FrancophonIA/ELRC3.0 huggingface dataset:
English: Any unused solution should be discarded.
Danish: Ubrugte opløsninger bør kasseres.
English: MedDRA System Organ Class
Danish: MedDRA systemorganklasser
English: • hepatomegaly or splenomegaly
Danish: • Hepatomegali eller splenomegali.
English: Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Danish: Cerezyme bør ikke gives som en blanding med andre lægemidler i samme infusion (drop).
English: Rare (may affect up to 1 in 1,000 people): - anaphylactoid reactions
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer): - anafylaktiske reaktioner
English: It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.
Danish: Det anbefales, at Cerezyme anvendes umiddelbart efter, at det er blevet blandet med sterilt vand.
English: If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated.
Danish: Hvis disse reaktioner forekommer, anbefales en umiddelbar afbrydelse af Cerezyme-infusion og at passende medicinsk behandling indledes.
English: Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health.
Danish: Behandlingsnaive kvinder bør tilrådes at påbegynde behandling inden konception for at bevare optimalt helbred.
English: Paediatric population No dose adjustment is necessary for the paediatric population.
Danish: Pædiatrisk population Det er ikke nødvendigt at justere dosis hos pædiatrisk population.
English: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly.
Danish: Som med ethvert intravenøst proteinprodukt er kraftige allergisk-lignende overfølsomhedsreaktioner mulige, men opstår almindeligvis ikke.
English: - if you are allergic to imiglucerase or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for imiglucerase eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table below.
Danish: Bivirkninger er angivet efter systemorganklasse og hyppighed (almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100) og sjælden (≥1/10.000 til <1/1.000)) i tabellen nedenfor.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Danish: Ikke-kliniske data viser ingen speciel fare for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved enkelt og gentagen dosering og genotoksicitet.
English: Intravenous use Read the package leaflet before use.
Danish: Intravenøs anvendelse Læs indlægssedlen før brug.
English: The cause can be unknown, or it can be due to heart, lung or liver problems.
Danish: Grunden kan være ukendt, eller det kan skyldes problemer med hjertet, lungerne eller leveren.
English: It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child's gastrointestinal tract
Danish: Det vides ikke om den aktive substans udskilles i human mælk, men enzymet fordøjes sandsynligvis i barnets gastrointestinale kanal.
English: The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time.
Danish: Den naturlige udvikling af Gauchers sygdom viser normalt progression med risiko for irreversible komplikationer, der efterhånden opstår i forskellige organer.
English: Subsequent infusions may need to occur in a clinical setting.
Danish: Efterfølgende infusion skal muligvis finde sted i kliniske omgivelser.
English: Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
Danish: Dosis kan afrundes til nærmeste hele hætteglas, så længe den månedlige indgiftsdosis grundlæggende forbliver uændret.
English: • anaemia after exclusion of other causes, such as iron deficiency
Danish: • Anæmi efter udelukkelse af andre årsager, f.eks. jernmangel.
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter “EXP”.
English: A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
Danish: En række doseringsregimer har vist sig effektiv over for nogle af eller alle sygdommens ikkeneurologiske manifestationer.
English: Instructions for use - reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Danish: Instruktioner for anvendelse - rekonstituering, fortynding og administration Hvert hætteglas Cerezyme er kun til engangsbrug.
English: Dose and infusion rate should remain constant while at home, and not be changed without supervision of a health care professional.
Danish: Dosis og infusionshastighed bør være konstant, når infusion finder sted hjemme, og må ikke ændres uden supervision af sundhedspersonale.
English: Talk to your doctor or pharmacist before using Cerezyme: - if you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Cerezyme: - hvis du bliver behandlet med Cerezyme, kan du opleve en reaktion, mens du får indgivet medicinen eller kort tid herefter.
English: Once individual patient response for all relevant clinical manifestations is wellestablished, dosages and frequency of administration may be adjusted with the goal to either maintain already reached optimal parameters for all clinical manifestations or further improve those clinical parameters which have not yet been normalised.
Danish: Når den individuelle patientrespons for alle relevante kliniske manifestationer er veletableret, kan dosering og indgivelseshyppighed justeres med det formål enten at opretholde allerede opnåede optimale parametre for alle kliniske manifestationer eller yderligere forbedre de kliniske parametre, som endnu ikke er normaliserede.
English: You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.
Danish: Du kan bede din læge om at registrere dine patientoplysninger i “ICGG Gaucher Registry”.
English: Cerezyme has no or negligible influence on the ability to drive and use machines.
Danish: Cerezyme påvirker ikke eller kun i ubetydelig grad evnen til at føre bil eller betjene maskiner.
English: Occasionally, small dosage adjustments may be made to avoid discarding partially used vials.
Danish: Der kan lejlighedsvis foretages små dosisjusteringer for ikke at kassere delvist brugte hætteglas.
English: Gaucher disease is associated with increased morbidity and early mortality.
Danish: Gauchers sygdom er forbundet med øget morbiditet og tidlig mortalitet.
English: Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Danish: Patienterne bør tilrådes at ophøre med infusion af produktet og kontakte egen læge ved nævnte symptomer.
English: Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Danish: Efter infusionen faldt plasmaenzymaktiviteten hurtigt med en halveringstid på 3,6-10,4 minutter.
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).
Danish: Du kan have behov for at få givet yderligere medicin for at forhindre en allergisk reaktion (f.eks. antihistaminer eller paracetamol).
English: The clinical manifestations of Gaucher disease can adversely affect quality of life.
Danish: De kliniske manifestationer af Gauchers sygdom kan påvirke livskvaliteten negativt.
English: Generally, improvements in organ systems with a faster turnover rate, such as the haematological, can be noted far more rapidly than in those with a slower turnover, such as the bone.
Danish: Generelt kan der langt hurtigere observeres forbedringer i organsystemer med en hurtigere omsætningshastighed (for eksempel de hæmatologiske systemer) end i organsystemer med en langsommere omsætning (for eksempel knogler).
English: Symptoms suggestive of hypersensitivity (* marked in the table above) have been noted, overall in approximately 3% of the patients.
Danish: Symptomer, der tyder på overfølsomhed (markeret med * i tabellen ovenfor), er set hos ialt ca. 3 % af patienterne.
English: Educational materials for the use of Cerezyme in home infusion, consisting of:
Danish: Uddannelsesmateriale for anvendelse af Cerezyme ved hjemme-infusion bestående af:
English: No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development.
Danish: Der er ikke udført dyreforsøg for at vurdere effekten af Cerezyme på drægtigheden, den embryonale/føtale udvikling, parturition eller den postnatale udvikling.
English: • bone disease after exclusion of other causes such as Vitamin D deficiency
Danish: • Knoglesygdomme efter udelukkelse af andre årsager, f.eks. D-vitaminmangel.
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Danish: Det anbefales at indgive den fortyndede opløsning gennem et inline, lavt proteinbindende, 0,2 µm filter for at fjerne eventuelle proteinpartikler.
English: Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).
Danish: Instruktioner for korrekt anvendelse Cerezyme gives gennem et drop ind i en vene (ved intravenøs infusion).
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
Danish: • Vejledning til sundhedspersonale, der behandler patienter med Gauchers sygdom.
English: • Manual for patients with Gaucher disease who receive home infusion;
Danish: • Vejledning til patienter med Gauchers sygdom, som får infusionen hjemme;
English: Genzyme Europe B.V. - NL Store in a refrigerator.
Danish: Genzyme Europe B.V.- NL Opbevares i køleskab.
English: Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Danish: Patienter med Gauchers sygdom, som bliver gravide, kan få en periode med øget sygdomsaktivitet under graviditet og puerperium.
English: This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
Danish: Dette indbefatter øget risiko for skeletal manifestation, eksacerbation af cytopeni, hæmoragi og øget behov for transfusion.
English: - The active substance is imiglucerase.
Danish: - Aktivt stof: imiglucerase.
English: The patient or caregiver will be instructed in infusion technique and the keeping of a treatment diary.
Danish: Patienten eller plejeren skal instrueres i infusionsteknik og i, hvordan der føres behandlingsdagbog.
English: Cerezyme 400 U
Danish: Cerezyme 400 E
English: The rate and extent of response to Cerezyme treatment is dose-dependent.
Danish: Hastigheden og udstrækningen af respons på behandling med Cerezyme er dosisafhængig.
English: Foetal demise has been reported rarely, although it is not clear whether this related to the use of Cerezyme or to the underlying Gaucher disease.
Danish: Fosterdød er rapporteret i sjældne tilfælde, selvom det ikke er klarlagt, om det var relateret til brug af Cerezyme eller til den underliggende Gauchers sygdom.
English: Cerezyme therapy reduces the requirement for splenectomy in most cases and early treatment with Cerezyme has been associated with a reduced risk of pulmonary hypertension.
Danish: Behandling med Cerezyme nedsætter behovet for splenektomi i de fleste tilfælde, og tidlig behandling med Cerezyme har været associeret med nedsat risiko for pulmonal hypertension.
English: This should lead to an improvement in the safe and effective use of Cerezyme.
Danish: Dette skulle lede til en forbedring af sikkerheden og effektiv anvendelse af Cerezyme.
English: Glucosylceramide is a natural substance in the body, made of sugar and fat.
Danish: Glukosylceramid er en naturlig substans i kroppen, fremstillet af sukker og fedt.
English: Cerezyme has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease.
Danish: Det er vist, at Cerezyme forbedrer både de mentale og fysiske aspekter af livskvaliteten i forbindelse med Gauchers sygdom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET / HÆTTEGLAS
English: The reconstituted volume is 10.6 ml.
Danish: Det rekonstituerede volumen er 10,6 ml.
English: There are no cases of overdose of Cerezyme reported.
Danish: Der er ikke rapporteret tilfælde af overdosering med Cerezyme.
English: Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Danish: Hidtidige oplysninger, der stammer fra anvendelse af en ELISA screening efterfulgt af en bekræftende radioimmunpræcipitationsanalyse, peger på, at der i løbet af det første år af behandlingen dannes IgG antistoffer mod imiglucerase hos ca. 15 % af de behandlede patienter.
English: Signs and symptoms presenting in childhood typically represent more severe Gaucher disease.
Danish: Tegn og symptomer i barndommen repræsenterer typisk mere alvorlig Gauchers sygdom.
English: If you experience a reaction like this, you should tell your doctor immediately.
Danish: Hvis du oplever en sådan reaktion, bør du underrette din læge med det samme.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, England Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland
English: Cerezyme reduces resting energy expenditure rate.
Danish: Cerezyme nedsætter energiforbruget i hvile.
English: The reconstituted volume is 5.3 ml.
Danish: Det rekonstituerede volumen er 5,3 ml.
English: Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy.
Danish: Den begrænsede erfaring består af resultater fra 150 graviditeter (primært baseret på spontan rapportering og gennemgang af litteraturen), og tyder på, at Cerezyme er virkningsfuldt til behandling af underliggende Gauchers sygdom under graviditeten.
English: Name and address of the manufacturer of the biological active substance Genzyme Corporation, 500 Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Name and address of the manufacturers responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof Genzyme Corporation, 500 Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Navn og dresse på de fremstillere, der er ansvarlige for batchfrigivelse Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Storbritannien Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: After reconstitution it is a clear, colourless liquid, free from foreign matter.
Danish: Efter rekonstituering er det en klar, farveløs væske, fri for fremmedlegemer.
English: After reconstitution and dilution, the preparation is administered by intravenous infusion.
Danish: Efter rekonstitution og fortynding gives præparatet ved intravenøs infusion.
English: At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.
Danish: Ved de efterfølgende doser kan infusionshastigheden forhøjes, men bør ikke overstige 1 enhed pr. kg. legemsvægt pr. minut.
English: If not used immediately, in-use storage and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C under protection from light.
Danish: Hvis det ikke anvendes med det samme, er opbevaringsforholdene før og under anvendelsen brugerens ansvar og produktet bør ikke opbevares i mere end 24 timer ved 2°C - 8°C.
English: The recommended dose is 60 units/kg body weight given once every 2 weeks.
Danish: Den anbefalede dosis er 60 E/kg legemsvægt givet én gang hver anden uge.
English: It is not known whether Cerezyme passes via the placenta to the developing foetus.
Danish: Det vides ikke, om Cerezyme overføres via placenta til det udviklende føtus.
English: Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all clinical manifestations of the disease.
Danish: På grund af den heterogene, multisystemiske karakter af Gaucher's sygdom skal doseringen justeres individuelt for hver patient på baggrund af en komplet vurdering af alle kliniske symptomer.
English: Patients treated with 60 U/kg body weight every 2 weeks showed a faster improvement and a greater maximum treatment effect as compared to patients receiving the lower doses.
Danish: Patienter, der blev behandlet med 60 E/kg legemsvægt hver 2. uge udviste hurtigere forbedring og øget maksimal behandlingseffekt sammenlignet med de patienter, som fik lavere doser.
English: The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
Danish: Formålet med dette register er at øge forståelsen af Gauchers sygdom og kontrollere, hvor godt enzym substitutionsbehandling, som Cerezyme, fungerer.
English: Tachycardia*, cyanosis*
Danish: Takykardi*, cyanose*
English: Cerezyme 200 U
Danish: Cerezyme 200 E
English: Gaucher disease is associated with increased glucose production and increased resting energy expenditure rate, which may contribute to fatigue and cachexia.
Danish: Gauchers sygdom er forbundet med forhøjet glucoseproduktion og forhøjet energiforbrug i hvile, hvilket kan bidrage til træthed og kakeksi.
English: In women receiving Cerezyme treatment continuation throughout pregnancy should be considered.
Danish: For kvinder, der får Cerezyme, skal det overvejes at fortsætte behandlingen gennem hele graviditeten.
English: Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted βglucocerebrosidase), ATC code: A16AB02.
Danish: Farmakoterapeutisk klassifikation: enzymer-imiglucerase (rekombinant makrofagrettet βglucocerebrosidase), ATC-kode: A16AB02.
English: In addition, Gaucher disease has been associated with an increased risk of immunoglobulin abnormalities such as hyperimmunoglobulinemia, polyclonal gammopathy, monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma.
Danish: Desuden er Gauchers sygdom blevet forbundet med forhøjet risiko for immunglobulinanomalier såsom hyperimmunglobulinæmi, polyklonal gammopati, monoklonal gammopati af ubestemt signifikans (MGUS) og multipelt myelom.
English: Cerezyme contains sodium
Danish: Cerezyme indeholder natrium
English: This enzyme helps the body control levels of glucosylceramide.
Danish: Dette enzym hjælper kroppen med at kontrollere niveauer af glukosylceramid.
English: It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Danish: Det foreslås, at patienter, der formodes at have reduceret reaktion på behandlingen, overvåges regelmæssigt for dannelse af IgG antistoffer over for imiglucerase.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe vises bivirkninger med faldende alvorlighed.
English: Cerezyme is a white to off-white powder.
Danish: Cerezyme er et hvidt til off-white pulver.
English: There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
Danish: Der er ingen oplysninger om virkningen af Cerezyme på hjernebaserede symptomer hos patienter med kronisk neuronopatisk Gauchers sygdom.
English: Patients diagnosed with pulmonary hypertension, in particular, should receive adequate doses of Cerezyme to ensure control of underlying Gaucher disease as well as be evaluated for the need of additional pulmonary hypertension specific treatments.
Danish: Især patienter med diagnosen pulmonal hypertension bør have tilstrækkelige doser af Cerezyme for at sikre kontrol af den tilgrundliggende Gauchers sygdom og bør desuden vurderes for så vidt angår behovet for yderligere specifik behandling af pulmonal hypertension.
English: In children, Gaucher disease can lead to growth retardation and delayed puberty.
Danish: Hos børn kan Gauchers sygdom føre til vækstretardering og forsinket pubertet.
English: Flushing*, hypotension*
Danish: Rødmen*, hypotension*
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysningerom dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Plasma clearance ranged from 9.8 to 20.3 ml/min/kg, (mean ± S.D, 14.5 ± 4.0 ml/min/kg).
Danish: Plasma clearance var fra 9,8 til 20,3 ml/min./kg (gennemsnit ± S.D., 14,5 ±4,0 ml/min./kg).
English: • thrombocytopenia
Danish: • Trombocytopeni.
English: The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Danish: Den normale infusionshyppighed er én gang hver 2. uge; de fleste data er baseret på denne infusionshyppighed.
English: The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Danish: Effekten af Cerezyme på neurologiske symptomer på kronisk neuronopatisk Gaucher patienter er ikke blevet bevist, og der kan ikke anbefales noget specielt doseringsregimen for disse manifestationer (se pkt.
English: Routine evaluation to detect the presence of pulmonary hypertension after diagnosis of Gaucher disease and over time is recommended.
Danish: Rutinemæssige undersøgelser til påvisning af pulmonal hypertension efter diagnosticering af Gauchers sygdom og fortløbende anbefales.
English: The usual frequency of infusion is once every 2 weeks (see section 4.2).
Danish: Den normale infusionshyppighed er én gang hver 2. uge (se pkt.
English: If you have missed an infusion, please contact your doctor.
Danish: Hvis du har hoppet en infusion over, så kontakt din læge.
English: Pulmonary hypertension is a known complication of Gaucher disease.
Danish: Pulmonal hypertension er en kendt komplication ved Gauchers sygdom.
English: Patients with Gaucher disease may also have a low grade inflammatory profile.
Danish: Patienter med Gauchers sygdom kan også have en inflammatorisk profil i lav grad.