FrancophonIA/ELRC3.0 huggingface dataset:
English: • Increase in serum creatinine level (a test which measures your kidney function) and/or acute renal failure (which signs are low back pain, fatigue, decrease in the amount of urine).
Danish: • Et forhøjet indhold af serumkreatinin (en test, der måler nyrefunktionen) og/eller pludseligt nyresvigt (hvor tegn er lændesmerter, træthed, nedsat mængde urin).
English: This medicine contains 50 mg of sorbitol per ml.
Danish: Dette lægemiddel indeholder 50 mg sorbitol pr. ml.
English: Do not store above 30 ºC.
Danish: Må ikke opbevares ved temperaturer over 30 ºC.
English: Do not use this medicine if you notice that the solution is cloudy or has deposits.
Danish: Brug ikke lægemidlet, hvis du bemærker, at opløsningen er uklar eller indeholder bundfald.
English: • Cases of transfusion related acute lung injury (TRALI) that causes hypoxia (lack of oxygen), dyspnoea (difficulty in breathing), tachypnoea (rapid breathing), cyanosis (lack of oxygen in the blood), fever and hypotension.
Danish: • Transfusionsrelateret akut lungeskade (TRALI), der forårsager hypoksi (oxygenmangel), dyspnø (vejrtrækningsbesvær), takypnø (hurtig vejrtrækning), cyanose (mangel på oxygen i blodet), feber og hypotension (lavt blodtryk).
English: Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, and patients with diseases which increase blood viscosity).
Danish: Der bør udvises forsigtighed ved ordination og infusion af IVIg til adipøse patienter, patienter med allerede eksisterende risikofaktorer for tromboemboliske episoder (fx høj alder, hypertension, diabetes mellitus eller tidligere vaskulære sygdomme eller tromboemboliske episoder, patienter med erhvervet eller medfødt trombofili, patienter med længerevarende immobilisering, patienter med svær hypovolæmi samt patienter med sygdomme, der øger blodviskositeten).
English: Arthralgia, Musculoskeletal discomfort Uncommon
Danish: Artralgi, muskuloskeletalt ubehag Ikke almindelig
English: 2.0 g/kg should be administered as a single dose.
Danish: Der bør gives 2,0 g/kg legemsvægt som enkeltdosis.
English: Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment.
Danish: Aseptisk meningitissyndrom er rapporteret i forbindelse med IVIg-behandling.
English: Immunomodulation: Primary immune thrombocytopenia
Danish: Immunmodulation: Primær immun trombocytopeni
English: ● red blood cells and white blood cells decreased
Danish: ● fald i antal røde og hvide blodceller
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Danish: Patienter, som oplever bivirkninger under behandlingen, bør vente med at føre motorkøretøj eller betjene maskiner, indtil bivirkningerne er ophørt.
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. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Danish: Undersøgelse af cerebrospinalvæsken er ofte positiv for pleocytose med op til adskillige tusinde celler pr. mm3, hovedsageligt forskellige typer granulocytter, og forhøjede proteinniveauer på op til adskillige hundrede mg/dl.
English: Therefore, IVIg recipients must be monitored for and IVIg infusion must be immediately stopped in case of pulmonary adverse reactions.
Danish: Derfor skal IVIg-modtagerne overvåges for lungebivirkninger, og IVIg-infusionen skal straks stoppes i tilfælde af sådanne.
English: Aseptic meningitis syndrome (AMS)
Danish: Aseptisk menigitissyndrom (AMS)
English: One ml contains 50 mg of D-sorbitol.
Danish: 1 ml indeholder 50 mg D-sorbitol.
English: ● urinary infection
Danish: ● urinvejsinfektion
English: For intravenous use
Danish: Til intravenøs anvendelse
English: Indication
Danish: Indikation
English: Frequency per infusion
Danish: Hyppighed pr. infusion
English: • dermatitis contact
Danish: • kontaktdermatitis
English: ● reticulocyte count increased
Danish: ● stigning i retikulocyttallet
English: • Patients with Secondary Immunodeficiency Syndromes (SID) with severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l (group 2)
Danish: • Patienter med sekundært immundefektsyndrom (SID) med svære eller tilbagevendende infektioner, ineffektiv antimikrobiel behandling og enten påvist specifikt antistofsvigt (PSAF)* eller serum-IgG-niveau på <4 g/l (gruppe 2)
English: Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising.
Danish: Blodplader spiller en vigtig rolle for blodets evne til at størkne, og et lavt antal kan medføre uønskede blødninger og blå mærker.
English: Side effects may be reduced by switching to Flebogamma DIF 50 mg/ml.
Danish: Risikoen for bivirkninger kan evt. reduceres, hvis der skiftes til Flebogamma DIF 50 mg/ml.
English: Special safety warning
Danish: Særlige advarsler angående sikkerhed
English: Insomnia, Restlessness
Danish: Søvnløshed, rastløshed
English: Diastolic hypotension, Hypotension
Danish: Diastolisk hypotension, hypotension
English: You must make up the infusion in exactly the way you have been shown in order to stop germs getting in. You must never self-administer it alone; a responsible adult must be always present.
Danish: Du skal klargøre infusionen på præcis den måde, som hospitalet har vist dig, så der ikke kommer bakterier ind. Du må aldrig tage infusionen alene.
English: The absence of mortality in the non-clinical studies performed with Flebogamma DIF with doses up to 2500 mg/kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system of the treated animals support the safety of Flebogamma DIF.
Danish: Sikkerheden ved Flebogamma DIF understøttes af, at der i de ikke-kliniske studier med Flebogamma DIF i doser på op til 2500 mg/kg legemsvægt ikke konstateredes mortalitet eller bekræftet relevante bivirkninger i åndedrætsorganer, kredsløb og centralnervesystem hos de behandlede dyr.
English: Cyanosis
Danish: Cyanose
English: Infusion related reaction
Danish: Infusionsrelateret reaktion
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Danish: Der er indberetninger om akut nyresvigt hos patienter i behandling med IVIg.
English: Abnormal behaviour
Danish: Unormal adfærd
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Danish: De implementerede forholdsregler anses for at være effektive mod kappebærende vira såsom humant immundefektvirus (HIV), hepatitis B-virus (HBV) og hepatitis C-virus (HCV) samt mod ikkekappebærende hepatitis A- og parvovirus B19-vira.
English: • (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
Danish: • (meget sjældent) tromboemboliske reaktioner, såsom myokardieinfarkt, apopleksi, lungeemboli,
English: ● tachycardia (acceleration of the heart activity)
Danish: ● acceleration af hjerteaktivitet (takykardi)
English: In a Post-authorisation Safety Study that included 66 patients, Flebogamma DIF 100 mg/ml showed a higher rate (18.46%, n=24/130) of infusions associated with potentially related adverse events than Flebogamma DIF 50 mg/ml (2.22%, n=3/135).
Danish: I et sikkerhedsstudie efter udstedelse af markedsføringstilladelse, der omfattede 66 patienter, udviste Flebogamma DIF 100 mg/ml en større hyppighed (18,46 %, n=24/130) af infusioner forbundet med potentielt relaterede bivirkninger end Flebogamma DIF 50 mg/ml (2,22 %, n=3/135).
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Danish: Efter intravenøs administration af humant normalt immunglobulin opnås omgående og fuldstændig biotilgængelighed i recipientens kredsløb.
English: The dose required to achieve a trough level of IgG of 6 g/l is of the order of 0.2 - 0.8 g/kg/month.
Danish: Den påkrævede dosis til opnåelse af en dalkoncentration af IgG på 6 g/l er i størrelsesordenen 0,2 - 0,8 g/kg/måned.
English: - If you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.
Danish: - Hvis du ikke har tilstrækkeligt immunglobulin af typen IgA i blodet eller har udviklet IgA-antistoffer.
English: The most reported post-marketing ADRs received since the product was authorised for both concentrations were chest pain, flushing, blood pressure increased and decreased, malaise, dyspnoea, nausea, vomiting, pyrexia, back pain, headache and chills.
Danish: De hyppigst rapporterede bivirkninger efter markedsføring, efter begge koncentrationer var godkendt, var brystsmerter, ansigtsrødme, blodtryksstigning og blodtryksfald, utilpashed, dyspnø, kvalme, opkastning, pyreksi, rygsmerter, hovedpine og kulderystelser.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 g / 10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,5 g / 10 ml
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Instituto Grifols, S.A.
English: Human normal immunoglobulin (IVIg)
Danish: Humant normalt immunglobulin (IVIg)
English: ● fever (body temperature increased)
Danish: ● øget kropstemperatur (feber)
English: It is strongly recommended that every time you receive a dose of Flebogamma DIF, the name and batch number of the medicine (stated on the label and carton after Lot) are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt at notere lægemidlets batchnummer og navn (angivet på etiketten og kartonen efter Lot), hver gang du får en dosis Flebogamma DIF, så du får et register over de anvendte batcher.
English: Post-authorisation Safety Study
Danish: Sikkerhedsstudie efter udstedelse af markedsføringstilladelse
English:  You should avoid the concomitant use of medicines that increase the excretion of water from your body (loop diuretics) during treatment with Flebogamma DIF.
Danish: • Du bør undgå samtidig brug af lægemidler med vanddrivende virkning (slyngediuretika) under behandlingen med Flebogamma DIF.
English: The following dosage regimens are given as a guideline.
Danish: De følgende doseringsregimer er vejledende.
English: If the patient tolerates the infusion well, additional increments of 0.02 ml/kg/min may be made at 30-minute intervals up to a maximum of 0.08 ml/kg/min.
Danish: Hvis patienten tåler infusionen, kan yderligere øgninger på 0,02 ml/kg/min foretages med 30-minutters intervaller op til maksimalt 0,08 ml/kg/min.
English: Infusion reaction
Danish: Infusionsreaktion
English: In persons more than 2 years old with HFI, a spontaneous aversion for fructose-containing foods develops and may be combined with the onset of symptoms (vomiting, gastro-intestinal disorders, apathy, height and weight retardation).
Danish: Hos personer over 2 år med HFI udvikles en spontan aversion for fructose-indeholdende mad, og den kan kombineres med fremkomst af symptomer (opkastning, mave-tarm-problemer, apati, vækst- og vægthæmning).
English: For patients experiencing adverse reactions, it is advisable to reduce the infusion rate in subsequent infusions and limit the maximum rate to 0.04 ml/kg/min, or administer IVIg at a 5% concentration.
Danish: For patienter, der oplever bivirkninger, er det tilrådeligt at reducere infusionshastigheden i efterfølgende infusioner og begrænse den maksimale hastighed til 0,04 ml/kg/min, eller indgive IVIg i en 5 % koncentration.
English: • abnormal behaviour
Danish: • unormal adfærd
English: • cases of Transfusion Related Acute Lung Injury (TRALI)
Danish: • tilfælde af transfusionsrelateret akut lungeskade (TRALI)
English: It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.
Danish: De kan især optræde, hvis du ikke har nok immunglobulin af typen IgA i blodet eller har udviklet antistoffer mod IgA.
English: It is strongly recommended that every time that Flebogamma DIF 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 kraftigt at notere batchnummer og præparatnavn, hver gang Flebogamma DIF gives til en patient, så man således registrerer forbindelsen mellem patienten og den pågældende batch.
English: Infections and infestations Influenza, Meningitis aseptic, Urinary tract infection
Danish: Influenza, aseptisk meningitis, urinvejsinfektion
English: ● anorexia (lack of appetite)
Danish: ● appetitløshed (anoreksi)
English: • Thromboembolic reactions such as myocardial infarction (tight band around the chest with feeling like your heart is beating too fast), stroke (muscle weakness in the face, arm, or leg, trouble speaking or understanding others who are speaking), pulmonary embolism (shortness of breath, chest pain and fatigue), deep vein thromboses (pain and swelling in an extremity).
Danish: • Blodprop-reaktioner såsom blodprop i hjertet (stramt bælte om brystet med en følelse af, at dit hjerte banker for hurtigt), slagtilfælde (muskelsvaghed i ansigt, arm eller ben, talebesvær eller problemer med at forstå andre, når de taler), blodprop i lungerne (stakåndethed, brystsmerter og træthed), blodprop i de dybtliggende vener (smerter og hævelse i et af lemmerne).
English: Additional side effects in children and adolescents
Danish: Hos børn og unge kan endvidere ses følgende bivirkninger
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 Coomb's test).
Danish: Passiv overførsel af antistoffer til røde blodlegemers antigener, fx A, B, D, kan interferere med nogle serologiske test af røde blodlegemers antistoffer, fx direkte antiglobulin-test (DAT, direkte Coombs test).
English: The recommended infusion rate given under section 4.2 must be closely followed.
Danish: 4.2 skal følges nøje.
English: IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coomb's test) and, rarely, haemolysis.
Danish: IVIg-præparater kan indeholde blodtype-antistoffer, der kan fungere som hæmolysiner og inducere in vivo coating af røde blodlegemer med immunglobulin, hvilket fører til en positiv direkte antiglobulinreaktion (Coombs test) og i sjældne tilfælde hæmolyse.
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: Det er særligt vigtigt, at patienter, som ikke tidligere har modtaget humant normalt immunglobulin, som skifter fra et andet IVIg-præparat, eller som har haft en længere pause siden forrige infusion, monitoreres på hospitalet under den første infusion og i den første time derefter, så tegn på eventuelle bivirkninger opdages.
English: Frequency of injections
Danish: Injektionsfrekvens
English: No evidence is available to require a dose adjustment.
Danish: Nedsat leverfunktion Der foreligger ikke evidens for at kræve en dosisjustering.
English: • urinary retention
Danish: • urinretention
English: • alanine aminotransferase (hepatic transaminase) increased
Danish: • forhøjet alaninaminotransferase (levertransaminase)
English: • in case of high rate of infusion
Danish: • ved høj infusionshastighed
English: ● infusion related reaction and infusion site reaction (including infusion site erythema and infusion site pain)
Danish: ● infusionsrelateret reaktion og reaktion på infusionsstedet (herunder rødme og smerter på infusionsstedet)
English: Starting dose: 2 g/kg
Danish: Startdosis: 2 g/kg legemsvægt
English: IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Danish: IVIg-modtagere skal monitoreres for kliniske tegn og symptomer på hæmolyse (se pkt.
English: No dose adjustment unless clinically warranted, see section 4.4.
Danish: Nedsat nyrefunktion Ingen dosisjustering medmindre det er klinisk nødvendigt, se pkt.
English: ● photophobia (excessive sensitivity to light)
Danish: ● stærk følsomhed over for lys (fotofobi)
English: Acne, Alopecia, Ecchymosis, Erythema, Hyperhidrosis, Palmar erythema, Purpura
Danish: Akne, alopeci, ekkymose, erytem, hyperhidrose, palmar erytem, purpura Ikke almindelig
English: - The active substance is human normal immunoglobulin (IVIg).
Danish: - Aktivt stof: humant normalt immunglobulin (IVIg).
English: Source of the safety database from clinical trials and post-authorisation safety studies in a total of 160 patients exposed to Flebogamma DIF 100 mg/ml (with a total of 915 infusions)
Danish: Kilde er sikkerhedsdatabasen fra kliniske studier og sikkerhedsstudier efter markedsføring hos i alt 160 patienter eksponeret for Flebogamma DIF 100 mg/ml (med i alt 915 infusioner)
English: Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Danish: Fordeling af IgG-underklasser (cirkaværdier): IgG1
English: Diastolic hypertension, Hypertension
Danish: Diastolisk hypertension, hypertension
English: Blood pressure diastolic decreased, Blood pressure increased, Blood pressure systolic increased, Heart rate increased
Danish: Fald i diastolisk blodtryk, stigning i blodtryk, stigning i systolisk blodtryk, øget hjertefrekvens
English: In persons more than 2 years old with problems to tolerate fructose, a spontaneous reaction for fructose-containing foods develops which may have the following symptoms: vomiting, gastro-intestinal disorders, apathy, height and weight retardation.
Danish: Hos personer over 2 år med problemer med at tolerere fructose udvikles en spontan reaktion for fructose-indeholdende mad, og der kan være de følgende symptomer: opkastning, mavetarm-problemer, apati, vækst- og vægthæmning).
English: Flebogamma DIF contains sorbitol
Danish: Flebogamma DIF indeholder sorbitol
English: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing limb weakness, numbness, pain and fatigue.
Danish: • Kronisk inflammatorisk demyelinerende polyradikuloneuropati (CIDP), en sjælden og tiltagende sygdom, der forårsager svaghed, følelsesløshed, smerter og træthed i lemmerne.
English: Starting dose: 2 g/kg divided over 2 - 5 consecutive days.
Danish: Startdosis: 2 g/kg fordelt over 2-5 på hinanden følgende dage.
English: Source of the safety database from clinical trials and post-authorisation safety studies in a total of 128 patients exposed to Flebogamma DIF 50 mg/ml (with a total of 1318 infusions)
Danish: Kilde er sikkerhedsdatabasen fra kliniske studier og sikkerhedsstudier efter markedsføring hos i alt 128 patienter eksponeret for Flebogamma DIF 50 mg/ml (med i alt 1.318 infusioner)
English: The dose interval when steady state has been reached varies from 3 - 4 weeks.
Danish: Efter opnåelse af ligevægt varierer dosisintervallet fra 3 til 4 uger.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget for krav om brailleskrift.
English: OTHER To hang pull here
Danish: ANDET Træk her for ophængning.
English: Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Danish: Vedligeholdelsesdosis: 1 g/kg hver 2. til 4. uge eller 2 g/kg hver 4. til 8. uge.
English: Three clinical trials were performed with Flebogamma DIF, two for replacement therapy in patients with primary immunodeficiency (one in both adults and in children above 10 years and another in children between 2 to 16 years) and another for immunomodulation in adult patients with immune thrombocytopenic purpura.
Danish: Der er udført tre kliniske forsøg med Flebogamma DIF, to vedrørende substitutionsterapi til patienter med primær immundefekt (ét med både voksne og børn over 10 år og et andet med børn i alderen 2-16 år) og ét vedrørende immunmodulation hos voksne med idiopatisk trombocytopenisk purpura.
English: • A sudden fall in blood pressure and, in isolated cases, anaphylactic shock (which signs are rash, hypotension, palpitation, wheezing, coughing, sneezing and difficulty breathing among others), even if you have shown no hypersensitivity to previous administration.
Danish: • Et pludseligt blodtryksfald og i enkeltstående tilfælde anafylaktisk shock (hvor tegn blandt andet er udslæt, lavt blodtryk, hjertebanken, hvæsende vejrtrækning, hoste, nysen og vejrtrækningsbesvær), også selvom du ikke har vist overfølsomhed ved tidligere infusioner.
English: The solution should be clear or slightly opalescent.
Danish: Opløsningen bør være klar eller let opaliserende.
English: Flebogamma DIF 50 mg/ml has a half-life of about 30 - 32 days.
Danish: Flebogamma DIF 50 mg/ml har en halveringstid på 30 til 32 dage.
English: Do not use Flebogamma DIF
Danish: Brug ikke Flebogamma DIF
English: Dermatitis contact, Hyperhidrosis, Rash
Danish: Kontaktdermatitis, hyperhidrose, udslæt
English: Transfusion related acute lung injury (TRALI)
Danish: Transfusionsrelateret akut lungeskade (TRALI)
English: The recommended starting dose is 0.4 - 0.8 g/kg given once followed by at least 0.2 g/kg given every three to four weeks.
Danish: Anbefalet startdosis er 0,4 - 0,8 g/kg legemsvægt én gang efterfulgt af mindst 0,2 g/kg legemsvægt hver 3. til 4. uge.
English: Flebogamma DIF 100 mg/ml has a half-life of about 34 - 37 days.
Danish: Flebogamma DIF 100 mg/ml har en halveringstid på 34-37 dage.
English: Three clinical trials were performed with Flebogamma DIF, one for replacement therapy in patients with primary immunodeficiency (in both adults and in children above 6 years) and two for immunomodulation, in patients with immune thrombocytopenic purpura (one in adult patients and another in both adults and in children between 3 and 16 years).
Danish: Der er udført tre kliniske forsøg med Flebogamma DIF, et vedrørende substitutionsterapi til patienter med primær immundefekt (med både voksne og børn over 6 år) og to vedrørende immunmodulation, hos patienter med idiopatisk trombocytopenisk purpura (ét med voksne patienter og et andet med både voksne og børn i alderen 3-16 år).
English: Kawasaki disease
Danish: Kawasakis syndrom
English: Certain adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion.
Danish: Visse bivirkninger (fx hovedpine, rødme, kulderystelser, myalgi, hvæsende vejrtrækning, takykardi, lændesmerter, kvalme og hypotension) kan være relateret til infusionshastigheden.
English: Systolic hypertension
Danish: Systolisk hypertension
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse
English: A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/µl) although it did not reach normal levels.
Danish: I et klinisk forsøg med kroniske ITP-patienter opnåedes en signifikant stigning i det mediane trombocyttal (64.000/µl).