natgillin/translations-raw huggingface dataset:
Det aktive stof i Flolan, epoprostenol, er et naturligt prostaglandin, der virker ved at forhindre blodets størkning: Det standser aktiveringen af blodets størkningsmekanisme ved at forhindre blodpladerne i at klumpe sammen (blodpladerne er de elementer i blodet, der muliggør blodets størkning).
The active substance in Flolan, epoprostenol, is a natural occurring prostaglandin that works by stopping the blood from clotting.
Dette kan være hver 6. til 12. måned.
This might be every 6 to 12 months.
Dato for første markedsføringstilladelse: 17. november 1997 Dato for seneste fornyelse: 17. september 2007
Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007
Din dosis vil være specifik for dig.
Your dose will be specific to you.
Af hensyn til den mikrobiologiske sikkerhed skal produktet anvendes med det samme.
From a microbiological safety point of view, the product should be used immediately.
Der er ikke udført nogen interaktionsundersøgelser.
No interaction studies have been performed.
Derfor kan der ikke anbefales noget særligt doseringsregimen.
Therefore no special dosage regimen can be recommended.
De nuværende medicinske standarder for nødbehandling bør observeres.
The current medical standards for emergency treatment are to be observed.
Dine patientdata vil blive registreret anonymt - ingen vil vide, at det er oplysninger om dig.
Your patient data will be registered anonymously- nobody will know it is information about you.
Oplysningerne i denne indlægsseddel gælder for alle patientgrupper, inklusive børn, unge, voksne og de ældre.
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Din læge vil udarbejde din dosis baseret på, hvor alvorlige dine symptomer er og andre faktorer.
Your doctor will work out your dose based on how severe your symptoms are, and other factors.
Kontakt lægen, hvis du ønsker at blive behandlet hjemme.
Please contact your doctor if you would like to be treated at home.
Lægen kan anbefale, at du behandles hjemme, forudsat at du opfylder visse kriterier.
Your doctor may advise that you can be treated at home provided you meet certain criteria.
Ikke-neurologiske manifestationer af Gauchers sygdom omfatter én eller flere af følgende tilstande:
The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
Din læge vil føre nøje kontrol med dit respons på din behandling og kan ændre din dosis (op eller ned), indtil han/hun finder den bedste dosis til at behandle dine symptomer.
Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.
ICGG Gaucher-registret
The ICGG Gaucher Registry
Når denne dosis først er fundet, vil din læge stadigvæk holde øje med dit respons for at sikre sig, at du får den rette dosis.
Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose.
Det kan forekomme, hvadenten patienten behandles med Cerezyme eller ej.
It can occur whether the patient is treated with Cerezyme or not.
Sådanne symptomer er opstået under eller kort efter infusion.
Onset of such symptoms has occurred during or shortly after infusions.
Nogle bivirkninger blev set, mens patienter fik givet medicinen eller kort tid herefter.
Some side effects were seen primarily while patients were being given the medicine or shortly after.
Dette vil ikke medføre tab af imigluceraseaktivitet.
This will not lead to any loss of imiglucerase activity.
Disse symptomer responderer generelt på behandling med antihistaminer og/eller kortikosteroider.
These symptoms generally respond to treatment with antihistamines and/or corticosteroids.
Ubrugte opløsninger bør kasseres.
Any unused solution should be discarded.
MedDRA systemorganklasser
MedDRA System Organ Class
• Hepatomegali eller splenomegali.
• hepatomegaly or splenomegaly
Cerezyme bør ikke gives som en blanding med andre lægemidler i samme infusion (drop).
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Sjælden (kan forekomme hos op til 1 ud af 1.000 personer): - anafylaktiske reaktioner
Rare (may affect up to 1 in 1,000 people): - anaphylactoid reactions
Det anbefales, at Cerezyme anvendes umiddelbart efter, at det er blevet blandet med sterilt vand.
It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.
Hvis disse reaktioner forekommer, anbefales en umiddelbar afbrydelse af Cerezyme-infusion og at passende medicinsk behandling indledes.
If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated.
Behandlingsnaive kvinder bør tilrådes at påbegynde behandling inden konception for at bevare optimalt helbred.
Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health.
Pædiatrisk population Det er ikke nødvendigt at justere dosis hos pædiatrisk population.
Paediatric population No dose adjustment is necessary for the paediatric population.
Som med ethvert intravenøst proteinprodukt er kraftige allergisk-lignende overfølsomhedsreaktioner mulige, men opstår almindeligvis ikke.
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly.
- hvis du er allergisk over for imiglucerase eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
- if you are allergic to imiglucerase or any of the other ingredients of this medicine (listed in section 6).
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.
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.
Ikke-kliniske data viser ingen speciel fare for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved enkelt og gentagen dosering og genotoksicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Intravenøs anvendelse Læs indlægssedlen før brug.
Intravenous use Read the package leaflet before use.
Grunden kan være ukendt, eller det kan skyldes problemer med hjertet, lungerne eller leveren.
The cause can be unknown, or it can be due to heart, lung or liver problems.
Det vides ikke om den aktive substans udskilles i human mælk, men enzymet fordøjes sandsynligvis i barnets gastrointestinale kanal.
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
Den naturlige udvikling af Gauchers sygdom viser normalt progression med risiko for irreversible komplikationer, der efterhånden opstår i forskellige organer.
The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time.
Efterfølgende infusion skal muligvis finde sted i kliniske omgivelser.
Subsequent infusions may need to occur in a clinical setting.
Dosis kan afrundes til nærmeste hele hætteglas, så længe den månedlige indgiftsdosis grundlæggende forbliver uændret.
Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
• Anæmi efter udelukkelse af andre årsager, f.eks. jernmangel.
• anaemia after exclusion of other causes, such as iron deficiency
Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter “EXP”.
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
En række doseringsregimer har vist sig effektiv over for nogle af eller alle sygdommens ikkeneurologiske manifestationer.
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
Instruktioner for anvendelse - rekonstituering, fortynding og administration Hvert hætteglas Cerezyme er kun til engangsbrug.
Instructions for use - reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Dosis og infusionshastighed bør være konstant, når infusion finder sted hjemme, og må ikke ændres uden supervision af sundhedspersonale.
Dose and infusion rate should remain constant while at home, and not be changed without supervision of a health care professional.
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.
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.
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.
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.
Du kan bede din læge om at registrere dine patientoplysninger i “ICGG Gaucher Registry”.
You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.
Cerezyme påvirker ikke eller kun i ubetydelig grad evnen til at føre bil eller betjene maskiner.
Cerezyme has no or negligible influence on the ability to drive and use machines.
Der kan lejlighedsvis foretages små dosisjusteringer for ikke at kassere delvist brugte hætteglas.
Occasionally, small dosage adjustments may be made to avoid discarding partially used vials.
Gauchers sygdom er forbundet med øget morbiditet og tidlig mortalitet.
Gaucher disease is associated with increased morbidity and early mortality.
Patienterne bør tilrådes at ophøre med infusion af produktet og kontakte egen læge ved nævnte symptomer.
Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Efter infusionen faldt plasmaenzymaktiviteten hurtigt med en halveringstid på 3,6-10,4 minutter.
Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Du kan have behov for at få givet yderligere medicin for at forhindre en allergisk reaktion (f.eks. antihistaminer eller paracetamol).
You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).
De kliniske manifestationer af Gauchers sygdom kan påvirke livskvaliteten negativt.
The clinical manifestations of Gaucher disease can adversely affect quality of life.
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).
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.
Symptomer, der tyder på overfølsomhed (markeret med * i tabellen ovenfor), er set hos ialt ca. 3 % af patienterne.
Symptoms suggestive of hypersensitivity (* marked in the table above) have been noted, overall in approximately 3% of the patients.
Uddannelsesmateriale for anvendelse af Cerezyme ved hjemme-infusion bestående af:
Educational materials for the use of Cerezyme in home infusion, consisting of:
Der er ikke udført dyreforsøg for at vurdere effekten af Cerezyme på drægtigheden, den embryonale/føtale udvikling, parturition eller den postnatale udvikling.
No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development.
• Knoglesygdomme efter udelukkelse af andre årsager, f.eks. D-vitaminmangel.
• bone disease after exclusion of other causes such as Vitamin D deficiency
Det anbefales at indgive den fortyndede opløsning gennem et inline, lavt proteinbindende, 0,2 µm filter for at fjerne eventuelle proteinpartikler.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Instruktioner for korrekt anvendelse Cerezyme gives gennem et drop ind i en vene (ved intravenøs infusion).
Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).
• Vejledning til sundhedspersonale, der behandler patienter med Gauchers sygdom.
• Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
• Vejledning til patienter med Gauchers sygdom, som får infusionen hjemme;
• Manual for patients with Gaucher disease who receive home infusion;
Genzyme Europe B.V.- NL Opbevares i køleskab.
Genzyme Europe B.V. - NL Store in a refrigerator.
Patienter med Gauchers sygdom, som bliver gravide, kan få en periode med øget sygdomsaktivitet under graviditet og puerperium.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Dette indbefatter øget risiko for skeletal manifestation, eksacerbation af cytopeni, hæmoragi og øget behov for transfusion.
This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
- Aktivt stof: imiglucerase.
- The active substance is imiglucerase.
Patienten eller plejeren skal instrueres i infusionsteknik og i, hvordan der føres behandlingsdagbog.
The patient or caregiver will be instructed in infusion technique and the keeping of a treatment diary.
Cerezyme 400 E
Cerezyme 400 U
Hastigheden og udstrækningen af respons på behandling med Cerezyme er dosisafhængig.
The rate and extent of response to Cerezyme treatment is dose-dependent.
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.
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.
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.
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.
Dette skulle lede til en forbedring af sikkerheden og effektiv anvendelse af Cerezyme.
This should lead to an improvement in the safe and effective use of Cerezyme.
Glukosylceramid er en naturlig substans i kroppen, fremstillet af sukker og fedt.
Glucosylceramide is a natural substance in the body, made of sugar and fat.
Det er vist, at Cerezyme forbedrer både de mentale og fysiske aspekter af livskvaliteten i forbindelse med Gauchers sygdom.
Cerezyme has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET / HÆTTEGLAS
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / VIAL
Det rekonstituerede volumen er 10,6 ml.
The reconstituted volume is 10.6 ml.
Der er ikke rapporteret tilfælde af overdosering med Cerezyme.
There are no cases of overdose of Cerezyme reported.
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.
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.
Tegn og symptomer i barndommen repræsenterer typisk mere alvorlig Gauchers sygdom.
Signs and symptoms presenting in childhood typically represent more severe Gaucher disease.
Hvis du oplever en sådan reaktion, bør du underrette din læge med det samme.
If you experience a reaction like this, you should tell your doctor immediately.
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, England Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Cerezyme nedsætter energiforbruget i hvile.
Cerezyme reduces resting energy expenditure rate.
Det rekonstituerede volumen er 5,3 ml.
The reconstituted volume is 5.3 ml.
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.
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.
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.
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.
Efter rekonstituering er det en klar, farveløs væske, fri for fremmedlegemer.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Efter rekonstitution og fortynding gives præparatet ved intravenøs infusion.
After reconstitution and dilution, the preparation is administered by intravenous infusion.
Ved de efterfølgende doser kan infusionshastigheden forhøjes, men bør ikke overstige 1 enhed pr. kg. legemsvægt pr. minut.
At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.
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.
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.
Den anbefalede dosis er 60 E/kg legemsvægt givet én gang hver anden uge.
The recommended dose is 60 units/kg body weight given once every 2 weeks.
Det vides ikke, om Cerezyme overføres via placenta til det udviklende føtus.
It is not known whether Cerezyme passes via the placenta to the developing foetus.
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.
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.
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.
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.
Formålet med dette register er at øge forståelsen af Gauchers sygdom og kontrollere, hvor godt enzym substitutionsbehandling, som Cerezyme, fungerer.
The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
Takykardi*, cyanose*
Tachycardia*, cyanosis*
Cerezyme 200 E
Cerezyme 200 U
Gauchers sygdom er forbundet med forhøjet glucoseproduktion og forhøjet energiforbrug i hvile, hvilket kan bidrage til træthed og kakeksi.
Gaucher disease is associated with increased glucose production and increased resting energy expenditure rate, which may contribute to fatigue and cachexia.
For kvinder, der får Cerezyme, skal det overvejes at fortsætte behandlingen gennem hele graviditeten.
In women receiving Cerezyme treatment continuation throughout pregnancy should be considered.
Farmakoterapeutisk klassifikation: enzymer-imiglucerase (rekombinant makrofagrettet βglucocerebrosidase), ATC-kode: A16AB02.
Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted βglucocerebrosidase), ATC code: A16AB02.
Desuden er Gauchers sygdom blevet forbundet med forhøjet risiko for immunglobulinanomalier såsom hyperimmunglobulinæmi, polyklonal gammopati, monoklonal gammopati af ubestemt signifikans (MGUS) og multipelt myelom.
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.
Cerezyme indeholder natrium
Cerezyme contains sodium
Dette enzym hjælper kroppen med at kontrollere niveauer af glukosylceramid.
This enzyme helps the body control levels of glucosylceramide.
Det foreslås, at patienter, der formodes at have reduceret reaktion på behandlingen, overvåges regelmæssigt for dannelse af IgG antistoffer over for imiglucerase.
It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Inden for hver hyppighedsgruppe vises bivirkninger med faldende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Cerezyme er et hvidt til off-white pulver.
Cerezyme is a white to off-white powder.
Der er ingen oplysninger om virkningen af Cerezyme på hjernebaserede symptomer hos patienter med kronisk neuronopatisk Gauchers sygdom.
There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
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.
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.
Hos børn kan Gauchers sygdom føre til vækstretardering og forsinket pubertet.
In children, Gaucher disease can lead to growth retardation and delayed puberty.
Rødmen*, hypotension*
Flushing*, hypotension*