FrancophonIA/ELRC3.0 huggingface dataset:
English: It is possible that Thyrogen may also cause tumour growth.
Danish: Det er muligt, at Thyrogen også kan forårsage tumorvækst.
English: Clear Type I glass 5 ml vials.
Danish: Gennemsigtige 5 ml hætteglas (Type I).
English: After injection, the mean peak (Cmax) level obtained was 116 ± 38 mU/l and occurred approximately 13 ± 8 hours after administration.
Danish: Efter injektionen var middelværdien for højeste koncentration (Cmax) 116 ± 38mU/l, hvilket opstod ca. 13 ± 8 timer efter indgivelsen.
English: The Thyrogen solution should be a clear, colourless solution.
Danish: Thyrogen-opløsningen bør være en klar, farveløs væske.
English: Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes.
Danish: Thyrogen er et humant thyroidea-stimulerende hormon (TSH), som er fremstillet via bioteknologiske processer.
English: The standard approach to achieve elevated TSH levels has been to withdraw patients from thyroid hormone suppression therapy (THST), which usually causes patients to experience the signs and symptoms of hypothyroidism.
Danish: Standardfremgangsmåden for at opnå høje TSH-niveauer har været at tage patienter ud af thyroideahormonhæmmende terapi (THST), hvilket almindeligvis får patienter til at vise tegn og symptomer på hypotyroidisme.
English: The success of thyroid remnant ablation also was assessed by the criterion of Thyrogen-stimulated serum Tg level < 2 ng/ml eight months after ablation, but only in patients who were negative for interfering anti-Tg antibodies.
Danish: Succesen for ablation af thyroidea-rester blev også vurderet efter kriteriet Thyrogen-stimuleret serum Tg-niveau < 2 ng/ml 8 måneder efter ablation, men kun for patienter, der var negative for interfererende anti-Tg antistoffer.
English: Thyrogen (N=374) THW (N=378)
Danish: Thyrogen (N=374) Seponering af thyroideahormon (N=378)
English: In these studies the use of thyroglobulin testing on Thyrogen was found to be more sensitive than thyroglobulin testing on TSHT.
Danish: I disse undersøgelser konstateredes det, at brugen af thyroglobulin-undersøgelse på Thyrogen var mere følsom end thyroglobulin-undersøgelsen på TSHT.
English: Pack sizes: one or two vials of Thyrogen per carton.
Danish: Pakningsstørrelser: en eller to Thyrogen-hætteglas pr. karton.
English: There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.
Danish: Der er ingen kendte lægemiddelinteraktioner med Thyrogen og de thyroideahormoner, du måske får.
English: Thyrogen-stimulated thyroglobulin levels were above 2 ng/ml in all 35 patients, whereas, thyroglobulin on THST was above 2 ng/ml in 79% of these patients.
Danish: Thyrogen-stimulerede thyroglobulin-niveauer var over 2 ng/ml hos alle 35 patienter, medens thyroglobulin ved THST var over 2 ng/ml hos 79% af disse patienter.
English: One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging.
Danish: En af virkningerne er, at det stimulerer eventuelt resterende skjoldbruskkirtel-væv til at optage iod, hvilket er vigtigt for billeddannelse med radioaktivt iod.
English: Appel depuis l'étranger: +33 1 57 63 23 23
Danish: Appel depuis l'etranger: +33 1 57 63 23 23
English: Pregnancy Animal reproduction studies have not been conducted with Thyrogen.
Danish: Graviditet Der er ikke foretaget reproduktionsundersøgelser af Thyrogen i dyr.
English: All 95% confidence intervals for the differences were within ±10 percentage points, indicating in particular non-inferiority of the low to the high radioiodineactivity.
Danish: Alle 95 %-konfidensintervallerne for angivelse af forskel var indenfor ± 10 %point, indikerende non-inferioritet af radioaktivt iod med lav aktivitet over for radioaktivt iod med høj aktivitet.
English: Do not use this medicine if you notice foreign particles, cloudiness or discoloration.
Danish: Du må ikke bruge denne medicin, hvis du får øje på fremmedlegemer, uklarheder eller misfarvning.
English: Your doctor will determine the exact activity of radioiodine to use for radioiodine imaging, taking into consideration the fact that you continue to take thyroid hormones.
Danish: Lægen vil bestemme den nøjagtige aktivitet af radioaktivt iod, der skal bruges til billeddannelse og tage hensyn til, at du fortsat tager thyroideahormoner.
English: This patient received 0.3 mg of Thyrogen as a single intravenous (IV) bolus and, 15 minutes later experienced severe nausea, vomiting, diaphoresis, hypotension and tachycardia.
Danish: Denne patient modtog 0,3 mg Thyrogen som en enkelt intravenøs (IV) bolusinjektion, og oplevede efter 15 minutter alvorlig kvalme, opkast, diaforese, hypotension og takykardi.
English: Diagnostic scintigraphy should be performed 48 to 72 hours following radioiodine administration, whereas post-ablation scintigraphy may be delayed additional days to allow background activity to decline.
Danish: Diagnostisk scintigrafi skal foretages 48 til 72 timer efter administration af radioaktivt iod, mens scintigrafi efter ablation kan udskydes nogle dage, for at baggrundsstrålingen skal have lejlighed til at falde.
English: Dispose of any unused solution immediately.
Danish: Ikke anvendt opløsning skal omgående bortskaffes.
English: In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Danish: Ved kliniske forsøg med thyrotropin alfa, der forårsagede kortvarige stigninger i mængden af TSH, er der ikke rapporteret nogen tilfælde af tumorvækst.
English: Quality of life was significantly reduced following thyroid hormone withdrawal, but maintained following either dosage regimen of Thyrogen in both indications.
Danish: Livskvaliteten blev væsentligt reduceret efter seponering af thyroideahormoner, men blev bibeholdt efter begge Thyrogen-doseringsprincipper for begge indikationer.
English: For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases.
Danish: F.eks. er hemiplegi, hemiparese eller synstab forekommet hos patienter med CNS-metastaser.
English: Data on radioiodine kinetics indicate that the clearance of radioiodine is approximately 50% greater while euthyroid than during the hypothyroid state when renal function is decreased, thus resulting in less radioiodine retention in the body at the time of imaging.
Danish: Kinetik data for radioaktivt iod viser, at fjernelsen af radioaktivt iod er ca. 50% større, mens patienten er euthyreoid, end i den hypothyreoide tilstand, hvor nyrefunktionen er nedsat, hvorved der fastholdes mindre radioaktivt iod i kroppen, når scanningen foretages.
English: The HiLo study randomised 438 patients (tumour stages T1-T3, Nx, N0 and N1, M0) at 29 centres.
Danish: HiLo-studiet randomiserede 438 patienter (tumorstadier T1-T3, Nx, N0 og N1, M0) på 29 centre.
English: In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Danish: Patienter med veldifferentieret thyroideakræft får foretaget en næsten total eller total tyroidektomi.
English: These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms.
Danish: Disse reaktioner bestod i urticaria, udslæt, pruritus, rødmen og respiratoriske tegn og symptomer.
English: All 28 patients (100%) treated after withdrawal of THST and all 32 patients (100%) treated after Thyrogen administration had either no visible uptake of radioiodine in the thyroid bed or, if visible, thyroid bed uptake <0.1% of the administered activity of radioiodine.
Danish: Alle 28 patienter (100%), der blev behandlet efter seponering af THST, og alle 32 patienter (100%), der blev behandlet efter indgivelse af Thyrogen, havde enten ingen synlig optagelse af radioiod i thyroidea-underlaget eller, hvis den var synlig, en optagelse i thyroidea-underlaget på <0,1% af den indgivne aktivitet af radioiod.
English: The main objective of the follow-up study was to confirm the status of thyroid remnant ablation by using Thyrogen-stimulated radioiodine static neck imaging after a median follow-up of 3.7 years (range 3.4 to 4.4 years) following radioiodine ablation.
Danish: Det vigtigste mål med opfølgningsforsøget var at bekræfte status for ablation af thyroidearester med Thyrogen-stimuleret radioiod ved billeddiagnostik af fikseret hals ved en kontrolundersøgelse efter gennemsnitligt 3,7 år (mellem 3,4 og 4,4 år) efter ablation med radioiod.
English: The adverse reactions mentioned in the table, combine adverse reactions in the six prospective clinical trials (N=481) and undesirable effects that have been reported to Genzyme after licensure of Thyrogen.
Danish: Bivirkningerne anført i tabellen omfatter bivirkninger fra de seks prospektive kliniske undersøgelser (N=481) og bivirkninger, der er blevet rapporteret til Genzyme efter godkendelse af Thyrogen.
English: Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Low activity dose RAI (1.1 GBq)
Danish: RAI med lav aktivitet (1,1 GBq)
English: As assessed by radioiodine imaging and stimulated Tg levels (n = 421), ablation success rates were approximately 86% in all four treatment groups.
Danish: Vurderet ved scanning med radioaktivt iod og stimulerede Tg-niveauer (n = 421) var hyppigheden for vellykket ablation ca. 86 % i alle fire behandlingsgrupper.
English: Metastatic disease was confirmed by a post-treatment scan or by lymph node biopsy in 35 patients.
Danish: Metastaser blev bekræftet ved scanning eller lymfeknudebiopsi efter behandlingen hos 35 patienter.
English: After reconstitution, the solution should be injected within three hours.
Danish: Efter rekonstitution skal opløsningen injiceres inden for tre timer.
English: This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging.
Danish: Der bør tages hensyn til denne faktor ved valg af det aktivitetsniveau for radioaktivt iod, der skal anvendes i scanningen med radioaktivt iod.
English: Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 ± 1 months after treatment.
Danish: Succesraten for ablation af rester blev vurderet ved imagografi med radioiod og med serum thyroglobulin-undersøgelse 8 ± 1 måneder efter behandling.
English: Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.
Danish: Din læge eller sygeplejerske vil injicere 1,0 ml Thyrogen-opløsning.
English: Package size: one or two vials per carton.
Danish: Pakninger: en eller to hætteglas pr. karton.
English: Patients studied were adults (>18 years), with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterised, principally (54 of 60), as T1-T2, N0-N1, M0 (TNM classification).
Danish: De undersøgte patienter var voksne (> 18 år) med netop diagnosticeret papillært eller follikulært thyroideakarcinom, herunder også papillær-follikulær-varianten, primært karakteriseret (54 ud af 60) som T1-T2, N0-N1, M0 (TNM-klassifikation.)
English: Specifically in a Phase III study involving 164 patients the detection rate of tissue of thyroid origin after a Thyrogen thyroglobulin test ranged from 73-87%, whereas, by using thyroglobulin on TSHT it was 42-62% for the same cut-off values and comparable reference standards.
Danish: I en Fase III undersøgelse med deltagelse af 164 patienter lå detektionsraten for thyroidholdigt væv efter Thyrogen thyroglobulin test på 7387%, mens der ved brug af thyroglobulin på TSHT var 42-62% for de samme grænseværdier og tilsvarende referencestandarder.
English: Thyrogen powder must be dissolved in water for injection.
Danish: Thyrogenpulver skal opløses i vand til injektionsvæsker.
English: The reconstituted solution can be stored for up to 24 hours in a refrigerator (2°C - 8°C) under protection from light, while avoiding microbial contamination.
Danish: Den rekonstituerede opløsning kan opbevares i op til 24 timer i køleskab (2°C - 8°C) beskyttet mod lys og mikrobiel forurening.
English: Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
Danish: Larynxødem, respirationsbesvær, der kræver trakeotomi, og smerter ved metastaserne er også rapporteret efter indgivelse af Thyrogen.
English: Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue.
Danish: Derfor skal de individuelle fordele og ulemper nøje vurderes for patienter med signifikante rester af thyriodea-væv.
English: The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Danish: Thyrogens farmakokinetiske egenskaber blev undersøgt i patienter med veldifferentieret thyroideacancer efter en enkelt 0,9 mg intramuskulær injektion.
English: One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Danish: En patient som deltog i et klinisk forsøg fik symptomer efter at have modtaget intravenøst Thyrogen.
English: Careful evaluation of benefit-risk relationships should be assessed for Thyrogen administration in high risk elderly patients who have heart disease (e.g. valvular heart disease, cardiomyopathy, coronary artery disease, and prior or current tachyarrhythmia including atrial fibrillation) and have not undergone thyroidectomy.
Danish: Der bør foretages en nøje vurdering af forholdet mellem fordele og risici for Thyrogen-administration til ældre patienter i højrisikogruppen, som har en hjertesygdom (f.eks. klapfejl, kardiomyopati, koronararteriesygdom samt tidligere eller aktuel takyarytmi inklusive atrieflimren), og som ikke har fået foretaget thyroidektomi.
English: Information from post marketing surveillance, as well as published information, suggests that elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of thyroid stimulating hormone (TSH) levels for several days after treatment.
Danish: Informationer fra overvågning efter markedsføring såvel som publicerede informationer tyder på, at udskillelsen af Thyrogen sker betydeligt langsommere hos dialysepatienter med terminal nyresygdom (ESRD), hvilket medfører længerevarende forhøjede niveauer af thyroideastimulerende hormon (TSH) i flere dage efter behandlingen.
English: Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Danish: Thyrotropin alfa (rekombinant human thyroideastimulerende hormon) er et heterodimerisk glycoprotein, der produceres ved en rekombinant DNA-teknologi.
English: To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Danish: For at opnå en tilstrækkelig mængde til nøjagtig dispensering indeholder hvert hætteglas med Thyrogen en overfyldning på 0,2 ml.
English: It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left.
Danish: Det stimulerer også dannelsen af thyroglobulin og thyroidea-hormoner, hvis der er noget skjoldbruskvæv tilbage.
English: All patients considered ablated in the initial study were confirmed to be ablated in the follow-up study.
Danish: For alle patienter, hvis ablation blev vurderet som vellykket i det første forsøg, blev ablationen bekræftet som vellykket i opfølgningsforsøget.
English: Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen).
Danish: Diagnostisk scanning skal gennemføres 48 til 72 timer efter administration af det radioaktive iod (72 til 96 timer efter den sidste Thyrogen-injektion).
English: Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings.
Danish: Usædvanlige tilfælde af overfølsomhed er konstateret i både kliniske undersøgelser og efter markedsføring.
English: Two large prospective randomised studies, the HiLo study (Mallick) and the ESTIMABL1 study (Schlumberger), compared methods of thyroid remnant ablation in patients with differentiated thyroid cancer who had been thyroidectomised.
Danish: To store prospektive randomiserede studier, HiLo-studiet (Mallick) og ESTIMABL1-studiet (Schlumberger), sammenlignede metoder til ablation af thyroideavæv hos patienter med differentieret thyroideacancer, der havde fået fjernet skjoldbruskkirtlen.
English: Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen.
Danish: Forstørrelse af resterende thyroideavæv eller metastaser kan forekomme efter behandling med Thyrogen.
English: Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues.
Danish: Farmakoterapeutisk klassifikation: Hypofyse- og hypothalamushormoner og analoger, Hypofyselap hormoner og analoger.
English: - If you experience any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: It is recommended that the Thyrogen solution be injected within three hours.
Danish: Det anbefales at injicere Thyrogen-opløsningen inden for tre timer.
English: In the absence of compatibility studies, this medicinal product must not be administered as a mixture with other medicinal products in the same injection.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity.
Danish: Det vides ikke, om Thyrogen kan forårsage fosterskader ved indgivelse til gravide kvinder, eller om det kan påvirke fertiliteten.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodiumfree'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. injektion, dvs. den er i det væsentlige natriumfri.
English: There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth.
Danish: Der er en teoretisk mulighed for, at Thyrogen, ligesom seponering af thyroideahormon, kan medføre stimulation af tumorvækst.
English: Using this Tg criterion, 18/21 patients (86%) and 23/24 patients (96%) had thyroid remnants successfully ablated in the THST withdrawal group and the Thyrogen treatment group, respectively.
Danish: Ved brug af dette Tg-kriterium var ablation af thyroidea-rester vellykket hos henholdsvis 18/21 patienter (86%) og 23/24 patienter (96%) i gruppen med THST og Thyrogen-behandlingsgruppen.
English: Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rhTSH-stimulated Tg levels.
Danish: Lavrisiko-patienter med veldifferentieret thyroideacancer, der har ikke-sporbare Tg-niveauer i serum ved THST og ingen rh(rekombinant human)TSH-stimuleret forøgelse af Tg-niveauer, kan følges op ved analyse af rhTSH-stimulerede Tg-niveauer.
English: Intramuscular injection only.
Danish: Kun til intramuskulær injektion.
English: Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Thyrogen
English: Effect on tumour growth
Danish: Indvirkning på tumorvækst
English: Use aseptic technique
Danish: Anvend aseptisk teknik
English: The ESTIMABL1 study randomised 752 patients with low-risk thyroid cancer (tumour stages pT1 < 1 cm and N1 or Nx, pT1 >1-2 cm and any N stage, or pT2 N0, all patients M0) at 24 centres.
Danish: ESTIMABL1-studiet randomiserede 752 patienter med thyroideacancer med lav risiko (tumorstadier pT1 < 1 cm og N1 eller Nx, pT1 >1-2 cm og ethvert N-stadie, eller pT2 N0, alle patienter M0) på 24 centre.
English: • impaired sense of taste (dysgeusia)
Danish: • nedsat smagssans (dysgeusi)
English: Due to elevation of TSH levels after Thyrogen, patients with secondary cancer growths (metastases) can experience local swelling or bleeding at the site of these metastases which may become bigger.
Danish: På grund af forhøjede TSH-niveauer efter brug af Thyrogen kan patienter med metastaser (kræft, der har spredt sig) opleve lokal hævelse eller blødning på stedet for disse metastaser, som kan vokse.
English: Recurrence rate (3 years)
Danish: Recidivrate (7 år)
English: In clinical trials, for the detection of thyroid remnants or cancer in ablated patients using a thyroglobulin assay with a lower limit of detection of 0.5 ng/ml, Thyrogen-stimulated thyroglobulin levels of 3 ng/ml, 2 ng/ml and 1 ng/ml corresponded with thyroglobulin levels after withdrawal of thyroid hormone of 10 ng/ml, 5 ng/ml and 2 ng/ml, respectively.
Danish: Ved udførelse af kliniske forsøg med henblik på detektion af rester af thyroidea eller -kræft i ablaterede patienter ved hjælp af en thyroglobulinanalyse med en nedre detektionsgrænse på 0,5 ng/ml, svarede Thyrogen-stimulerede thyroglobulin-niveauer på 3 ng/ml, 2 ng/ml og 1 ng/ml til thyroglobulin-niveauerne efter seponering af thyroideahormon på henholdsvis 10 ng/ml, 5 ng/ml og 2 ng/ml.
English: In the special treatment program, a 77 year-old patient with metastatic thyroid cancer who had not been thyroidectomised received 4 doses of Thyrogen 0.9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later.
Danish: En 77-årig patient med metastatisk kræft i skjoldbruskkirtlen, som ikke havde fået fjernet skjoldbruskkirtlen, modtog 4 doser 0,9 mg Thyrogen i løbet af 6 dage gennem det specielle behandlingsprogram og udviklede atrieflimren, hjertedekompensation og terminal myokardieinfarkt 2 dage senere.
English: Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
Danish: Kontrollér visuelt Thyrogen-opløsningen i hætteglasset for fremmedlegemer og misfarvning.
English: Binding of thyrotropin alfa to TSH receptors on thyroid epithelial cells stimulates iodine uptake and organification, and synthesis and release of thyroglobulin, triiodothyronine (T3) and thyroxine (T4).
Danish: Når thyrotropin alfa bindes til TSH receptorer på thyroidea epithelialceller, stimuleres iodoptagelsen og organificeringen samt syntesen og afgivelsen af thyroglobulin, triiodothyronin (T3) og thyroxin (T4).
English: The major elimination route of thyrotropin alfa is believed to be renal and to a lesser extent hepatic.
Danish: Den vigtigste udskillelsesvej for thyrotropin alfa menes at være gennem nyrerne og i mindre grad gennem leveren.
English: Thyrogen contains the active substance thyrotropin alfa.
Danish: Thyrogen indeholder det aktive stof thyrotropin alfa.
English: Both dose regimens improved the sensitivity, accuracy and negative predictive value of Thyrogen-stimulated thyroglobulin alone or in combination with radioiodine imaging as compared to testing performed while patients remained on thyroid hormones.
Danish: Begge doseringsprincipper forbedrede sensitiviteten, nøjagtigheden og den negative forventede (prædiktive) værdi af Thyrogen-stimuleret thyroglobulin alene eller i kombination med scanning med radioaktivt iod sammenlignet med undersøgelser, der blev udført, mens patienterne blev behandlet med thyroideahormoner.
English: General disorders and administration site conditions fatigue, asthenia influenza like illness, pyrexia, chills, feeling hot discomfort, pain, pruritus, rash and urticaria at the site of injection
Danish: Almene symptomer og reaktioner på administrationsstedet træthed, asteni influenzalignende sygdom, pyreksi, kulderystelser, varmefølelse ubehag, smerter, pruritus, udslæt og urticaria ved injektionsstedet