FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al, 2007).
Danish: I en analyse fra et ”ICGG Gaucher Registry” af knoglemineraltætheden hos 342 patienter, hvor man anvendte dual-energy X-ray absorptiometri (DXA), blev der på samme måde efter 8 års behandling opnået normal knoglemineraltæthed med en dosis af Cerezyme på 60 E/kg legemsvægt én gang hver 2. uge, men ikke med lavere doser på 15 og 30 E/kg legemsvægt én gang hver 2. uge (Wenstrup et al,
English: - The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Danish: - Øvrige indholdsstoffer: mannitol, natriumcitrat, citronsyremonohydrat og polysorbat 80.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (1 HÆTTEGLAS, 25 HÆTTEGLAS)
English: The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Danish: Efter fortynding i 0,9 % natriumchloridinfusionsvæske bevares produktets kemiske stabilitet i højst 24 timer, forudsat det opbevares ved 2°C og 8°C, beskyttet mod lys.
English: Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25).
Danish: Cerezyme 400 Enheder fremstår som et pulver til koncentrat til infusionsvæske, opløsning (i en pakningsstørrelse med 1, 5 eller 25 hætteglas).
English: EU/1/97/053/001 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 25 vials of powder for concentrate for solution for infusion
Danish: EU/1/97/053/0011 hætteglas med pulver til koncentrat til infusionsvæske, opløsning EU/1/97/053/002 25 hætteglas med pulver til koncentrat til infusionsvæske, opløsning
English: Anaphylactoid reactions
Danish: Overfølsomhedsreaktioner
English: The most frequent disease manifestations are hepatosplenomegaly, thrombocytopenia, anaemia, and skeletal pathology, The skeletal abnormalities are frequently the most debilitating and disabling features of Gaucher disease.
Danish: De hyppigste sygdomsmanifestationer er hepatosplenomegali, trombocytopeni, anæmi og skeletpatologi.
English: Common (may affect up to 1 in 10 people): - breathlessness - coughing - hives/ localised swelling of the skin or lining of the mouth or throat - itching - rash
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): - kortåndethed - hoste - nældefeber/lokaliseret hævelse af huden eller mund- eller halsslimhinden - kløe - udslæt
English: * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
Danish: * En enzymenhed (E) defineres som den enzymmængde, der katalyserer hydrolysen af et mikromol/min.
English: The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C - 8°C) and in the dark.
Danish: Den fortyndede opløsning kan holde sig op til 24 timer, hvis den opbevares køligt (2°C-8°C) og i mørke.
English: This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Danish: Dette lægemiddel indeholder natrium og indgives i 0,9 % natriumchlorid infusionsvæske.
English: Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease.
Danish: Behandlingen bør ske under tilsyn af læger, som er bekendt med behandling af Gaucher's sygdom.
English: Cerezyme 200 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1 or 25).
Danish: Cerezyme 200 Enheder fremstår som et pulver til koncentrat til infusionsvæske, opløsning (i en pakningsstørrelse med 1 eller 25 hætteglas).
English: Infusion of Cerezyme at home may be considered for patients who are tolerating their infusions well for several months.. Decision to have patient move to home infusion should be made after evaluation and recommendation by the treating physician.
Danish: Infusion af Cerezyme hjemme kan overvejes for patienter, der i adskillige måneder har tålt deres infusioner godt.
English: Mix the infusion solution gently.
Danish: Bland infusionsvæsken forsigtigt.
English: After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Danish: Efter rekonstitution indeholder opløsningen 0,62 mmol natrium (200 E/5 ml).
English: In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
Danish: Der kræves en risk/benefit-vurdering af hver gravid Gaucher patient, eller patienter som ønsker at blive gravide.
English: Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8).
Danish: Patienter med antistoffer mod imiglucerase har større risiko for overfølsomhedsreaktioner.
English: EU/1/97/053/003 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 25 vial of powder for concentrate for solution for infusion
Danish: EU/1/97/053/003 1 hætteglas med pulver til koncentrat til infusionsvæske, opløsning EU/1/97/053/004 5 hætteglas med pulver til koncentrat til infusionsvæske, opløsning EU/1/97/053/005 25 hætteglas med pulver til koncentrat til infusionsvæske, opløsning
English: It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Danish: Det ser ud til, at de patienter, der udvikler IgG antistoffer, kan forventes at gøre det inden for de første 6 måneder af behandlingen.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: KLINISKE OPLYSNINGER 4.1.
English: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Danish: Dette lægemiddel indeholder natrium og administreres i 0,9 % natriumchlorid intravenøs opløsning (se pkt.
English: Excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Danish: Hjælpestoffer: mannitol, natriumcitrat, citronsyremonohydrat og polysorbat 80.
English: After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL).
Danish: Efter rekonstitution indeholder opløsningen 1,24 mmol natrium (400 E/10 ml).
English: But, if you suffer with any shortness of breath you should tell your doctor.
Danish: Hvis du lider af kortåndethed, skal du underrette din læge.
English: The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Danish: Lukningen består af en silikonebehandlet butylprop med børnesikker kapsel.
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (200 U/5 ml).
Danish: Efter rekonstitution indeholder opløsningen 40 enheder (cirka 1,0 mg) imiglucerase pr. ml (200 E/5 ml).
English: After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Danish: Efter rekonstituering indeholder hvert hætteglas Cerezyme 200 enheder imiglucerase i 5 ml (40 enheder pr. ml).
English: The reconstituted solution contains 40 units imiglucerase per ml.
Danish: Den rekonstituerede opløsning indeholder 40 enheder imiglucerase pr. ml.
English: Withdraw 5.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Danish: Fra hvert hætteglas udtages 5,0 ml af den rekonstituerede opløsning, og mængderne blandes.
English: Cerezyme 200 Units powder for concentrate for solution for infusion To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 ml.
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning For at opnå en tilstrækkelig mængde til nøjagtig dispensering indeholder hvert hætteglas en overfyldning på 0,3 ml.
English: Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient's needs and therapeutic response.
Danish: individualiseret dosering i henhold til patientens behov og terapeutiske respons.
English: Withdraw 10.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Danish: Fra hvert hætteglas udtages 10,0 ml af den rekonstituerede opløsning, og mængderne blandes.
English: Cerezyme 400 Units powder for concentrate for solution for infusion To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.6 ml.
Danish: Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning For at opnå en tilstrækkelig mængde til nøjagtig dispensering indeholder hvert hætteglas en overfyldning på 0,6 ml.
English: Cerezyme 400 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Danish: Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel indeholder natrium og gives i 0,9 % natriumchlorid infusionsvæske (se pkt.
English: Cerezyme 200 Units powder for concentrate for solution for infusion The reconstituted solution contains 40 units imiglucerase per ml.
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning Den rekonstituerede opløsning indeholder 40 enheder imiglucerase pr. ml.
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
Danish: Efter rekonstitution indeholder opløsningen 40 enheder (cirka 1,0 mg) imiglucerase pr. ml (400 E/10 ml).
English: After reconstitution, the solution contains 40 units of imiglucerase per ml.
Danish: Efter rekonstitution indeholder opløsningen 40 Enheder imiglucerase pr. ml.
English: Cerezyme 200 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel indeholder natrium og gives i 0,9 % natriumchlorid infusionsvæske (se pkt.
English: After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Danish: Efter rekonstituering indeholder hvert hætteglas Cerezyme 400 enheder imiglucerase i 10 ml (40 enheder pr. ml).
English: These measures will help protect the environment.
Danish: Det skal beskyttes mod lys.
English: One vial contains 200 units of imiglucerase.
Danish: Ét hætteglas indeholder 200 Enheder imiglucerase.
English: Cerezyme 200 Units Powder for concentrate for solution for infusion Cerezyme 400 Units Powder for concentrate for solution for infusion
Danish: Cerezyme 200 Enheder Pulver til koncentrat til infusionsvæske, opløsning Cerezyme 400 Enheder Pulver til koncentrat til infusionsvæske, opløsning
English: Do not use vials exhibiting foreign particles or discoloration.
Danish: Hætteglas med fremmedlegemer eller misfarvning må ikke anvendes.
English: Maintenance therapy every 4 weeks (Q4) at the same cumulative dose as the bi-weekly (Q2) dose has been studied in adult patients with stable residual Gaucher disease type 1.
Danish: Vedligeholdelsesbehandling hver 4. uge (Q4) med samme totaldosis som hver 2. uge (Q2) er også blevet undersøgt hos voksne patienter med stabil residual Gauchers sygdom type I. Ændringer i baseline for hæmoglobulin, trombocytter, lever- og miltstørrelse, knoglekriser og knoglesygdom udgjorde prædefinerede sammensatte endpoints.
English: Eighty-nine percent of Q4- and 100% of Q2-treated patients met the therapeutic goals-based endpoint; the difference was not statistically significant based on the 95% CI (-0.231, 0.060).
Danish: Forskellen var ikke statistisk signifikant baseret på 95 % konfidensinterval (-0,231; 0,060).
English: Cerezyme 200 Units powder for concentrate for solution for infusion Each vial contains 200 units* of imiglucerase**.
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 200 enheder* imiglucerase**.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: The product diluted in 0.9%
Danish: Bland derefter den samlede mængde med 0,9 % i.v.
English: Package leaflet: Information for the user Cerezyme 200 Units powder for concentrate for solution for infusion
Danish: Indlægsseddel: Information til brugeren Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning imiglucerase
English: Each vial contains 200 units of imiglucerase.
Danish: Hvert hætteglas indeholder 200 enheder imiglucerase.
English: Cerezyme 400 Units powder for concentrate for solution for infusion Each vial contains 400 units* of imiglucerase**.
Danish: Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 400 enheder* imiglucerase**.
English: Imiglucerase
Danish: Fortynding
English: Package leaflet: Information for the user Cerezyme 400 Units powder for concentrate for solution for infusion
Danish: Indlægsseddel: Information til brugeren Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning imiglucerase
English: Cerezyme 200 Units powder for concentrate for solution for infusion 2 years
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning 2 år.
English: Each vial contains 400 units of imiglucerase.
Danish: Hvert hætteglas indeholder 400 enheder imiglucerase.
English: Cerezyme 200 Units Powder for concentrate for solution for infusion imiglucerase
Danish: Cerezyme 200 Enheder Pulver til koncentrat til infusionsvæske, opløsning imiglucerase
English: Cerezyme 400 Units powder for concentrate for solution for infusion 3 years
Danish: Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning 3 år.
English: MARKETING AUTHORIZATION NUMBERS
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: Sixty-three percent of Q4- and 81% of Q2treated patients met the composite endpoint at Month 24; the difference was not statistically significant based on the 95% CI (-0.357, 0.058).
Danish: Forskellen var ikke statistisk signifikant baseret på 95 % konfidensinterval (-0,357; 0,058).
English: Cerezyme 400 Units Powder for concentrate for solution for infusion imiglucerase
Danish: Cerezyme 400 Enheder Pulver til koncentrat til infusionsvæske, opløsning imiglucerase
English: How Cerezyme is given.
Danish: Sådan skal du bruge Cerezyme
English: Cerezyme 200 Units powder for concentrate for solution for infusion Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Danish: Cerezyme 200 Enheder pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas rekonstitueres med 5,1 ml vand til injektionsvæsker.
English: One vial contains 400 units of imiglucerase.
Danish: Ét hætteglas indeholder 400 E imiglucerase.
English: Cerezyme 400 Units powder for concentrate for solution for infusion Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Danish: Cerezyme 400 Enheder pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas rekonstitueres med 10,2 ml vand til injektionsvæsker.
English: 25 vials of powder for concentrate for solution for infusion.
Danish: 25 hætteglas med pulver til koncentrat til infusionsvæske, opløsning
English: Tabulated list of adverse reactions
Danish: Anafylaktoide reaktioner
English: If you use more Cerezyme than you should
Danish: Hvis du har fået for meget Cerezyme
English: Changes from baseline in hemoglobin, platelets, liver and spleen volumes, bone crisis, and bone disease comprised a predefined composite endpoint; achievement or maintenance of established Gaucher disease therapeutic goals for the hematologic and visceral parameters comprised an additional endpoint.
Danish: Opnåelse og vedligeholdelse af allerede opnåede terapeutiske mål for Gauchers sygdom af hæmatologiske og viscerale parametre var yderligere endpoints.
English: What you need to know before you are given Cerezyme.
Danish: Det skal du vide, før du begynder at bruge Cerezyme Sådan skal du bruge Cerezyme Bivirkninger
English: 1 vial of powder for concentrate for solution for infusion.
Danish: 1 hætteglas med pulver til koncentrat til infusionsvæske, opløsning.
English: Sanofi S.p.A. Tel: +39 059 349 811
Danish: Tel: +39 059 349 811
English: Dilution
Danish: Dosering
English: EU/1/08/494/005 STELARA 130 mg Concentrate for solution for infusion
Danish: EU/1/08/494/005 STELARA 130 mg Koncentrat til infusionsvæske, opløsning
English: Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration
English: 30-100 IU/kg.
Danish: 30-100 IE/kg.
English: • When new information is received that may impact on the current Safety Specification,
Danish: • Når der foreligger nye oplysninger, der kan have indflydelse på den aktuelle sikkerhedsspecifikation,
English: This half-life may vary from patient to patient.
Danish: Halveringstiden kan variere fra patient til patient.
English: In addition, an updated RMP should be submitted
Danish: Derudover skal en opdateret RMP fremsendes
English: The following side effect can be serious and has been observed occasionally.
Danish: Følgende bivirkninger kan være alvorlige og forekommer sommetider.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV
English: The quantity of ImmunoGam you will need will be determined by your doctor or nurse.
Danish: Hvor meget ImmunoGam du skal bruge, fastsættes af lægen eller sygeplejersken.
English: Manufacturer Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
Danish: Cangene Corporation 155 Innovation Drive Winnipeg, MA, Canada R3T 5Y3
English: Pharmacovigilance Plan or risk minimisation activities
Danish: pharmacovigilance-plan eller på risikominimeringsaktiviteter
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Senest 60 dage efter, at en vigtig (pharmacovigilance eller risikominimering) milepæl er nået
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside
English: • Immunoglobulin A: Please tell your doctor if your blood does not have immunoglobulin A (IgA).
Danish: • Immunglobulin A: Fortæl det til lægen, hvis dit blod ikke indeholder immunglobulin A (IgA).
English: • Do not use ImmunoGam after the expiry date which is stated on the label and carton.
Danish: • Brug ikke ImmunoGam efter den udløbsdato, der står på etiketten og pakningen.
English: • Please inform your doctor if you are planning to receive a vaccine or have been recently vaccinated in the last three months.
Danish: • Fortæl det til lægen, hvis du planlægger at blive vaccineret eller er blevet det inden for de seneste tre måneder.
English: - The other ingredients are maltose and polysorbate 80.
Danish: - Øvrige indholdsstoffer: maltose og polysorbat 80.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I henhold til CHMP-vejledningen for risikostyringsprogrammer vedrørende lægemidler til human brug, skal den opdaterede risikostyringsprogram indsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: Your doctor will decide if ImmunoGam can be used during pregnancy and breastfeeding.
Danish: Lægen vil afgøre, om ImmunoGam kan bruges under graviditet og amning.
English: In animals, acute toxicity testing is of no relevance as higher doses result in overloading.
Danish: Undersøgelser for akut toksicitet i dyr er ikke relevante, da højere doser resulterer i overbelastning.
English: ImmunoGam has an elimination half-life of 3 - 4 weeks.
Danish: ImmunoGam har en eliminationshalveringstid på 3-4 uger.
English: Important information about some of the ingredients of ImmunoGam
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i ImmunoGam
English: Effects of the medicinal product on the immune system of the newborn have not been studied.
Danish: Lægemidlets virkning på nyfødtes immunsystem er ikke blevet undersøgt.
English: The immunoglobulin IgG subclasses are:
Danish: Der findes følgende immunglobulin IgG-underklasser:
English: Like all medicines, ImmunoGam can cause side effects, although not everybody gets them.
Danish: ImmunoGam kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Pharmacotherapeutic group: Hepatitis B immunoglobulin, ATC code: J06BB04
Danish: Farmakoterapeutisk klassifikation: Hepatitis B-immunglobulin, ATC-kode: J06BB04
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials.
Danish: Sikkerheden ved gravides brug af dette lægemiddel er ikke blevet påvist i kontrollerede kliniske forsøg.
English: Excipients: Maltose (see package leaflet for further information) and polysorbate 80
Danish: Hjælpestoffer: Maltose (se indlægssedlen for nærmere vejledning) og polysorbat 80
English: However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Danish: Dog skal det bemærkes, at der ikke findes kliniske undersøgelsesdata, der understøtter subkutan indgivelse.
English: You should NOT be given ImmunoGam - if you have previously developed an allergic reaction to human immunoglobulins, to other blood products or to any of the other ingredients of ImmunoGam.
Danish: Brug ikke ImmunoGam - hvis du tidligere har haft allergiske reaktioner på humane immunglobuliner, på andre blodprodukter eller et af de øvrige indholdsstoffer i ImmunoGam.
English: After administration of this medicinal product, an interval of at least 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 med levende svækket virus.
English: • Allergic reaction: There is a chance that you may experience an allergic reaction after administration of this medicine.
Danish: • Allergisk reaktion: Der er en risiko for, at du kan udvikle en allergisk reaktion efter indsprøjtning af medicinen.
English: ImmunoGam contains a small quantity of IgA (less than 40 micrograms/ml).
Danish: ImmunoGam indeholder en lille mængde IgA (mindre end 40 mikrogram/ml).
English: Ask your doctor for advice before using this medicine.
Danish: Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.