FrancophonIA/ELRC3.0 huggingface dataset:
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tkun stmata mid-data disponibbli)
English: HR: 1.62 [95% CI 0.67 - 3.91], p=0.28
Maltese: Rata ta' rikorrenza (3 snin) Rata ta' rikorrenza (5 snin) Rata ta' rikorrenza (7 snin) HR: 1.62 [95% CI 0.67 - 3.91], p=0.28
English: Total number of patients with recurrence (5.4 years) Low activity RAI (1.1 GBq) High activity RAI (3.7 GBq)
Maltese: Total ta' numru ta' pazjenti b'rikorrenzi (5.4 snin) Attività baxxa RAI (1.1 GBq)
English: Thyrogen does not contain preservatives.
Maltese: Thyrogen ma fihx preservattivi.
English: I, Thyrogen + 100 mCi
Maltese: Thyrogen + 30 mCi 131-I,
English: The median follow-up was 5.4 years (0.5 to 9.2 years).
Maltese: Il-medjan ta' segwitu kien ta' 5.4 snin (0.5 sa 9.2 snin).
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa sa persuna waħda minn kull 10):
English: For the HiLo study, 434 (99%) of the original 438 patients were followed up for disease recurrence.
Maltese: Għall-istudju HiLo, 434 (99%) mill-oriġinali 438 pazjent ġew segwiti għar-rikorrenza tal-marda.
English: Formal interaction studies between Thyrogen and other medicinal products have not been performed.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni bejn Thyrogen u prodotti mediċinali oħra.
English: Recurrence rate (3 years)
Maltese: Rata ta' rikorrenza (3 snin)
English: • flu symptoms
Maltese: • sintomi tal-influwenza
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.
Maltese: Bl-użu ta' dan il-kriterju ta' Tg, 18/21 pazjent (86%) u 23/24pazjent (96%) kellhom asportazzjoni tal-fdal tat-tirojde li rnexxiet fil-grupp ta' waqfien ta' THST u fil-grupp ta' trattament ta' Thyrogen rispettivament.
English: • low TSH
Maltese: • TSH baxx
English: Gastrointestinal disorders nausea vomiting diarrhoea
Maltese: Disturbi gastrointestinali dardir rimettar dijarea
English: Thyrogen Thyroid Hormone Withdrawal (THW)
Maltese: L-irtirar tal-Ormon tat-Tirojde (THWThyroid Hormone Withdrawal )
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħzen fi friġġ (2°C - 8°C).
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.
Maltese: III li kien jinvolvi 164 pazjent, ir-rata ta' intraċċar b'tessuti ta' oriġini tat-tirojde wara test ta' thyroglobulin ta' Thyrogen kellha medda ta' 73-87%, filwaqt, li permezz talużu ta' thyroglobulin fuq it-TSHT kienet ta' bejn 42-62% għall-istess valuri cut-off u standards ta' riferenza komparabbli.
English: Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
Maltese: Thyrogen hu indikat għall-istimulazzjoni qabel it-terapija flimkien ma' medda ta' 30 mCi (1.1 GBq) sa 100 mCi (3.7 GBq) jodju radjuattiv għal tneħħija ta' fdal ta' tessut tat-tirojde f'pazjenti li kellhom intervent ta' tneħħija totali jew kważi totali tat-tirojde minħabba kanċer differenzjat sew tat-tirojde u li ma jkollhomx evidenza ta' kanċer tat-tirojde metastatiku distanti (ara sezzjoni 4.4).
English: Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa.
Maltese: Kull kunjett ta' Thyrogen fih valur nominali ta' 0.9 mg thyrotropin alfa.
English: • prickling or tingling sensation (paraesthesia),
Maltese: • sensazzjoni ta' tingiż u tnemnim (parestiżja)
English: neoplasm swelling, metastatic pain
Maltese: nefħa tanneoplażma, uġigħ metastatiku
English: • influenza
Maltese: • influwenza
English: Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Maltese: Thyrotropin alfa (ormon rikombinanti li jistimula t-tirojde umana) hi glikoproteina eterodimerika magħmula permezz tat-teknoloġija tad-DNA rikombinanti.
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.
Maltese: Globalment, 48/51 pazjent (94%) ma kellhom l-ebda evidenza ta' rikorrenza ta' kanċer, pazjent wieħed kellu rikorrenza possibbli ta' kanċer (għalkemm ma kienx ċar jekk dan il-pazjent kellux rikorrenza vera jew tumur persistenti mill-marda reġjonali nnutata fil-bidu tal-istudju oriġinali), u 2 pazjenti ma setgħux jiġu evalwati.
English: Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Maltese: Kull kunjett fih 0.9 mg/ml ta' thyrotropin alfa meta jiġi rikostitwit b'1.2 ml ta' ilma għall injezzjonijiet.
English: • excessive sweating
Maltese: • għaraq eccessiv
English: Cardiac disorders palpitations
Maltese: Disturbi fil-qalb palpitazzjonijiet
English: Thyrogen contains sodium, see section 2.
Maltese: Thyrogen fih is-sodium, ara sezzjoni 2
English: The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
Maltese: L-effetti mhux mixtieqa l-aktar komuni rrappurtati huma d-dardir u l-uġigħ ta' ras, li jseħħu f'madwar 11% u 6% tal-pazjenti, rispettivament.
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.
Maltese: Ibbażat fuq 684 pazjent li setgħu jiġu evalwati, ir-rata globali ta' tneħħija li rnexxiet evalwata permezz ta' ultrasounds tal-għonq u livelli tat-Tg stimulati kienet ta' 92%, mingħajr l-ebda differenza statistikament sinifikanti fost l-erba' gruppi.
English: Use aseptic technique
Maltese: Użu ta' teknika asettika
English: 5 PHARMACOLOGICAL PROPERTIES
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: <PC: SN:
Maltese: SN:
English: • inability to taste (ageusia)
Maltese: • l-inkapaċità li ttiegħem (agewsja)
English: How to store Thyrogen
Maltese: Mediċini oħra u Thyrogen
English: Recurrence rate (5 years) Recurrence rate (7 years)
Maltese: Rata ta' rikorrenza (5 snin)
English: Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen).
Maltese: Scanning dijanjostiku għandu jsir fi żmien 48 sa 72 siegħa wara l-għoti ta' jodju radjuattiv (72 sa 96 siegħa wara l-aħħar injezzjoni ta' Thyrogen).
English: • hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.
Maltese: • sensittività eccessiva (reazzjonijiet allerġici), dawn ir-reazzjonijiet jinkludu ħorriqija (urtikarja), ħakk, fwawar, diffikultà biex tieħu n-nifs u raxx.
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).
Maltese: (> 18-il sena) b'karċinoma papillari jew follikulari tat-tirojde differenzjata u ddijanjostikata riċentement, li tinkludi varjant papillari-follikulari, ikkaratterizzat, prinċipalment (54 minn 60), bħala
English: As assessed by radioiodine imaging and stimulated Tg levels (n = 421), ablation success rates were approximately 86% in all four treatment groups.
Maltese: Kif evalwat minn immaġni bil-jodju radjuattiv u livelli tat-Tg stimulati (n = 421), ir-rati ta' suċċess tat-tneħħija kienu madwar 86% fl-erba' gruppi.
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).
Maltese: F'wieħed minn dawn l-istudji, żewġ korsijiet ta' doża ġew eżaminati: 0.9 mg mogħtija ġol-muskolu kull 24 siegħa għal żewġ dożi (0.9 mg x 2) u 0.9 mg ġol-muskolu kull 72 siegħa għal tliet dożi (0.9 mg x 3).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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).
Maltese: It-twaħħil ta' thyrotropin alfa ma' riċetturi ta' TSH fuq iċ-ċelluli epiteljali tat-tirojde jistimula l-assorbiment tal-jodju u l-organifikazzjoni, u s-sintesi u l-ħruġ ta' thyroglobulin, triiodothyronine (T3) u thyroxin (T4).
English: • impaired sense of taste (dysgeusia)
Maltese: • tnaqqis fis-sens tat-togħma (disgewsja)
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.
Maltese: Fi provi kliniċi li kienu jinvolvu 481 pazjent, l-ebda pazjent ma żviluppa antikorpi għal thyrotropin alfa wara użu wieħed jew użu ripetut limitat (27 pazjent) tal-prodott.
English: Thyrogen-stimulated thyroglobulin testing was also performed.
Maltese: Saru wkoll testijiet għal thyroglobulin stimulat b'Thyrogen.
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.
Maltese: thyroglobulin stimulat minn Thyrogen kienu jikkorrispondu ma' livelli ta' thyroglobulin wara lwaqfien tal-ormon ta' 10 ng/ml, 5 ng/ml u 2 ng/ml rispettivament.
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.
Maltese: istudju ESTIMABL1 għażel b'mod każwali 752 pazjent b-kanċer tat-tirojde ta' riskju baxx (stadji tattumur pT1 < 1 ċm u N1 jew Nx, pT1 >1-2 ċm u kwalunkwe stadju N, jew pT2 N0, il-pazjenti kollha
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.
Maltese: Is-soluzzjoni rikostitwita tista' tiġi maħżuna sa 24 siegħa fi friġġ (2°C - 8°C) protetta mid-dawl, waqt li tiġi evitata l-kontaminazzjoni mill-mikrobi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva
English: Thyrogen 0.9 mg powder for solution for injection Thyrotropin alfa
Maltese: U MNEJN GĦANDU JINGĦATA Thyrogen 0.9 mg trab għal soluzzjoni għall-injezzjoni thyrotropin alfa
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.
Maltese: L-effetti mhux mixtieqa msemmija fit-tabella, jikkombinaw l-effetti mhux mixtieqa f'sitt provi kliniċi prospettivi (N=481) u effetti mhux mixtieqa li ġew irrappurtati lil Genzyme wara li ngħatat il-liċenzja ta' Thyrogen.
English: One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Maltese: Pazjent addizzjonali rreġistrat fi prova klinika kellu sintomi wara li rċieva Thyrogen minn ġol-vina.
English: Intramuscular use.
Maltese: Disturbi respiratorji,
English: Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues.
Maltese: Ormoni u Analogi tal-Lobu Pitwitarju u tal-Ipotalamu, Ormoni u
English: THYROGEN 0.9 mg powder for solution for injection.
Maltese: Thyrogen 0.9 mg trab għal soluzzjoni għall-injezzjoni.
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.
Maltese: Riżultati minn provi kkontrollati jindikaw li m'hemmx differenza fis-sigurtà u l-effikaċja ta' Thyrogen bejn pazjenti adulti li għandhom inqas minn 65 sena u dawk ta' aktar minn 65 sena, meta Thyrogen jintuża għal skopijiet dijanjostiċi.
English: • stroke
Maltese: • sturdament
English: After reconstitution with water for injection, 1.0 ml solution (0.9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock.
Maltese: Wara r-rikonstituzzjoni bl-ilma għall-injezzjoni, 1.0 ml soluzzjoni (0.9 mg ta' thyrotropin alfa)
English: Thyrogen 0.9 mg powder for solution for injection
Maltese: Thyrogen 0.9 mg trab għal soluzzjoni għall-injezzjoni
English: A follow-up study was conducted on patients who previously completed the initial study, and data is available for 51 patients.
Maltese: Sar studju follow-up fuq pazjenti li kienu lestew l-istudju inizjali, u data fuq 51 pazjent hi disponibbli.
English: Table 3.
Maltese: 3 snin.
English: After injection, the mean peak (Cmax) level obtained was 116 ± 38 mU/l and occurred approximately 13 ± 8 hours after administration.
Maltese: Wara l-injezzjoni, l-ogħla livell medju (Cmax) li ntlaħaq kien ta' 116 ± 38 mU/l u seħħ bejn wieħed u ieħor 13 ± 8 sigħat wara li ngħata.
English: It is unknown whether thyrotropin alfa /metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk thyrotropin alfa/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
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
Maltese: mnejn jingħata għeja, asthenia mard simili għall influwenza, deni, tertir, tħoss is sħana skonfort, uġigħ, ħakk, raxx u urtikarja fis-sit talinjezzjoni
English: Pre-therapeutic stimulation
Maltese: TAL-PRODOTT MEDIĊINALI
English: This equals 0.9 mg thyrotropin alfa to be injected.
Maltese: Dan hu ekwivalenti għal 0.9 mg thyrotropin alfa li għandu jkun injettat.
English: Musculoskeletal and connective tissue disorder neck pain, back pain arthralgia, myalgia
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi uġigħ fl-għonq, uġigħ fid-dahar artralġja, mijalġja
English: The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Maltese: Il-farmakokinetika ta' Thyrogen kienet studjata f'pazjenti li kellhom kanċer tat-tirojde li kien differenzjat sewwa wara injezzjoni ġol-muskoli waħda ta' 0.9 mg.
English: Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
Maltese: Edema larinġeali, problemi respiratorji li jeħtieġu trakeotomija, u wġigħ fis-sit tal-metastasi ġew irrappurtati wkoll wara li ngħata Thyrogen.
English: In a comparator study involving 60 evaluable patients, the rates of successful ablation of thyroid remnants with 100 mCi/3.7 GBq (± 10%) radioiodine in post-thyroidectomy patients with thyroid cancer, were comparable for patients treated after thyroid hormone withdrawal versus patients treated after Thyrogen administration.
Maltese: Fi studju komparattiv li kien jinvolvi 60 pazjent li jistgħu jiġu evalwati, ir-rati ta' asportazzjoni li rnexxew ta' fdalijiet tat-tirojde b'100 mCi/3.7 GBq (± 10%) ta' jodju radjuattiv f'pazjenti li kellhom tirojdektomija b'kanċer tat-tirojde, kienu paragunabbli għal pazjenti ttrattati wara l-waqfien tal-ormon tat-tirojde meta mqabbla ma pazjenti ttrattati wara l-għoti ta' Thyrogen.
English: The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Maltese: Il-kors tad-doża rrakkomandata ta' Thyrogen hi żewġ injezzjonijiet ġol-muskoli ta' 0.9 mg thyrotropin alfa mogħtija f'intervall ta' 24 siegħa.
English: Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.
Maltese: Informazzjoni dwar espożizzjoni ogħla mid-doża rrakkomandata hi limitata għal studji kliniċi u programm ta' trattament speċjali.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni talprodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
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.
Maltese: Il-livelli ta' thyroglobulin stimulati minn Thyrogen kienu ogħla minn 2 ng/ml fil-35 pazjent kollha, filwaqt, li thyroglobulin fuq it-THST kien ogħla minn 2 ng/ml f'79 % ta' dawn il-pazjenti.
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.
Maltese: It-28 pazjent (100%) ilkoll ittrattati wara l-waqfien ta' THST u t-32 pazjent (100%) ilkoll ittrattatiwara l-għoti ta' Thyrogen, kellhom jew l-ebda teħid viżibbli ta' jodju radjoattiv fit-thyroid bed jew, jekk viżibbli, it-teħid fit-thyroid bed kien <0.1% tal-attività mogħtija ta' jodju radjoattiv.
English: It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Maltese: Hu rrakkomandat li trattament minn qabel b'kortikosterojdi tiġi kkunsidrata f'pazjenti fejn it-tkabbir lokali tat-tumur jista' jikkomprometti strutturi anatomiċi vitali.
English: After reconstitution with 1.2 ml water for injection, 1.0 ml of solution (equal to 0.9 mg Thyrogen) is withdrawn and administered to the patient.
Maltese: Wara r-rikostituzzjoni b'1.2 ml ta' ilma għall-injezzjonijiet, 1.0 ml ta' soluzzjoni (ugwali għal 0.9 mg Thyrogen) tinġibed u tingħata lill-pazjent.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: The pH of the Thyrogen solution is approximately 7.0.
Maltese: Il-pH tas-soluzzjoni ta' Thyrogen hu ta' madwar 7.0.
English: Sanofi S.p.A. Tel: +800536389
Maltese: Tel: 800536389
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.
Maltese: Fil-programm ta' trattament speċjali, pazjent ta' 77 sena b'kanċer metastatiku tat-tirojde li ma kellux tirojdektomija, irċieva 4 dożi ta' Thyrogen 0.9 mg fuq sitt ijiem,
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.
Maltese: L-għan prinċipali tal-istudju follow-up kien li jikkonferma l-istat ta' tneħħija ta' fdal ta' tirojde bl-użu ta' immaġini tal-għonq statiku permezz ta' jodju radjuattiv stimulat b'Thyrogen wara follow-up medjan ta' 3.7 snin (firxa minn 3.4 sa 4.4 snin) wara t-tneħħija b'jodju radjuattiv.
English: Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Maltese: Thyrogen hu indikat għal użu ma' testijiet tat-thyroglobulin (Tg) fis-serum bl-immaġini ta' jodju radjuattiv jew mingħajru biex ikun stabbilit jekk hemmx xi fdal tat-tirojde u kanċer tat-tirojde li hu differenzjat sewwa fil-pazjenti li kellhom tirojdektomija u li qegħdin fuq terapija ta' trażżin tal ormoni (THST).
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.
Maltese: Dan il-pazjent irċieva 0.3 mg ta' Thyrogen bħala doża bolus waħda ġol-vina (IV) u, 15-il minuta wara kellu dardir qawwi, rimettar, dijaforesi, pressjoni baxxa u takikardja.
English: This may lead to acute symptoms, which depend on the anatomical location of the tissue.
Maltese: Dan jista' jwassal għal sintomi akuti, li jiddependu fuq is-sit anatomiku tat-tessut.
English: When used as an alternative to thyroid hormone withdrawal, the combination of the whole body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
Maltese: Meta jingħata bħala alternattiva wara waqfien tal-ormoni tat-tirojde, il-kombinazzjoni ta' xintigrafija tal-ġisem kollu (WBS) u testijiet tat-Tg flimkien, wara li jkun ingħata Thyrogen, jiżguraw l-ogħla sensittività biex jiġi stabbilit jekk hemmx xi frak tat-tirojde jew kanċer.
English: For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Maltese: Għal follow-up dijanjostiku tat-testijiet ta' thyroglobulin (Tg) fis-serum, il-kampjun tas-serum għandu jittieħed 72 siegħa wara l-injezzjoni finali ta' 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.
Maltese: Evalwazzjoni bir-reqqa tar-relazzjonijiet bejn il-benefiċċju u r-riskju għandha tiġi evalwata f'pazjenti li qegħdin f'riskju għoli ta' mard tal-qalb li jingħataw Thyrogen (eż. mard valvulari tal-qalb , kardjomijopatija, mard fl-arterja koronarja, u jekk għandhom jew kellhomx takiarritmija fil-passat, li tinkludi fibrillazzjoni atrijali) u ma kellhomx tirojdektomija.
English: ATC code for thyrotropin alfa: H01AB01
Maltese: Kodiċi ATC għal thyrotropin alfa:
English: When the powder is dissolved the total volume in the vial is 1.2 ml.
Maltese: Meta t-trab jinħall, il volum totali fil-kunjett ikun ta' 1.2 ml.
English: In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
Maltese: (T3) u thyroxine(T4) meta ngħataw fl-istess ħin.
English: TSH decreased
Maltese: Tnaqqis fit-TSH
English: Intramuscular injection only.
Maltese: Injezzjoni ġol-muskoli biss.
English: - The other ingredients are:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: If you are given more Thyrogen than you should receive Patients who accidentally received too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting and hot flashes.
Maltese: Pazjenti li aċċidentalment jirċievu aktar Thyrogen milli suppost irrappurtaw li kellhom dardir, debbulizza, sturdament, uġigħ ta' ras, rimettar u fwawar.