FrancophonIA/ELRC3.0 huggingface dataset:
English: • You are overweight, are elderly, have diabetes, have been bedridden for a long time, have high blood pressure, have low blood volume (hypovolaemia), have problems with your blood vessels (vascular diseases), have an increased tendency for blood clotting (thrombophilia or thrombotic episodes) or have a disease or a condition which causes your blood to thicken (hyperviscous blood).
Danish: • Du er overvægtig, ældre, har diabetes, har været sengeliggende i lang tid, har højt blodtryk, har nedsat blodvolumen (hypovolæmi), har problemer med dine blodkar (karsygdomme), har en øget tendens til at danne blodpropper (trombofili eller trombotiske episoder) eller har en lidelse der gør, at dit blod fortykkes (hyperviskøst blod).
English: The treatment can be repeated if relapse occurs.
Danish: I tilfælde af tilbagefald kan behandlingen gentages.
English: There are 5 groups: 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: Der er 4 grupper: Patienter, som ikke har et tilstrækkeligt stort antal blodplader (primær immuntrombocytopeni (ITP)), og er i højrisikogruppe for blødning eller skal have foretaget en operation i den nærmeste fremtid.
English: • Because the solution contains no preservative, your healthcare professional must infuse it immediately after opening the vial.
Danish: • Da injektionsvæskeen ikke indeholder konserveringsmidler, skal sundhedspersonalet infundere den, så hurtigt som muligt efter åbning af flasken.
English: Rarely human normal immunoglobulins including Privigen 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 humant normalt immunglobulin, herunder Privigen, udløse et pludseligt blodtryksfald samt i enkeltstående tilfælde anafylaktisk chok, selv når patienten ikke har udvist overfølsomhed ved tidligere administration.
English: In the first CIDP study, a prospective multicenter open label trial (Privigen impact on mobility and autonomy PRIMA study), 28 patients (13 subjects who have previously received IVIG and 15 subjects not) were treated with a Privigen loading dose of 2g/kg bw given over 2-5 days followed by 6 maintenance doses of 1g/kg bw over 1-2 days every three weeks.
Danish: I det første CIDP-studie, et prospektivt open-label-multicenterforsøg (Privigens indvirkning på PRIMA-mobilitets- og autonomiundersøgelse), blev 28 patienter (13 forsøgspersoner, som tidligere havde fået IVIG og 15 forsøgspersoner, som ikke havde) behandlet med en Privigen-begyndelsesdosis på 2 g/kg legemsvægt givet over 2-5 dage efterfulgt af 6 vedligeholdelsesdoser på 1 g/kg legemsvægt over 1-2 dage hver 3. uge.
English: Patients with Kawasaki disease.
Danish: Patienter med Kawasakis sygdom.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE
English: Haemolysis has rarely been reported in patients given replacement therapy for PID.
Danish: Der er kun sjældent blevet rapporteret om hæmolyse hos patienter, der har fået substitutionsbehandling for PID.
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 det nyfødte barn mod patogener, der har adgang via slimhinder.
English: It is strongly recommended that every time Privigen 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 præparatets navn og batchnummer, hver gang Privigen administreres til en patient for at registrere forbindelsen mellem patienten og den pågældende batch.
English: • chest pain, chest discomfort, painful respiration due to transfusion related lung injury (TRALI) Tell your doctor or healthcare professional immediately if you have any of the above symptoms.
Danish: • brystsmerter, gener i brystet, smerter, når du trækker vejret, på grund af transfusionsrelateret lungesygdom (TRALI) fortæl det omgående til lægen eller sundhedspersonalet, hvis du har nogen af ovenstående symptomer.
English: For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Danish: 4.4 vedrørende sikkerhed i forbindelse med transmissible agenser, samt yderligere oplysninger om risikofaktorer.
English: Extension Study (N=13) ZLB05_006CR Median (Range)
Danish: Forlængelses studie (N=13) ZLB05 006CR Median (område)
English: Tell your doctor or healthcare professional if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nyligt.
English: Symptoms typically appear within 1 to 6 hours following treatment.
Danish: Symptomer fremkommer typisk inden for 1-6 timer efter behandlingen.
English: Solution for infusion (10%) Contains 1 vial.
Danish: Infusionsvæske, opløsning (10 %) Indeholder 1 hætteglas.
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with Privigen.
Danish: Evnen til at føre motorkøretøj eller betjene maskiner kan være forringet pga. visse bivirkninger af Privigen.
English: Human normal immunoglobulin 100 mg IgG purity ................................. ≥ 98% IgA ............................ ≤ 25 micrograms
Danish: Humant normalt immunglobulin100 mg IgG-renhed .............................. ≥ 98 % IgA ............................. ≤ 25 mikrogram2,5 g/25 ml
English: • In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Privigen.
Danish: • I meget sjældne tilfælde kan transfusionsrelateret akut lungesygdom (TRALI) forekomme efter behandling med immunglobuliner, herunder Privigen.
English: The MRC responder rate, an increase of at least 3 points, was 84.8% which was similar in previously treated (81.5% [58.95, 100.00]) and untreated (86.7% [69.46, 100.00]) patients.
Danish: MRC-respondentraten var 84,8 %, en stigning på mindst 3 point, hvilket var enssvarende hos tidligere behandlede (81,5 % [58,95; 100,00]) og ubehandlede (86,7 % [69,46; 100,00]) patienter.
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Danish: Tilstrækkelige doser af lægemidlet kan normalisere unormalt lave immunglobulin Gniveauer.
English: This is a slowly progressive disease of the motor nerves with weakness of arms and legs.
Danish: Dette er en langsomt udviklende sygdom i de motoriske nerver, der giver svaghed i arme og ben.
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration.
Danish: Hæmolytisk anæmi kan udvikles efter behandling med IVIg pga. forstærket RBC-sekvestrering.
English: IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Danish: IVIg-præparater kan indeholde blodtypeantistoffer, der kan optræde som hæmolysiner og inducere in vivo belægning med immunglobulin på røde blodlegemer (RBC), hvilket kan medføre 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 during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Danish: Det er særlig vigtigt, at patienter, som ikke tidligere har fået humant normalt immunglobulin, som skifter over fra et alternativt IVIg-præparat, eller som har haft et længere interval siden sidste infusion, overvåges under den første infusion og i den første time efter den første infusion for at opdage potentielle tegn på bivirkninger.
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, patients with diseases which increase blood viscosity).
Danish: Man bør udøve forsigtighed ved ordinering og infusion af IVIg til obese patienter og patienter med præ-eksisterende risikofaktorer for tromboemboliske forstyrrelser (såsom høj alder, hypertension, diabetes mellitus og tidligere vaskulære sygdomme eller tromboemboliske episoder, patienter med erhvervede eller arvelige trombofiliske lidelser, patienter med længere perioder med ubevægelighed, patienter med alvorlig hypovolæmi, patienter med sygdomme, der forhøjer blodets viskositet).
English: If dilution prior to infusion is desired, Privigen may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5%).
Danish: Hvis fortynding forud for infusion ønskes, kan Privigen fortyndes med 5 % glucoseopløsning til en slutkoncentration på 50 mg/ml (5 %).
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 viruses such as hepatitis A virus (HAV) and parvovirus B19.
Danish: De trufne forholdsregler anses for at være effektive mod kappebærende vira såsom human immundefektvirus (HIV), hepatitis B virus (HBV) og hepatitis C virus (HCV) og mod ikkekappebærende vira som hepatitis A virus (HAV) og parvovirus B19.
English: Noncardiogenic pulmonary edema may very rarely occur following treatment with IVIg products, including Privigen.
Danish: Ikke-kardiogent lungeødem kan i meget sjældne tilfælde forekomme efter behandling med IVIgprodukter, herunder Privigen.
English: In PID patients who have tolerated the infusion rate of 4.8 ml/kg bw/hr well, the rate may be further increased gradually to a maximum of 7.2 ml/kg bw/hr.
Danish: Hos PID-patienter, som har tolereret infusionshastigheden på 4,8 ml/kg legemsvægt/time godt, kan hastigheden gradvist øges til et maksimum på 7,2 ml/kg legemsvægt/time.
English: By adjusted INCAT score, the responder rate by week 13 was 72.9 % (151 / 207 patients), with 149 patients responding already by week 10.
Danish: Med den justerede INCAT score var respondentraten i uge 13 72,9 % (151 / 207 patienter) med 149 patienter, der responderede allerede i uge 10. I alt 43 af de 207 patienter opnåede en bedre CIDP
English: On day 3 patients could receive a second dose of 1 g/ kg bw, for patients with a platelet count of < 50×109 / l on day 3 this second dose was mandatory.
Danish: På dag 3 kunne patienterne få en anden dosis på 1 g/kg legemsvægt, mens denne anden dosis var obligatorisk for patienter med et trombocyttal på <50×109/l på dag 3.
English: For storage conditions after first opening of the medicinal product and after dilution, see section 6.3.
Danish: Opbevaringsforhold efter anbrud af lægemidlet og efter fortynding, se pkt.
English: A second dose in subjects with platelet counts ≥ 50×109 /l after the first dose provided a relevant additional benefit in terms of higher and longer-lasting increases in platelet counts compared to a single dose.
Danish: En anden dosis til patienter med et trombocyttal på ≥50×109/l efter den første dosis gav en relevant yderligere fordel med højere og længerevarende trombocyttal sammenlignet med en enkelt dosis.
English: Myalgia (including muscle spasms, musculoskeletal stiffness, musculoskeletal pain)
Danish: Myalgi (herunder muskelspasmer, muskuloskeletal stivhed, muskuloskeletale smerter)
English: Patients with Guillain-Barré syndrome.
Danish: Patienter med Guillain-Barrés syndrom.
English: This medicinal product must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler, fortyndingsvæsker eller opløsningsvæsker end dem, der er anført i pkt.
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr); - are carefully monitored for any symptoms throughout the infusion period.
Danish: Mulige komplikationer kan ofte undgås ved at sikre, at patienterne: - ikke er overfølsomme over for humant normalt immunglobulin ved initialt at injicere lægemidlet langsomt (≤0,3 ml/kg legemsvægt/time),
English: When may slowing or stopping the infusion be required?
Danish: Hvornår kan det være påkrævet at sænke infusionshastigheden eller stoppe infusionen?
English: In patients defined as INCAT non-responders, muscle strength improved by 5.5 points (95% confidence interval [0.6, 10.2]) as compared to INCAT responders (7.4 points (95% confidence interval [4.0, 11.7])
Danish: Hos patienter, der blev defineret som INCAT-ikke-respondenter, var muskelstyrken forbedret med 5,5 point (95 % konfidensinterval [0,6; 10,2]) sammenlignet med INCAT-respondenterne (7,4 point (95 % konfidensinterval [4,0; 11,7])
English: The dose required to achieve a trough level of 5 to 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month.
Danish: Den dosis, som kræves for at opnå en mindste-koncentration på 5 til 6 g/l, ligger i størrelsesordenen 0,2 til 0,8 g/kg legemsvægt om måneden.
English: Immunoglobulins are a normal constituent of the human body.
Danish: Immunglobuliner er normale bestanddele i menneskekroppen.
English: 1 ml contains: Human normal immunoglobulin 100 mg. IgG purity ≥ 98%.
Danish: En ml indeholder: Humant normalt immunglobulin 100 mg. IgG-renhed ≥ 98 %.
English: Loss of kidney function with fatal outcome has occurred in isolated haemolysisrelated cases.
Danish: Nyresvigt med dødelig udgang er forekommet i enkeltstående hæmolysetilfælde.
English: Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Danish: Meget sjældent: Transfusionsrelateret akut lungesygdom og tromboemboliske reaktioner såsom hjerteinfarkt, slagtilfælde, lungeemboli og dyb venetrombose.
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactoid reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Danish: I sjældne tilfælde kan humant normalt immunglobulin fremkalde blodtryksfald med anafylaktoid reaktion, selv hos patienter, som tidligere har tålt behandling med humant normalt immunglobulin.
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Danish: Der er forekommet indberetninger af akut nyresvigt hos patienter i behandling med IVIg.
English: Excipients: L-proline, water for injections.
Danish: Hjælpestoffer: L-prolin, vand til injektionsvæsker.
English: No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Danish: Der konstateredes ingen forskel i de farmakodynamiske egenskaber hos voksne og pædiatriske patienter i studierne.
English: The INCAT responder rate was 60.7% (95% confidence interval [42.41, 76.4]).
Danish: INCAT-respondentraten var 60,7 % (95 % konfidensinterval [42,41; 76,4]).
English: Privigen is essentially sodium free.
Danish: Privigen er stort set fri for natrium.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Danish: Indenfor hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor hyppige de er.
English: Muscle strength as measured by the MRC (Medical Research Council) Score improved in all patients by 6.9 points (95% confidence interval [4.11, 9.75], in previously treated patients by 6.1 points (95% confidence interval [2.72, 9.44]) and in untreated patients by 7.7 points (95% confidence interval [2.89, 12.44]).
Danish: MRC- (Medical Research Council) pointskalaen, blev forbedret hos alle patienter med 6,9 point (95 % konfidensinterval) [4,11; 9,75], hos tidligere behandlede patienter med 6,1 point (95 % konfidensinterval [2,72; 9,44]) og hos ubehandlede patienter med 7,7 point (95 % konfidensinterval [2,89, 12,44]).
English: Common (may occur with up to 1 in 10 patients):
Danish: Almindelige: (kan forekomme hos op til 1 ud af 10 patienter):
English: Each vial of 25 ml solution contains: 2.5 g human normal immunoglobulin Each vial of 50 ml solution contains: 5 g human normal immunoglobulin Each vial of 100 ml solution contains: 10 g human normal immunoglobulin Each vial of 200 ml solution contains: 20 g human normal immunoglobulin Each vial of 400 ml solution contains: 40 g human normal immunoglobulin
Danish: Hvert hætteglas med 25 ml infusionsvæske indeholder 2,5 g humant normalt immunglobulin Hvert hætteglas med 50 ml infusionsvæske indeholder 5 g humant normalt immunglobulin Hvert hætteglas med 100 ml infusionsvæske indeholder 10 g humant normalt immunglobulin Hvert hætteglas med 200 ml infusionsvæske indeholder 20 g humant normalt immunglobulin Hvert hætteglas med 400 ml infusionsvæske indeholder 40 g humant normalt immunglobulin
English: TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
Danish: TRALI er kendetegnet ved svær respiratorisk påvirkning, lungeødem, hypoksæmi, normal funktion af venstre ventrikel og feber.
English: Because the solution contains no preservative, Privigen should be infused as soon as possible.
Danish: Da injektionsvæskeen ikke indeholder konserveringsmidler, skal Privigen infunderes så snart som muligt.
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)* The recommended starting dose is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw over 1 to 2 consecutive days every 3 weeks.
Danish: Kronisk inflammatorisk demyeliniserende polyneuropati (CIDP)* Den anbefalede startdosis er 2 g/kg legemsvægt fordelt over 2 til 5 på hinanden følgende dage efterfulgt af vedligeholdelsesdosis på 1 g/kg legemsvægt over 1 til 2 på hinanden følgende dage hver 3. uge.
English: This is a chronic disease that is characterised by inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and upper limbs.
Danish: Det er en kronisk sygdom, der er karakteriseret ved inflammation i de perifere nerver, der forårsager muskelsvaghed og/eller følelsesløshed hovedsageligt i benene og armene.
English: If dilution is desired, 5% glucose solution should be used.
Danish: Hvis fortynding ønskes, bør 5 % glucoseopløsning anvendes.
English: Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Danish: Privigen 100 mg/ml infusionsvæske, opløsning Humant normalt immunglobulin (IVIg)
English: Dyspnoea (including chest pain, chest discomfort, painful respiration)
Danish: Dyspnø (herunder brystsmerter, ubehag i brystet, smertefuld respiration)
English: Routine laboratory tests may commonly reveal changes to liver functions (hyperbilirubinaemia) as well as changes in blood count (e.g. Coombs' (direct) test positive), increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase).
Danish: Rutinemæssige laboratorieprøver kan afsløre ændringer af leverfunktioner (hyperbilirubinæmi samt ændringer i blodtallet (f.eks. Coombs' (direkte) test positiv), forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet blodlaktatdehydrogenase).
English: Starting dose: 2 g/kg given over 2-5 consecutive days.
Danish: Startdosis: 2 g/kg administreret over 2-5 på hinanden følgende dage.
English: • if you are allergic to human immunoglobulins or to proline.
Danish: • hvis du er overfølsom over for antistoffer fra mennesker (humane immunglobuliner) eller over for prolin.
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella.
Danish: Behandling med immunglobulin kan i en periode på mindst seks uger og op til tre måneder svække effekten af levende svækkede virusvacciner mod f.eks. mæslinger, røde hunde, fåresyge og skoldkopper.
English: Uncommon (may occur with up to 1 in 100 patients):
Danish: Ikke almindelige: (kan forekomme hos op til 1 ud af 100 patienter):
English: Primary immune thrombocytopenia (ITP)
Danish: Immunmodulation Primær immun trombocytopeni (ITP)
English: Human normal immunoglobulin (IVIg)*
Danish: Humant normalt immunglobulin (IVIg)*
English: Symptoms typically appear within 1 to 6 hours after receiving treatment.
Danish: Symptomer fremkommer typisk inden for 1-6 timer, efter at du har fået behandlingen.
English: This is an acute disease that is characterised by inflammation of the peripheral nerves that causes severe muscle weakness mainly in the legs and upper limbs.
Danish: Det er en akut sygdom, der karakteriseres ved betændelse i de perifere nerver, og som forårsager alvorlig muskelsvækkelse hovedsageligt i ben og øvre ekstremiteter.
English: In subjects with platelet counts < 50×109 / l after the first dose, 30% showed a platelet response of ≥ 50×109 / l after the mandatory second dose.
Danish: Hos patienter med et trombocyttal på <50×109/l efter den første dosis havde 30 % en trombocytreaktion på ≥50×109/l efter den obligatoriske anden dosis.
English: Tell your doctor if you are known to have medical problems.
Danish: Fortæl det til lægen, hvis du har nogen helbredsproblemer eller sygdomme
English: They may occur even if you have previously received human immunoglobulins and had tolerated them well.
Danish: De kan forekomme, hvis du tidligere har fået antistoffer fra mennesker (humane immunglobuliner) og har tålt dem godt.
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Danish: Hos patienter med risiko for tromboemboliske bivirkninger bør IVIg-produkter indgives med den lavest mulige infusionshastighed og dosis.
English: Anaphylactic shock
Danish: Anafylaktisk chok
English: If dilution is desired, 5% glucose solution is recommended.
Danish: Hvis der ønskes fortynding, anbefales 5 % glucoseopløsning.
English: The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) given once, followed by at least 0.2 g/kg bw every 3 to 4 weeks.
Danish: Den anbefalede initialdosis er 0,4 til 0,8 g/kg legemsvægt givet én gang efterfulgt af mindst 0,2 g/kg legemsvægt hver 3. til 4. uge.
English: - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
Danish: • Sekundære immundefekter (SID) hos patienter, som lider af svære eller tilbagevendende infektioner, ineffektiv antimikrobiel behandling og enten bevist specifikt antistofsvigt (PSAF)*
English: • It is strongly recommended that every time you are given a dose of Privigen the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt at notere præparatets navn og batchnummer, hver gang du får indgivet en dosis Privigen for at have en registrering af de anvendte batcher.
English: If you get any side effects, talk to your doctor or healthcare professional.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Three to six months are required after the initiation of therapy for equilibration to occur.
Danish: Ligevægt indtræffer 3 til 6 måneder efter indledning af behandlingen.