FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Danish: På grund af mangel på sammenligningsstudier må dette lægemiddel ikke blandes med andre lægemidler eller andre IVIg-produkter.
English: There are no theoretical or observed differences in the action of immunoglobulins in children compared to adults.
Danish: Der er ingen teoretiske eller observerede forskelle mellem immunglobuliners virkning hos børn og voksne.
English: Therefore, IVIg recipients must be monitored for and IVIg infusion must be immediately stopped in case of pulmonary adverse reactions.
Danish: IVIg-modtagere skal derfor overvåges og IVIg-infusion skal straks afbrydes i tilfælde af en uønsket lungereaktion.
English: Although KIOVIG does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which could affect your blood sugar level.
Danish: Selv om KIOVIG ikke indeholder sukker, kan det fortyndes med en speciel sukkeropløsning (5 % glucose), der kan påvirke dit blodsukkerniveau.
English: Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Danish: Overfølsomhed over for humane immunglobuliner, særligt hos patienter med antistoffer mod IgA.
English: What you need to know before you use KIOVIG
Danish: Det skal du vide, før du begynder at bruge KIOVIG
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.
Danish: Tilfælde af reversibel aseptisk meningitis og sjældne tilfælde af forbigående hudreaktioner (herunder kutan lupus erythematosus - hyppighed er ikke kendt) er blevet iagttaget med humant normalt immunglobulin.
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 smitsomme stoffer.
English: At the beginning of your infusion you will receive KIOVIG at a slow rate.
Danish: Ved infusionens begyndelse får du KIOVIG med lav hastighed.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillerne af disse produkter inddrager trin i behandlingen af blodet eller plasmaet, der kan inaktivere eller fjerne vira.
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02
Danish: Farmakoterapeutisk klassifikation: immunsera og immunglobuliner: immunglobuliner, normale humane, til intravaskulær brug, ATC-kode: J06BA02
English: • Your doctor will also take special care if you have or had previously problems with your kidneys, or if you receive medicinal products that may harm your kidney (nephrotoxic medicinal products), as there is a very rare chance of acute kidney failure.
Danish: • Din læge vil også tage speciel hensyn til, hvis du har eller tidligere havde problemer med dine nyrer, eller hvis du får lægemidler, som kan skade dine nyrer (nefrotoksiske lægemidler), da der er en meget lille risiko for akut nyresvigt.
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.5 ml/kg BW/hr); - are carefully monitored for any symptoms throughout the infusion period.
Danish: Eventuelle komplikationer kan ofte undgås ved at sørge for, at patienterne: - ikke er overfølsomme for humant normalt immunglobulin ved først at injicere præparatet langsomt (0,5 ml/kg kropsvægt/time); - overvåges omhyggeligt for symptomer gennem hele infusionsperioden.
English: Congenital AIDS
Danish: Medfødt aids
English: If dilution to lower concentrations is required, immediate use after dilution is recommended.
Danish: Hvis fortynding til lavere koncentrationer er nødvendig, anbefales omgående anvendelse efter fortynding.
English: There is reassuring clinical experience regarding the lack of hepatitis A or Parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Danish: Der er beroligende klinisk erfaring med hensyn til manglende overførsel af hepatitis A eller Parvovirus B19 med immunglobuliner, og det antages også, at antistofindholdet bidrager i væsentlig grad til den virale sikkerhed.
English: In patients at risk, the use of IVIg products that do not contain these excipients may be considered.
Danish: Hos patienter, der er udsat for risiko, kan det overvejes at anvende IVIg-produkter, der ikke indeholder disse hjælpestoffer.
English: Hyperproteinemia, increased serum viscosity and subsequent relative pseudohyponatremia may occur in patients receiving IVIg therapy.
Danish: Hyperproteinæmi, øget serumviskositet samt efterfølgende relativ pseudohyponatriæmi kan opstå hos patienter, der får IVIg-behandling.
English: Vertigo, fluid in middle ear
Danish: Vertigo, væske i mellemøret
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Disse forholdsregler omfatter en omhyggelig udvælgelse af blod- og plasmadonorer, så man sikrer, at donorer med risiko for at have infektioner udelukkes, samt testning af hver bloddonation og plasmapools for tegn på virus/infektioner.
English: After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Danish: Efter indgivelse af dette præparat skal der være et interval på 3 måneder inden vaccinering med levende svækkede virusvacciner.
English: What KIOVIG contains
Danish: KIOVIG indeholder
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Danish: Det har en fordeling af immunglobulin G-underklasser, der er nært proportional med den, der findes i normalt humant plasma.
English: Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs.
Danish: Tabel 1 viser bivirkninger fra kliniske studier, og tabel 2 viser bivirkninger efter markedsføring.
English: Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA containing product can result in anaphylaxis.
Danish: Patienter med selektiv IgA-mangel, som udviklede antistoffer til IgA, da indgivelse af et produkt, der indeholder IGA, kan medføre anafylaksi.
English: Patients who do not have enough blood platelets (primary immune thrombocytopenia, ITP), and who are at high risk of bleeding or will have surgery in the near future.
Danish: Patienter, som ikke har nok blodplader (primær immun trombocytopeni, ITP), og som er udsat for en stor risiko for blødning, eller som skal opereres i nær fremtid.
English: Solutions that are cloudy or have deposits should not be used.
Danish: Opløsninger, der er grumsede eller indeholder bundfald, må ikke anvendes.
English: • It is recommended that every time KIOVIG is administered, the name and batch number of the product is recorded.
Danish: • Det anbefales, at hver gang KIOVIG indgives, noteres navn og batch nummer på præparatet.
English: Depending on your doctor's decision the rate of infusion can be slowed or the infusion can be stopped altogether.
Danish: Afhængig af din læges beslutning kan infusionshastigheden nedsættes eller infusionen helt standses.
English: 0.8-1 g/kg or
Danish: 0,8-1 g/kg eller
English: • with undetectable IgA who have anti-IgA antibodies
Danish: • med ikke-målbart IgA, som har anti-IgA-antistoffer
English: Treatment of patients who do not have sufficient antibodies (replacement therapy).
Danish: Behandling af patienter, som ikke har antistoffer nok (erstatningsbehandling).
English: Patients may experience reactions (for example dizziness or nausea) during the treatment with KIOVIG, which might affect the ability to drive and use machines.
Danish: Patienter kan opleve bivirkninger (f.eks. svimmelhed eller kvalme) under behandling med KIOVIG, der kan påvirke evnen til at køre bil eller til at arbejde med værktøj eller maskiner.
English: • who had tolerated previous treatment with human normal immunoglobulin
Danish: • som tidligere har tålt behandling med normalt humant immunglobulin
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 til røde blodlegemers antigener, f.eks. A, B, D, kan påvirke nogle serologiske tests af røde blodlegemers antistoffer, for eksempel direkte antiglobulin-test (DAT, direkte Coombs' test).
English: Hypotension, deep vein thrombosis
Danish: Hypotension, dyb venetrombose
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Danish: Især patienter, der er behandlingsnaive over for humant normalt immunglobulin, patienter, der skifter fra et alternativt IVIg-produkt, eller når der har været et langt interval efter den forrige infusion, bør overvåges på hospitalet under den første infusion og i den første time efter den første infusion, så man opfanger eventuelle uønskede signaler.
English: 2 g/kg should be administered as a single dose.
Danish: Kawasakis sygdom2 g/kg bør indgives som en enkelt dosis.
English: 2 g/kg in one dose in association with acetylsalicylic acid
Danish: Kawasakis sygdom2 g/kg i én dosis kombineret med acetylsalicylsyre
English: *CI - Confidence Interval
Danish: *CI - Konfidensinterval
English: In case of renal impairment, IVIg discontinuation should be considered.
Danish: I tilfælde af nyreskade bør det overvejes at ophøre med IVIg.
English: In patients receiving IVIg, there have been reports of acute non-cardiogenic pulmonary edema (Transfusion Related Acute Lung Injury, (TRALI) in patients administered IVIg (including KIOVIG).
Danish: Hos patienter, der får IVIg, er der rapporteret akut non-kardiogent lungeødem (ransfusionsrelateret akut lungeskade, (TRALI) hos patienter, der får IVIg (herunder KIOVIG).
English: In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products, age over 65, sepsis, hyperviscosity or paraproteinemia.
Danish: I de fleste tilfælde har man identificeret risikofaktorer, såsom allerede eksisterende nyreinsufficiens, diabetes mellitus, hypovolæmi, overvægt, ledsagende nefrotoksiske lægemidler, en alder på over 65, sepsis, hyperviskositet eller paraproteinæmi.
English: Insomnia, anxiety
Danish: Søvnløshed, angst
English: Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Danish: I sjældne tilfælde kan humane normale immunglobuliner forårsage et pludseligt fald i blodtrykket og, i isolerede tilfælde, anafylaktisk shock, selv om patienten ikke har vist nogen overfølsomhed ved tidligere indgivelse.
English: You may have to wait for up to 1 year after receiving immunoglobulins before you receive your measles vaccine.
Danish: Du skal muligvis vente i op til 1 år efter at have fået immunglobuliner, før du kan få din mæslingevaccine.
English: Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease).
Danish: Patienter med en sygdom, der forårsager mange betændelser i adskillige af kroppens organer (Kawasakis sygdom).
English: Patients with a disease that is associated with multiple inflammations of the nerves in the whole body (Guillain Barré syndrome).
Danish: Patienter med en sygdom, som er forbundet med mange betændelser i nerverne i hele kroppen (Guillian Barré syndrome).
English: Summary of KIOVIG pharmacokinetic parameters
Danish: Sammendrag af farmakokinetiske parametre for KIOVIG
English: Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr.
Danish: Kliniske data opnået med et begrænset antal patienter indikerer også, at voksne PID patienter kan tolerere en infusionshastighed på op til 8 ml/kg kropsvægt/time.
English: Patients with inborn lack of antibody production (primary immunodeficiency syndromes).
Danish: Patienter med medfødt manglende produktion af antistoffer (primære immundefekt-syndromer).
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Danish: Tilfælde af akut nyresvigt er rapporteret hos patienter, der får IVIg-terapi.
English: TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension.
Danish: TRALI er karakteriseret ved alvorlig hypoxi, dyspnø, takypnø, cyanose, feber og hypotension.
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4 ).
Danish: Overdosering kan medføre overhydrering og hyperviskositet, særlig hos patienter, der er udsat for risiko, herunder ældre patienter eller patienter med hjerte- eller nyreskader (se pkt.
English: However, medicines that contain antibodies have been used in pregnant or breast-feeding women, and it has been shown that there are no harmful effects on the course of pregnancy or the baby to be expected.
Danish: Imidlertid har medicin indeholdende antistoffer været anvendt til gravide eller ammende kvinder, og det er blevet påvist, at der ikke kan forventes skadelige virkninger på spædbarnet.
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Danish: Klinisk erfaring med immunglobuliner antyder, at der ikke forventes skadelige virkninger på fertilitet.
English: • 1 ml of KIOVIG contains 100 mg of human protein of which at least 98% is immunoglobulin G (IgG).
Danish: • 1 ml KIOVIG indeholder 100 mg humant protein, hvoraf mindst 98 % er immunglobulin G (IgG).
English: Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Danish: De forholdsregler, der er truffet, betragtes som effektive mod enveloped vira som HIV, HBV og HCV samt mod de non-enveloped vira HAV og Parvovirus B19.
English: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/L.
Danish: Doseringen bør nå op på IgG-dalkoncentration (målt inden den næste infusion) på mindst 5-6 g/L.
English: Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Danish: Meget sjældent: Tromboemboliske reaktioner som myokardieinfarkt, slagtilfælde, pulmonal emboli og dybe venetromboser.
English: • The active substance of KIOVIG is human normal immunoglobulin.
Danish: • Aktivt stof i KIOVIG: Humant normalt immunglobulin.
English: 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Danish: 0,4 g/kg/dag over 5 dage (mulig gentagelse af dosering i tilfælde af tilbagefald).
English: • KIOVIG must only be administered intravenously.
Danish: • KIOVIG må kun indgives intravenøst.
English: Marketing Authorisation Holder Takeda Manufacturing Austria AG Industriestrasse 67
Danish: Indehaver af markedsføringstilladelsen og fremstiller Takeda Manufacturing Austria AG Industriestrasse 67
English: The same indications, dose and frequency of infusion as for adults apply for children and adolescents (age 0 to 18).
Danish: Der gælder de samme indikationer, dosis og infusionshyppighed som for voksne til børn og teenagere (0-18 år).
English: Incremental recovery (mg/dl)/(mg/kg)
Danish: Inkrementel recovery (mg/dl)/(mg/kg)
English: Human normal immunoglobulin ……………100 mg (purity of at least 98% IgG)
Danish: Humant normalt immunglobulin ……………100 mg (renhed på mindst 98 % IgG)
English: • avoidance of concomitant use of loop diuretics (see 4.5).
Danish: • at samtidig brug af loop-diuretika undgås (se 4.5).
English: Certain side effects, e.g. headache or flushing, may be reduced by slowing the infusion rate.
Danish: Visse bivirkninger, f.eks. hovedpine eller rødmen, kan reduceres ved at nedsætte infusionshastigheden.
English: Patients who suffer from a rare condition characterized by slow progressive asymmetrical weakness of limbs without sensory loss (multifocal motor neuropathy, MMN).
Danish: Patienter, der lider af en sjælden sygdom, der er kendetegnet ved langsomt fremadskridende asymmetrisk svækkelse af ben og arme uden tab af følesans (multifokal motorisk neuropati, MMN).
English: KIOVIG should only be administered intravenously.
Danish: KIOVIG må kun indgives intravenøst.
English: Each vial of 10 ml contains: 1 g of human normal immunoglobulin Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Danish: Hvert hætteglas på 10 ml indeholder: 1 g humant normalt immunglobulin Hvert hætteglas på 25 ml indeholder: 2,5 g humant normalt immunglobulin Hvert hætteglas på 50 ml indeholder: 5 g humant normalt immunglobulin Hvert hætteglas på 100 ml indeholder: 10 g humant normalt immunglobulin Hvert hætteglas på 200 ml indeholder: 20 g humant normalt immunglobulin Hvert hætteglas på 300 ml indeholder: 30 g humant normalt immunglobulin
English: No dose adjustment unless clinically warranted, see section 4.4.
Danish: Ingen dosisjustering medmindre det er klinisk påkrævet, se pkt.
English: Treatment of patients with certain inflammatory disorders (immunomodulation).
Danish: Behandling af patienter med bestemte inflammatoriske lidelser (immunmodulation).
English: If you have received a vaccination during the last six weeks and up to three months, the infusion of immunoglobulins like KIOVIG may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox.
Danish: Hvis du har fået en vaccination inden for de seneste seks uger og op til tre måneder, kan infusion af immunglobuliner som KIOVIG skade virkningen af nogle levende virusvacciner som mæslinge-, røde hunde-, fåresyge- og skoldkoppevaccine.
English: Immunoglobulins are normal constituents of the human body.
Danish: Immunglobuliner er normale bestanddele af menneskets krop.
English: In these conditions, immunoglobulins may increase the risk of cardiac infarction, stroke, lung embolism, or deep vein thrombosis, although only in very rare cases.
Danish: Under disse omstændigheder kan immunglobuliner øge risikoen for hjerteinfarkt, slagtilfælde, lungeemboli, nyreskade eller dyb venetrombose, dog kun i meget sjældne tilfælde.
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Danish: Humant normalt immunglobulin er efter intravenøs indgivelse øjeblikkeligt og fuldstændigt biotilgængeligt i modtagerens kredsløb.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Yderligere oplysninger om KIOVIG findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Danish: • Primær immun trombocytopeni (ITP) hos patienter med høj risiko for blødning eller forud for operation for at korrigere trombocyttallet.
English: • Do not use this medicine if you notice particulate matter or discolouration.
Danish: • Brug ikke lægemidlet, hvis der iagttages småpartikler eller misfarvning.
English: Human protein, 100 mg/ml, at least 98% is IgG.
Danish: Humant protein, 100 mg/ml, mindst 98 % er IgG.
English: The dose required to achieve a trough level of 5-6 g/L is of the order of 0.2-0.8 g/kg/month.
Danish: Den nødvendige dosis for at opnå en dalkoncentration på 5-6 g/l er i størrelsesordenen 0,2-0,8 g/kg/måned.
English: IVIg products can contain blood group antibodies that may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Danish: IVIg-produkter kan indeholde blodtype-antistoffer, der fungerer som hæmolysiner og inducerer in vivo coating af røde blodlegemer med immunglobulin, hvilket fører til en positiv direkte antiglobulinreaktion (Coombs' test) og i sjældne tilfælde hæmolyse.
English: *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Danish: *PSAF = kan ikke opstille mindst en fordoblet stigning i lgG antistoftiter til pneumokokpolysaccharidog polypeptidantigenvacciner
English: Hypogammaglobulinaemia (<4 g/l) in patients after allogeneic haematopoietic stem cell transplantation
Danish: Hypogammaglobulinæmi (< 4 g/l) hos patienter efter allogen hæmatopoietisk stamcelletransplantation
English: If dilution of KIOVIG to lower concentrations is required for patients suffering from diabetes mellitus, the use of 5% glucose solution for dilution may have to be reconsidered.
Danish: Hvis fortynding af KIOVIG til lavere koncentrationer er nødvendig hos patienter, der lider af diabetes mellitus, skal anvendelse af 5 % glucoseinfusionsvæske til fortynding måske genovervejes.
English: If well tolerated, the rate of administration may gradually be increased to a maximum of 6 ml/kg bodyweight/hour.
Danish: Hvis dette tolereres godt, kan indgivelseshastigheden gradvist forøges til maksimalt 6 ml/kg kropvægt/time.
English: • The product must be brought to room or body temperature before use.
Danish: • Produktet skal have stuetemperatur eller kropstemperatur før anvendelsen.
English: It is strongly recommended that every time that KIOVIG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Danish: Det anbefales indtrængende at notere navn og batchnummer på præparatet, hver gang KIOVIG indgives i en patient, så der opretholdes en forbindelse mellem patienten og det pågældende batch af præparatet.
English: Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS and recurrent bacterial infections
Danish: Hypogammaglobulinæmi og recidiverende bakterieinfektioner hos patienter med kronisk lymfatisk leukæmi, hvor forebyggende antibiotika ikke har virket; Hypogammaglobulinæmi og recidiverende bakterieinfektioner hos patienter med multiple myeloma i plateaufasen, som ikke har reageret på immunisering med pneumokokker; aids og recidiverende bakterieinfektioner.
English: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Danish: Immunglobuliner udskilles i mælken og kan måske bidrage til at beskytte den nyfødte mod patogener, der kan trænge ind via slimhinderne.