FrancophonIA/ELRC3.0 huggingface dataset:
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Danish: Det kan være nødvendigt at justere doseringen og intervallerne i henhold til det individuelle sygdomsforløb.
English: Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.
Danish: Cyanose (iltmangel i blodet) blev rapporteret hos et barn, men ikke hos voksne.
English: - The other ingredients are sorbitol and water for injections (see section 2 for further information about ingredients).
Danish: - Øvrige indholdsstoffer er sorbitol og vand til injektionsvæsker (se punkt 2 for yderligere oplysninger om indholdsstofferne).
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Danish: Dalkoncentrationen af IgG bør måles og vurderes i relation til infektionsincidensen.
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 administration, ATC-kode: J06BA02.
English: In patients at risk, the use of IVIg products that do not contain these excipients may be considered.
Danish: Hos risikopatienter kan det overvejes at anvende IVIgpræparater, der ikke indeholder disse hjælpestoffer.
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 lægemiddel bør der gå mindst 3 måneder inden vaccination med vacciner indeholdende levende svækket virus.
English:  Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish:  Fortæl det altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Dose based on body weight may require adjustment in underweight or overweight patients.
Danish: Dosis baseret på legemsvægt kan kræve justering hos undervægtige eller overvægtige patienter.
English: While 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: Indberetninger om nedsat nyrefunktion og akut nyresvigt er blevet forbundet med brug af mange af de godkendte IVIg-præparater indeholdende forskellige hjælpestoffer som saccharose, glucose og maltose, men de, der indeholder saccharose som stabilisator, tegnede sig for en uforholdsmæssig stor andel af det samlede antal indberetninger.
English: 6.6 Special precautions for disposal and other handling The product should be brought to room or body temperature before use.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Lægemidlet bør have stue- eller legemstemperatur før brug.
English: Patients may experience reactions (for example dizziness or nausea) during treatment, which might affect the ability to drive and use machines.
Danish: Patienter kan opleve reaktioner (fx svimmelhed eller kvalme) i løbet af behandlingen, hvilket kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Flebogamma DIF is given by injection into your veins (intravenous administration).
Danish: Flebogamma DIF gives gennem indsprøjtning i venerne (intravenøs administration).
English: No negative effects on the breastfed newborns/infants are anticipated.
Danish: Der forventes ingen negative virkninger hos nyfødte/spædbørn, der ammes.
English: After the administration 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 administration af immunglobulin kan en forbigående stigning i passivt overførte antistoffer i patientens blod resultere i falsk positive resultater af serologiske tests.
English: However one subject treated with Flebogamma DIF 100 mg/ml presented mild episodes of headache in all infusions and one more patient had 2 episodes of pyrexia in 2 infusions.
Danish: Imidlertid havde en forsøgsperson, der fik Flebogamma DIF 100 mg/ml, lette episoder med hovedpine under alle infusioner, og en anden patient havde 2 episoder med pyreksi under 2 infusioner.
English: Vital signs (body temperature, blood pressure, heart rate and respiratory rate) should be observed during the infusion of Flebogamma DIF.
Danish: Vitale tegn (legemstemperatur, blodtryk, puls og vejrtrækning) skal observeres under infusionen af Flebogamma DIF.
English: The safety results for 4 paediatric patients (those ≤ 17 years old) included in the PID study and the results for the 13 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Danish: Sikkerhedsresultaterne for 4 pædiatriske patienter (≤ 17 år), der var inkluderet i PID-studiet, samt resultaterne for de 13 børn (i alderen 3 til 16 år), der var inkluderet i ITP-studiet, blev evalueret.
English: The dose may need to be individualised for each patient dependent on the clinical response.
Danish: Der kan være behov for individuel dosering til den enkelte patient afhængigt af det kliniske respons.
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 smitstoffer.
English: There were no other subjects with more than 1 infusion with adverse reactions in both groups.
Danish: Der var ingen andre forsøgspersoner i de to grupper, der havde mere end 1 infusion med bivirkninger.
English: • reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
Danish: • reversible hæmolytiske reaktioner, især hos patienter med blodtype A, B og AB, og (sjældent)
English: In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
Danish: Hvis der opstår en bivirkning, skal enten administrationshastigheden reduceres eller infusionen stoppes.
English: Very common (may affect more than 1 in 10 infusions): ● headache
Danish: Meget almindelig (kan forekomme ved flere end 1 ud af 10 infusioner): ● hovedpine
English: • Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced.
Danish: • Primær immun trombocytopeni (ITP), en tilstand hvor antallet af blodplader er stærkt nedsat.
English: ● meningitis aseptic (non-infective meningitis)
Danish: ● aseptisk meningitis (ikke-infektiøs meningitis)
English: This applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også nye eller hidtil ukendte vira og andre typer infektioner.
English: Treatment of adults, children and adolescents (2 - 18 years) with certain autoimmune disorders (immunomodulation).
Danish: Behandling af voksne, børn og unge (2-18 år) med visse autoimmune sygdomme (immunmodulation).
English: • Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies (group 1)
Danish: • Patienter med primært immundefektsyndrom (PID), en medfødt mangel på antistoffer (gruppe 1)
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Danish: • test af hver enkelt bloddonation og plasmagruppe for tegn på virus/infektioner.
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 doseringen i tilfælde af recidiv).
English: • cases of reversible aseptic meningitis
Danish: • tilfælde af reversibel aseptisk meningitis
English: The dose recommendations are summarised in the following table:
Danish: Dosisanbefalingerne er opsummeret i nedenstående tabel:
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP. Do not store above 30 ºC.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten efter EXP.
English: The posology in children and adolescents (2 - 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 til børn og unge (2-18 år) er ikke forskellig fra dosering til voksne, da doseringen for hver indikation gives efter kropsvægt og justeres efter det kliniske resultat for ovennævnte tilstande.
English: In case of renal impairment, IVIg discontinuation should be considered.
Danish: I tilfælde af nedsat nyrefunktion skal seponering af IVIg overvejes.
English: For safety information with respect to transmissible agents, see section 4.4.
Danish: Angående sikkerhedsinformation vedrørende stoffer, der kan overføres, henvises til pkt.4.4.
English: Secondary immunodeficiencies
Danish: Sekundære immundefekter
English: Body temperature increased
Danish: Øget kropstemperatur
English: In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Danish: I de fleste tilfælde er risikofaktorerne blevet identificeret: eksisterende nyreinsufficiens, diabetes mellitus, hypovolæmi, adipositas, samtidig brug af nefrotoksiske lægemidler eller alder over 65 år.
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: Hvis der ikke observeres nogen virkning af behandlingen efter 6 måneder, skal behandlingen seponeres.
English: Blood pressure systolic increased, Body temperature increased, Coombs test positive
Danish: Stigning i systolisk blodtryk, øget kropstemperatur, positiv Coombs test
English: - If you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for humant normalt immunglobulin eller et af de øvrige indholdsstoffer i Flebogamma DIF (angivet i punkt 6).
English: • asthma
Danish: • astma
English: Replacement therapy: Primary immunodeficiency syndromes
Danish: Substitutionsterapi: Primære immundefektsyndromer
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Danish: Humant normalt immunglobulin indeholder de IgG-antistoffer, der forekommer hos normalbefolkningen.
English: In case of rubella, mumps and varicella a period of up to 3 months should elapse after receiving this medicine and before receiving these vaccines.
Danish: I tilfælde af røde hunde, fåresyge og skoldkopper skal der gå en periode på op til 3 måneder efter denne medicin gives og før disse vacciner administreres.
English: Anaphylaxis can develop in patients - with undetectable IgA who have anti-IgA antibodies - who had tolerated previous treatment with human normal immunoglobulin
Danish: Der kan udvikles anafylaksi hos patienter - med ikke-detekterbart IgA, som har anti-IgA-antistoffer - som tolererede tidligere behandling med humant normalt immunglobulin
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 man fremstiller lægemidler ud fra blod eller plasma fra mennesker, tager man flere forholdsregler for at forhindre overførsel af smitte til patienter.
English: Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Danish: Flerdosis-toksicitetsforsøg samt studier vedrørende embryoføtal toksicitet kan ikke udføres grundet tilførsel af og interferens med antistoffer.
English: If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.
Danish: Hvis der ikke er nogen bivirkninger, kan infusionshastigheden for efterfølgende infusioner langsomt øges til den maksimale hastighed.
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Danish: Andelen af de enkelte IgG-underklasser er ca. 66,6 % IgG1, 28,5 % IgG2, 2,7 % IgG3 og 2,2 % IgG4.
English: Solutions that are cloudy or have deposits should not be used.
Danish: Opløsninger, der er uklare eller indeholder bundfald, må ikke anvendes.
English: Therefore, patients should be examined for the symptoms of Hereditary Fructose Intolerance prior to receiving Flebogamma DIF.
Danish: Derfor skal patienterne undersøges for symptomer på hereditær fructoseintolerans, før de får Flebogamma DIF.
English: Talk to your doctor, pharmacist or nurse before using Flebogamma DIF.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Flebogamma DIF.
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Danish: Fertilitet Klinisk erfaring med immunglobuliner antyder, at der ikke forventes skadelige virkninger på fertilitet.
English: If you have a blood test after receiving Flebogamma DIF, please tell the analyst or your doctor that you have been given this medicine.
Danish: Hvis du får taget blodprøver, efter at du har modtaget Flebogamma DIF, skal du fortælle bioanalytikeren eller lægen, at du har fået dette lægemiddel.
English: After receiving Flebogamma DIF, the results of certain blood tests (serological tests) may be interfered for a certain time.
Danish: Når du har fået Flebogamma DIF, kan resultaterne af visse blodanalyser (serologiske test) blive forstyrret i et stykke tid.
English: In all patients, IVIg administration requires: - adequate hydration prior to the initiation of the infusion of IVIg - monitoring of urine output - monitoring of serum creatinine levels - avoidance of concomitant use of loop diuretics (see 4.5)
Danish: Hos alle patienter kræver administration af IVIg: - tilstrækkelig hydrering før IVIg-infusion - monitorering af diuresen - monitorering af serumkreatinin - undladelse af samtidig brug af slyngediuretika (se pkt.
English: • the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: • inklusion af trin ved behandling af blodet eller plasmaet, der kan inaktivere eller fjerne vira.
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 har udviklet antistoffer mod IgA, da administration af et præparat indeholdende IgA kan føre til anafylaksi.
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 27.9% IgG2, 3.0% IgG3 and 2.5% IgG4.
Danish: Andelen af de enkelte IgG-underklasser er ca. 66,6 % IgG1, 27,9 % IgG2, 3,0 % IgG3 og 2,5 % IgG4.
English: Treatment of adults, children and adolescents (2 - 18 years) who do not have sufficient antibodies (Flebogamma DIF is used as replacement therapy).
Danish: Behandling af voksne, børn og unge (2-18 år), der ikke har tilstrækkeligt med antistoffer (Flebogamme DIF anvendes som substitutionsterapi).
English: 2 g/kg in one dose in association with acetylsalicylic acid
Danish: Kawasakis syndrom2 g/kg legemsvægt i én dosis sammen med acetylsalicylsyre
English: ● feeling cold
Danish: ● kuldefølelse
English: Do not use Flebogamma DIF if you notice that the solution is cloudy or has deposits.
Danish: Brug ikke Flebogamma DIF, hvis du bemærker, at opløsningen er uklar eller indeholder bundfald.
English: Fructose intolerance (see section 4.4).
Danish: Fructoseintolerans (se pkt.
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: Overdosis kan medføre væske-overload og hyperviskositet, især hos patienter i risikogruppen, herunder ældre patienter eller patienter med nedsat hjerte- eller nyrefunktion (se pkt.
English: In babies and young children (aged 0 - 2 years) hereditary fructose intolerance (HFI) may not yet be diagnosed and may be fatal, thus, they must not receive this medicinal product.
Danish: Hos spædbørn og småbørn (i alderen 0-2 år) er hereditær fructoseintolerans (HFI) ikke nødvendigvis diagnosticeret endnu og kan være letal, hvorfor de ikke må få dette lægemiddel.
English: Therefore a detailed history with regard to HFI symptoms has to be taken of each patient prior to receiving Flebogamma DIF.
Danish: Derfor skal der optages en detaljeret sygehistorie med hensyn til HFI-symptomer for hver patient, før de får Flebogamma DIF.
English: Secondary immunodeficiencies (as defined in 4.1)
Danish: Sekundære immundefekter (som defineret i pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Humant normalt immunglobulin (IVIg) 1 ml indeholder:
English: ● bronchitis
Danish: ● bronkitis
English: Alanine aminotransferase increased, Blood pressure increased
Danish: Forhøjet alaninaminotransferase, stigning i blodtryk
English: • Cases of temporary non-infective meningitis (which signs are headache, fear or intolerance of light, stiff neck).
Danish: • Forbigående ikke-infektiøs meningitis (hvor tegn er hovedpine, angst eller lysfølsomhed, nakkestivhed).
English: This medicine contains less than 29,41 mg sodium (main component of cooking/table salt) in each vial of 400 ml.
Danish: Dette lægemiddel indeholder mindre end 29,41 mg natrium (hovedkomponent af madlavnings-/bordsalt) i hvert hætteglas med 400 ml.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Danish: • omhyggelig udvælgelse af blod- og plasmadonorer for at sikre udelukkelse af smittebærere.
English: Replacement therapy in primary immunodeficiency syndromes The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 6 g/l or within the normal reference range for the population age.
Danish: Substitutionsterapi ved primære immundefektsyndromer Dosisregimet skal give en dalkoncentration af IgG umiddelbart forud for næste dosering på mindst 6 g/l eller inden for det normale referenceinterval for populationens alder.
English: It has been reported that the frequency of adverse reactions to IVIg increases with the infusion rate.
Danish: Det er blevet rapporteret, at hyppigheden af bivirkninger over for IVIg stiger i takt med infusionshastigheden.
English: Instituto Grifols, S.A. Polígono Levante Can Guasc, 2
Danish: Polígono Levante Can Guasc, 2
English: Live attenuated virus vaccines
Danish: Vacciner med levende svækket virus
English: This medicinal product contains less than 29,41 mg sodium per vial of 400 ml, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder mindre end 29,41 mg natrium pr. hætteglas med 400 ml, svarende til 1,5 % af den WHO-anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
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, skal langvarig behandling iværksættes efter lægens skøn baseret på patientens respons og responset på vedligeholdelsesbehandlingen.
English: It is expected that the same interactions than those mentioned for the adults may be presented by the paediatric population.
Danish: Interaktionerne nævnt for voksne forventes også at kunne forekomme hos børn.
English: LIST OF EXCIPIENTS D-sorbitol, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER D-sorbitol, vand til injektioner.
English: Paediatric population It is recommended to monitor vital signs when administering Flebogamma DIF to paediatric patients.
Danish: Monitorering af vitale parametre anbefales, når Flebogamma DIF administreres til pædiatriske patienter.
English: In babies and young children (aged 0 - 2 years) hereditary fructose intolerance may not yet be diagnosed and may be fatal, thus, they must not receive this medicine (see special warnings about excipients at the end of this section).
Danish: Hos spædbørn og småbørn (i alderen 0-2 år) er hereditær fructoseintolerans ikke nødvendigvis diagnosticeret endnu og kan være letal, hvorfor de ikke få må få dette lægemiddel (se særlige advarsler om indholdsstoffer i slutningen af dette punkt).
English: TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension.
Danish: TRALI er karakteriseret ved svær hypoksi, dyspnø, takypnø, cyanose, feber og hypertension.
English: Increase in the frequency of adverse reactions through the clinical trials likely related to the increased infusion rate has been observed (see section 4.2).
Danish: Der er observeret stigning i hyppigheden af bivirkninger gennem de kliniske forsøg, som sandsynligvis var relateret til den øgede infusionshastighed (se pkt.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Danish: Fordelingen af immunglobulin G-underklasser er omtrent proportional med fordelingen i naturligt humant plasma.
English: E-08150 Parets del Vallès Barcelona, Spain
Danish: E-08150 Parets del Vallès Barcelona, Spanien
English: This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your heart or your kidneys.
Danish: Dette kan især ske, hvis du er risikopatient, fx ældre eller har problemer med hjertet eller nyrerne.
English: Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4):
Danish: Bivirkninger forårsaget af humant normalt immunglobulin (efter faldende hyppighed) omfatter (se også pkt.
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2 - 5 days
Danish: 0,4 g/kg/dag på dag 1, gentages eventuelt én gang inden for 3 dage i 2 - 5 dage
English: • Cases of transient cutaneous reactions (side effects on your skin).
Danish: • Forbigående hudreaktioner (bivirkninger på huden).
English: • Kawasaki disease (in this case in conjunction with acetylsalicylic acid therapy), an illness in children where the blood vessels (arteries) in the body become enlarged.
Danish: • Kawasakis syndrom (i dette tilfælde sammen med behandling med acetylsalicylsyre), en sygdom hos børn, hvor blodkarrene (arterierne) i kroppen bliver forstørrede.
English: • Multifocal motor neuropathy (MMN), a rare disease causing slow progressive asymmetric limb weakness without sensory loss.
Danish: • Multifokal motorisk neuropati (MMN), en sjælden sygdom, der forårsager en langsom, tiltagende, asymmetrisk svaghed uden sensorisk tab.
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Danish: Immunglobuliner er ikke blevet kædet sammen med hepatitis A- eller parvovirus B19-infektioner, sandsynligvis fordi antistofferne mod dem i produktet virker beskyttende.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Danish: Kliniske erfaringer med immunglobuliner viser, at der ikke forventes skadelige virkninger på svangerskabet eller på fosteret og den nyfødte.
English: Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Spain
Danish: Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Spanien