FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 October 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Discomfort, Granulomatous lesion
Danish: Granulomatøs læsion
English: Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre.
Danish: Hvert hætteglas med lægemidlet indeholder 4 millioner autologe humane bruskceller i en 0,4 ml cellesuspension svarende til en koncentration på 10.000 celler/mikroliter.
English: This is the case if the biopsy is of insufficient quality to make ChondroCelect, or in some instances, it may be the cells cannot be grown in the laboratory or that the cells after expansion do not meet all the quality requirements Your surgeon will be informed and might have to select an alternative treatment for you.
Danish: I nogle tilfælde kan cellerne ikke dyrkes i laboratoriet, eller efter opformering opfylder alle cellerne ikke alle kvalitetskravene.
English: Anxiety
Danish: Ubehag
English: What ChondroCelect contains - The active substance of ChondroCelect consists of a treatment dose of viable autologous human cartilage cells in vials containing 4 million cells in 0.4 ml, corresponding to a concentration of
Danish: Det aktive stof ChondroCelect består af en behandlingsdosis af levedygtige autologe humane bruskceller i hætteglas indeholdende 4 millioner celler i 0,4 ml svarende til en koncentration på 10.000 celler/mikroliter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 million autologous human cartilage cells in 0.4 ml, corresponding to a concentration of 10,000 cells/microlitre.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 4 millioner autologe humane bruskceller i 0,4 ml svarende til en koncentration på 10.000 celler/mikroliter.
English: Haemarthrosis, Joint instability, Joint stiffness, Loose body in joint, Mobility decreased, Muscle atrophy, Osteoarthritis, Synovial cyst, Synovitis,
Danish: Chondropati Eksostose Hæmartrose Ustabilitet i led Stivhed i led Løs genstand i led Nedsat mobilitet Muskelatrofi Osteoartritis Synovialiscyste Synovitis
English: - If you have any further questions, ask your doctor, surgeon or physical therapist.
Danish: - Spørg lægen, kirurgen eller fysioterapeuten, hvis der er mere, du vil vide.
English: The implantation should be followed by an appropriate rehabilitation schedule for approximately one year, as recommended by the physician (see section 4.4).
Danish: Implantationen bør følges op af en passende genoptræningsplan i ca. et år som anbefalet af
English: The training material for other healthcare professionals shall include the following key messages and components:
Danish: Undervisningsmaterialerne for andet sundhedspersonale skal omfatte følgende centrale
English: What ChondroCelect looks like and contents of the pack ChondroCelect is a cell suspension (a fluid) for implantation.
Danish: ChondroCelect er en cellesuspension (en væske) til implantation.
English: Romeinse straat 12/2 3001 LEUVEN Belgium
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Belgien
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: Fritaget fra krav om brailleskrift
English: Lung embolism
Danish: Lungeemboli
English: Hyperesthesia, Migraine,
Danish: Hyperæstesi Migræne Fotofobi
English: Fat embolism, Thrombophlebitis
Danish: Fedtemboli Tromboflebit
English: The CHMP decided that the MAH should continue to submit 1-yearly PSURs.
Danish: CHMP besluttede, at indehaveren af markedsføringstilladelsen bør fortsætte med at indsende
English: Joint injury, Procedural site reaction
Danish: Reaktion på operationsstedet
English: Deep vein thrombosis, Haematoma, Superficial phlebitis
Danish: Dyb venøs trombose Hæmatom Overfladisk flebit
English: Photophobia, Transient ischaemic attack
Danish: Forbigående iskæmisk anfald
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) of the biological active substance(s) PharmaCell Cell Manufacturing Facility B.V.
Danish: PharmaCell Cell Manufacturing Facility B.V.
English: • Training material for other healthcare professionals
Danish: • Undervisningsmateriale for andet sundhedspersonale • Erklæring om informeret samtykke, som patienter skal underskrive forud for
English: Using fibrin glue only, instead of stitches, to secure the implant is not recommended.
Danish: Det frarådes kun at bruge fibrinklæber frem for
English: • Additional risk minimisation measures
Danish: • Risikostyringsplan (RMP)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
English: If you have any further questions on the use of this medicine, ask your doctor or physical therapist.
Danish: Spørg lægen eller fysioterapeuten, hvis der er mere, du vil vide om behandlingen med
English: Hypersensitivity to any of the excipients listed in section 6.1, or to bovine serum.
Danish: Overfølsomhed over for et eller flere af hjælpestofferne anført i pkt.
English: Falcon tube
Danish: Mave-tarm-kanalen
English: Please tell your doctor or physical therapist if you are taking, have recently taken or might take any other medicines.
Danish: Tal med lægen eller fysioterapeuten, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: 4.3 Contraindications
Danish: 6.3 Opbevaringstid
English: Musculoskeletal and connective tissue disorders
Danish: Artofibrose Begrænset bevægelighed af led Ledeffusion Fastlåst led Artritis
English: Gastrointestinal disorders
Danish: Transplantatkomplikati oner
English: - If you get any of the side effects, talk to your doctor, surgeon or physical therapist.
Danish: - Tal med lægen, kirurgen eller fysioterapeuten, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Posology
Danish: Ledskade
English: Arthritis,
Danish: Artropati
English: • if you are pregnant.
Danish: • hvis du er gravid.
English: These hormones can be measured in your blood.
Danish: Disse hormoner kan måles i dit blod.
English: Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
Danish: Dato for første tilladelse: 9. marts 2000 Dato for fornyelse af tilladelsen: 9. marts 2010
English: In addition, no patient had a definitive recurrence during the 3.7 years of follow-up.
Danish: Derudover havde ingen af patienterne definitivt recidiv i løbet af opfølgningsperioden på 3,7 år.
English: It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Danish: Det er vigtigt at bemærke, at den mikrobiologiske sikkerhed afhænger af de aseptiske forhold under tilberedningen af opløsningen.
English: A follow-up study was conducted on patients who previously completed the initial study, and data is available for 51 patients.
Danish: Et opfølgende studie blev udført med patienter, der tidligere havde gennemført det initiale studie, og data er tilgængelige for 51 patienter.
English: <PC: SN:
Danish: PC: SN: NN:
English: This may lead to increased risk of headache and nausea.
Danish: Dette kan medføre øget risiko for hovedpine og kvalme.
English: A risk to the suckling child cannot be excluded.
Danish: Risiko for det ammede barn kan ikke udelukkes.
English: It is comprised of two non-covalently linked subunits.
Danish: Det består af to ikkekovalentforbundne underenheder.
English: Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.
Danish: Data om eksponering over den anbefalede dosis er begrænsede til kliniske studier og et specielt behandlingsprogram.
English: Pre-therapeutic stimulation
Danish: Præ-terapeutisk stimulering
English: Do not take Thyrogen if you are pregnant.
Danish: Du må ikke tage Thyrogen, hvis du er gravid.
English: • if you have reduced liver function; you should still be able to receive Thyrogen.
Danish: • hvis du har nedsat leverfunktion; du burde stadig kunne få Thyrogen.
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler vedrørende bortskaffelse.
English: In clinical trials this was not seen.
Danish: Det er dog ikke konstateret ved kliniske forsøg.
English: The elimination halflife was 22 ± 9 hours.
Danish: Halveringstiden for udskillelsen var 22 ± 9 timer.
English: No special precautions for elderly patients are necessary.
Danish: Der er ingen særlige forholdsregler for ældre.
English: ATC code for thyrotropin alfa: H01AB01
Danish: ATC-kode for thyrotropin alfa: H01AB01
English: • pain (including pain at the site of metastases (secondary cancer growths))
Danish: • smerter (inklusive smerter i metastaseområder (sekundær kræftvækst))
English: Swirl the contents of the vial gently until all material is dissolved.
Danish: Hætteglassets indhold hvirvles forsigtigt rundt, indtil alt materialet er opløst.
English: The median follow-up was 6.5 years (4.5 to 7.6 years).
Danish: Gennemsnitlig opfølgningsperiode var 6,5 år (4,5 til 7,6 år).
English: The median follow-up was 5.4 years (0.5 to 9.2 years).
Danish: Gennemsnitlig opfølgningsperiode var 5,4 år (0,5 til 9,2 år).
English: Post-treatment scanning may be delayed a few days to allow background radioactivity to decline.
Danish: Scanningen efter behandlingen kan forsinkes nogle få dage for, at baggrundsstrålingen kan falde.
English: Your doctor will decide if you belong to a specific group of patients for which pre-treatment with corticosteroids is to be considered (for example, if you have secondary cancer growths in your brain or spinal cord).
Danish: Lægen vil afgøre, om du hører til en bestemt gruppe patienter, for hvem en forbehandling med steroider bør overvejes (for eksempel hvis du har sekundær kræftvækst i din hjerne eller rygmarv).
English: False negative results may occur with Thyrogen.
Danish: Falske negative resultater kan forekomme med Thyrogen.
English: The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
Danish: De almindeligst indberettede bivirkninger er kvalme og hovedpine, som opstår hos cirka hhv. 11% og 6% af patienterne.
English: Diagnostic use
Danish: Diagnostisk anvendelse
English: Breast-feeding should only be resumed following advice from your doctor.
Danish: Amning bør kun genoptages efter rådføring med lægen.
English: Overall, 48/51 patients (94%) had no evidence of cancer recurrence, 1 patient had possible cancer recurrence (although it was not clear whether this patient had a true recurrence or persistent tumour from the regional disease noted at the start of the original study), and 2 patients could not be assessed.
Danish: Samlet set havde 48/51 patienter (94 %) ikke evidens for cancerrecidiv, 1 patient havde muligt cancerrecidiv (selvom det ikke var klart, om denne patient havde ægte recidiv eller persisterende tumor pga. den lokale sygdom, der bemærkedes i starten af det initiale studie), og 2 patienter kunne ikke vurderes.
English: If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered.
Danish: Hvis der fortsat er stærk mistanke om metastatisk sygdom, bør man overveje en bekræftende indstilling af WBS- og Tg-undersøgelsen.
English: HR: 1.10 [95% CI 0.47 - 2.59]; p=0.83
Danish: HR: 1,10 [95 % KI 0,47 - 2,59]; p=0,83
English: It is unknown whether thyrotropin alfa /metabolites are excreted in human milk.
Danish: Det vides ikke, om thyrotropin alfa/metabolitter udskilles i human mælk.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden for rapportering klassificeres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden
English: Your child's doctor will help you decide if Thyrogen should be given to your child.
Danish: Barnets læge vil hjælpe dig med at beslutte, om dit barn bør få Thyrogen.
English: Analyses of T3 patients and N1 patients showed that these subgroups had equally good ablation success rates as did lower-risk patients.
Danish: Analyser af T3-patienter og N1-patienter viste, at hyppigheden for vellykket ablation i disse undergrupper var lige så stor som hos patienter med lavere risiko.
English: Therefore, both TgAb and Tg assays are needed.
Danish: Derfor er det nødvendigt at udføre både TgAb- og Tg-analyser.
English: Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Danish: På grund af manglende oplysninger om brugen af Thyrogen til børn, bør Thyrogen kun anvendes til børn under helt specielle omstændigheder.
English: Thyrogen may reduce the ability to drive or use machines, since dizziness and headaches have been reported.
Danish: Thyrogen kan reducere evnen til at køre eller betjene maskiner, da svimmelhed og hovedpine er blevet rapporteret.
English: Effect on tumour growth and/or size
Danish: Indvirkning på tumorvækst og/eller -størrelse:
English: The Thyrogen solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2°C and 8°C).
Danish: Thyrogen-opløsningen bør injiceres inden for tre timer, omend Thyrogen-opløsningen vil forblive kemisk stabil i op til 24 timer, hvis den opbevares i køleskab (mellem 2°C og 8°C).
English: Infections and infestations influenza
Danish: Infektioner og parasitære sygdomme influenza
English: For the ESTIMABL1 study, 726 (97%) of the original 752 patients were followed up for disease recurrence.
Danish: I ESTIMABL1-studiet blev 726 (97 %) af de oprindelige 752 patienter fulgt for sygdomsrecidiv.
English: Unopened vials 3 years.
Danish: Uåbnede hætteglas 3 år.
English: Non-clinical data are limited, but reveal no special hazard for humans from use of Thyrogen.
Danish: De prækliniske data er begrænsede, men viser ingen særlig risiko for mennesker som følge af brug af Thyrogen.
English: Patients were still considered to be successfully ablated if there was no visible thyroid bed uptake on the scan, or if visible, uptake was less than 0.1%.
Danish: Ablation af patienterne blev anset som vellykket, hvis der ikke var synlig thyroidea-optagelse ved scanningen, eller hvis synlig, at optagelsen var mindre end 0,1 %.
English: The tables below provide long term follow up information for the ESTIMABL1 and HiLo studies
Danish: Nedenstående tabeller viser langtidsopfølgningsdata for ESTIMABL1- og HiLo-studiet.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkninger vist i rækkefølge efter faldende alvorlighed.
English: In clinical trials involving 481 patients, no patients have developed antibodies to thyrotropin alfa either after single or repeated limited (27 patients) use of the product.
Danish: I kliniske undersøgelser med 481 patienter udviklede ingen patienter antistoffer mod thyrotropin alfa hverken ved brug en enkelt gang eller efter gentagen, begrænset brug af lægemidlet (27 patienter).
English: For the HiLo study, 434 (99%) of the original 438 patients were followed up for disease recurrence.
Danish: I HiLo-studiet blev 434 (99 %) af de oprindelige 438 patienter fulgt op for sygdomsrecidiv.
English: Thyrogen must not be mixed with other medicines in the same injection.
Danish: Thyrogen må ikke blandes med andre lægemidler i samme injektionssprøjte.
English: However if your thyroid gland has not been removed completely and you are also suffering from heart disease, your doctor will help you decide if Thyrogen should be given to you.
Danish: Men hvis din skjoldbruskkirtel ikke er fjernet helt, og du også lider af en hjertesygdom, vil din læge hjælpe dig med at beslutte, om du skal have Thyrogen.
English: Thyrogen contains sodium, see section 2.
Danish: Thyrogen indeholder natrium, se punkt 2.
English: When the powder is dissolved the total volume in the vial is 1.2 ml.
Danish: Når pulveret er opløst, er det samlede volumen i hætteglasset 1,2 ml.
English: Very common (may affect more than 1 in 10 people): • nausea
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): • kvalme
English: Use aseptic technique.
Danish: Anvend aseptisk teknik.
English: Formal interaction studies between Thyrogen and other medicinal products have not been performed.
Danish: Der er ikke udført nogen formelle interaktionsundersøgelser mellem Thyrogen og andre lægemidler.
English: In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
Danish: Hos patienter med signifikant nyreinsufficiens skal aktiviteten af radioaktivt iod nøje fastsættes af nuklearmediciner.
English: The use of Thyrogen in patients with reduced liver function does not warrant special considerations.
Danish: Anvendelse af Thyrogen til patienter med nedsat leverfunktion kræver ikke særlige forholdsregler.
English: In summary, these studies support the efficacy of low activity radioiodine plus thyrotropin alpha (with reduced radiation exposure).
Danish: Sammenfattende understøtter disse studier effekten af radioaktivt iod med lav aktivitet plus thyrotropin alfa (med nedsat stråleeksponering).
English: In one of the studies, two dose regimens were examined: 0.9 mg intramuscular every 24 hours for two doses (0.9 mg x 2) and 0.9 mg intramuscular every 72 hours for three doses (0.9 mg x 3).
Danish: I en af undersøgelserne blev to doseringsprincipper undersøgt: 0,9 mg intramuskulær for hver 24 timer for to doser (0,9 mg x 2) og 0,9 mg intramuskulær for hver 72 timer for tre doser (0,9 mg x 3).
English: This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Danish: Det menes at være relateret til de forhøjede niveauer af thyroideastimulerende hormon (TSH) over en længere periode.
English: Thyrogen-stimulated thyroglobulin testing was also performed.
Danish: Thyrogen-stimuleret thyroglobulin blev også målt.
English: Based on 684 evaluable patients, the overall ablation success rate assessed by neck ultrasounds and stimulated Tg levels was 92%, without any statistically significant difference among the four groups.
Danish: Baseret på 684 evaluerbare patienter var den samlede hyppighed for vellykket ablation vurderet ved ultralyd af hals og stimulerede Tg-niveauer 92 % uden nogen statistisk signifikant forskel mellem de fire grupper.
English: The third patient experienced nausea, vomiting and hot flushes after 3.6 mg IM dose.
Danish: Den tredje patient oplevede kvalme, opkastning og hedeture efter en dosis på 3.6 mg IM.
English: Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes.
Danish: Resultater fra kontrollerede forsøg tyder på, at der ikke er nogen forskel mellem voksne patienter på under 65 år og over 65 år med hensyn til Thyrogens sikkerhed og virkeevne, når Thyrogen anvendes til diagnostiske formål.
English: Three patients in clinical trials and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended.
Danish: Tre patienter i kliniske forsøg og en patient i det specielle behandlingsprogram fik symptomer efter at have modtaget højere Thyrogen doser end de anbefalede.
English: The following effects have been reported with Thyrogen:
Danish: Følgende bivirkninger er rapporteret med Thyrogen:
English: Two patients had nausea after 2.7 mg IM dose, and in one of these patients nausea was also accompanied by weakness, dizziness and headache.
Danish: To personer fik kvalme efter en 2.7 mg IM dosis, og en af disse patienter oplevede også svaghed, svimmelhed og hovedpine.
English: A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
Danish: En foreslået behandlingsform ved overdosering ville være at genetablere væskebalancen, og det kan også overvejes at indgive et antiemetikum.
English: There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population.
Danish: Der foreligger ingen undersøgelser af alternative dosisregimer for Thyrogen til patienter med ESRD, der kan benyttes som vejledning for dosisreduktion hos denne population.
English: The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Danish: Forekomst af Tg-antistoffer (TgAb) kan forventes hos 18-40% af patienter med differentieret thyroideakræft og kan medføre falske negative serum Tg-målinger.
English: No dose adjustment is necessary in elderly (see section 4.4).
Danish: Ingen dosisjustering er påkrævet hos ældre (se pkt.
English: If the metastases are present in narrow spaces e.g. intracerebral (in the brain) or in the spinal cord, patients could experience symptoms which can occur quickly such as partial paralysis affecting one side of the body (hemiparesis), breathing problems or loss of vision.
Danish: Hvis metastaserne sidder i snævre områder, f.eks. i hjernen (intracerebralt) eller i rygmarven, kan patienterne opleve symptomer, der kan opstå hurtigt, såsom delvis lammelse, der påvirker den ene side af kroppen (hemiparese), åndedrætsproblemer eller synstab.
English: The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded.
Danish: Forekomsten af antistoffer, der eventuelt kan påvirke de endogene TSH-analyser udført under regelmæssige opfølgninger, kan ikke udelukkes.
English: This may lead to acute symptoms, which depend on the anatomical location of the tissue.
Danish: Dette kan medføre akutte symptomer, som afhænger af vævets anatomiske placering.
English: • if you are allergic to bovine or human thyroid stimulating hormone (TSH) or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for thyroideastimulerende hormon (TSH) på okse- eller menneskebasis eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: What you need to know before you use Thyrogen 3.
Danish: Det skal du vide, før du begynder at bruge Thyrogen 3.
English: It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Danish: Det anbefales, at forudgående behandling med kortikosteroider overvejes til patienter, hos hvem lokal tumor-ekspansion eventuelt kan skade vitale anatomiske strukturer.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Thyrogen, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: 45, 51, 68, 74, 76 and 80 New York Avenue Framingham, MA 01701
Danish: Genzyme Corporation 45, 51, 68, 74, 76 and 80 New York Avenue Framingham,
English: High activity dose RAI (3.7 GBq)
Danish: RAI med høj aktivitet (3,7 GBq)
English: The cDNAs encode for an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site.
Danish: cDNA-kodningen giver en alpha-underenhed på 92 aminosyrerester, der indeholder to N-forbundne glycosylation-steder, og en beta-underenhed på 118 rester indeholdende ét N-forbundet glycosylation-sted.
English: It is not recommended to perform TSH assays after Thyrogen administration.
Danish: Det anbefales ikke at udføre TSH-analyser efter administration af Thyrogen.
English: Thyrogen does not contain preservatives.
Danish: Thyrogen indeholder ingen konserveringsmidler.