammatory disorders (autoimmune diseases).
Danish: De kan også anvendes til patienter, der har behov for flere antistoffer i forbindelse med helbredelsen af visse betændelsestilstande (autoimmune sygdomme).
English: Administration of KIOVIG can lead to false positive readings in assays that depend on detection of beta-D-glucans for diagnosis of fungal infections.
Danish: Administration af KIOVIG kan medføre falsk positive resultater i analyser, der afhænger af detektion af beta-D-glukaner til diagnosticering af svampeinfektioner.
English: When medicines are made from human blood or plasma, a number of measures are put in place to prevent infections being passed on to patients.
Danish: Når der fremstilles lægemidler af humant blod eller plasma, bliver der truffet et antal forholdsregler for at forhindre, at infektioner overføres til patienter.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women and breast-feeding mothers.
Danish: Sikkerheden af dette lægemiddel er ikke blevet fastslået i kontrollerede kliniske studier, og derfor bør det kun gives med forsigtighed til gravide kvinder og mødre, der ammer.
English: From post-marketing data with KIOVIG no clear correlation of AMS to higher doses was observed.
Danish: Fra data efter markedsføringen blev der ikke observeret nogen tydelig forbindelse mellem AMS og højere doser af KIOVIG.
English: The dose and dose regimen is dependent on the indication.
Danish: Dosis og dosering afhænger af indikationen.
English: This should be taken into account by physicians, since initiation of treatment for true hyponatremia (i.e. decreasing serum free water) in these patients may lead to a further increase in serum viscosity and a possible predisposition to thromboembolic events.
Danish: Læger skal tage hensyn til dette, idet påbegyndelse af behandling af ægte hyponatriæmi (dvs. reduktion af serumfrit vand) hos patienter kan føre til en yderligere stigning i serumviskositeten og en mulig prædisposition for tromboemboliske hændelser.
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Danish: IgG-dalkoncentrationer bør måles og vurderes sammen med infektionshændelsen.
English: Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals.
Danish: Nyreparametre bør vurderes før infusion med IVIg, især hos patienter, der vurderes at have en mulig øget risiko for at udvikle akut nyresvigt, og igen ved passende intervaller.
English: • Guillain Barré syndrome.
Danish: • Guillain Barré syndrom.
English: After infusion 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 infusion af immunglobulin kan en forbigående stigning af de forskellige passivt overførte antistoffer i patientens blod resultere i misvisende positive resultater af serologiske tests.
English: To reduce the rate of bacterial infection, it may be necessary to increase the dose and aim for higher trough levels.
Danish: For at reducere hyppigheden af bakteriel infektion kan det være nødvendigt at forøge dosis og forsøge at opnå højere dalkoncentrationer.
English: Coombs direct test positive, oxygen saturation decreased
Danish: Coombs direkte test positiv, nedsat iltmætning Ikke kendt
English: • in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Danish: • hos patienter, der får humant normalt immunglobulin for første gang eller, i sjældne tilfælde, når det normale immunglobulinprodukt bliver udskiftet, eller når der har været et langt interval efter den forrige infusion.
English: In rare cases your body may have previously reacted to specific antibodies and therefore will be sensitive to medicines containing antibodies.
Danish: I sjældne tilfælde kan kroppen tidligere have reageret mod bestemte antistoffer, og den er derfor overfølsom over for lægemidler indeholdende antistoffer.
English: • Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), or problems with your blood vessels (vascular diseases).
Danish: • Din læge vil være ekstra forsigtig, hvis du er overvægtig, ældre, diabetiker eller hvis du lider af højt blodtryk, lav blodmængde (hypovolæmi) eller problemer med blodkarrene (vaskulære sygdomme).
English: KIOVIG also contains certain antibodies that can prevent an infection with hepatitis A virus and parvovirus B19.
Danish: KIOVIG indeholder også visse antistoffer, som kan forebygge en infektion med hepatitis A virus og parvovirus B19.
English: Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Danish: Undersøgelser af toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet hos dyr kan ikke gennemføres på grund af induktion af og interferens fra antistoffer, der udvikles til heterologe proteiner.
English: if you are allergic to immunoglobulins or to any other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for immunglobuliner eller et af de øvrige indholdsstoffer i KIOVIG (angivet i punkt 6).
English: In these rare cases, you may get allergic reactions such as a sudden fall in blood pressure or shock even if you have already received treatment with medicines containing antibodies in the past.
Danish: I disse sjældne tilfælde kan du få allergiske reaktioner som et pludseligt fald i blodtrykket eller shock, selv om du tidligere har fået behandling med lægemidler indeholdende antistoffer.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION/THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER/SÆRLIGE OMSTÆNDIGHEDER
English: Guillain Barré syndrome
Danish: Guillain Barré syndromet