FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Slovenian: Menijo, da je to povezano s zvišanjem ravni ščitnico stimulirajočega hormona (TSH) skozi daljši čas.
English: One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging.
Slovenian: Eden od učinkov je stimuliranje ostankov ščitničnega tkiva k privzemu joda, ki je pomemben za slikanje z radioaktivnim jodom.
English: Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen).
Slovenian: Diagnostični pregled je treba opraviti 48 do 72 ur po dajanju radioaktivnega joda (72 do 96 ur po zadnji injekciji zdravila Thyrogen).
English: Use of Thyrogen with Tg testing in follow up of post-thyroidectomy well differentiated thyroid cancer patients should be in accordance with official guidelines.
Slovenian: Uporaba zdravila Thyrogen z testiranjem Tg za spremljanje posttiroidektomijskih bolnikov z dobro diferenciranim rakom ščitnice mora biti v skladu z uradnimi smernicami.
English: There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth.
Slovenian: Obstaja teoretična možnost, da zdravilo Thyrogen, tako kot odstranitev tiroidnega hormona, povzroči stimulirano rast tumorjev.
English: Each vial of Thyrogen is for single use only.
Slovenian: Vsaka viala zdravila Thyrogen je samo za enkratno uporabo.
English: Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.
Slovenian: Vaš zdravnik ali medicinska sestra bo injiciral/-a 1,0 ml raztopine zdravila Thyrogen.
English: What Thyrogen is and what it is used for
Slovenian: Kaj je zdravilo Thyrogen in za kaj ga uporabljamo
English: • Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost za ščitnico stimulirajoči hormon govejega ali humanega izvora ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • if you have kidney disease that requires dialysis and he will decide how much Thyrogen to give to you as you may have more chance of experiencing headache and nausea.
Slovenian: • če imate bolezen ledvic, zaradi katere je potrebna dializa, da se odloči o količini zdravila Thyrogen, ki jo bo odmeril, saj imate večjo možnost, da se pojavita glavobol ali slabost,
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.
Slovenian: Podatki o kinetiki radioaktivnega joda kažejo, da je pri zmanjšanem ledvičnem delovanju očistek radioaktivnega joda v evtirotičnem stanju približno 50 % večji kot v hipotirotičnem stanju, kar vodi k zmanjšanemu zadrževanju radioaktivnega joda v telesu v času scintigrafije.
English: One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Slovenian: Še pri enem dodatnem bolniku, ki je bil vključen v klinično preskušanje, so se simptomi pojavili po prejemu zdravila Thyrogen intravensko.
English: Pack sizes: one or two vials of Thyrogen per carton.
Slovenian: Velikost pakiranja: ena ali dve viali zdravila Thyrogen na škatlico.
English: Other medicines and Thyrogen Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging.
Slovenian: Ta dejavnik je potrebno upoštevati pri določanju aktivnosti radioaktivnega joda za uporabo pri scintigrafiji z radioaktivnim jodom.
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).
Slovenian: Raztopina zdravila Thyrogen ostane kemijsko stabilna do 24 ur, če jo shranjujete v hladilniku (med 2 °C in 8 °C).
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.
Slovenian: Če vaša žleza ščitnica ni bila povsem odstranjena in imate hkrati srčno obolenje, vam bo zdravnik svetoval ali naj prejemate zdravilo Thyrogen.
English: What you need to know before you use Thyrogen
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Thyrogen
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.
Slovenian: Glavni cilj spremljevalne študije je bil potrditi stanje ablacije tiroidnih ostankov z uporabo statične scintigrafije vratu z radioaktivnim jodom, stimulirane z zdravilom Thyrogen, po mediani spremljanja 3,7 let (razpon 3,4 do 4,4 leta) po ablaciji z uporabo radioaktivnega joda.
English: OUTER CARTON - PACK OF 1 VIAL OUTER CARTON - PACK OF 2 VIALS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 VIALA ZUNANJA OVOJNINA - 2 VIALI
English: This may lead to increased risk of headache and nausea.
Slovenian: To lahko povzroči zvečano tveganje glavobola in navzee.
English: • influenza
Slovenian: • gripa
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.
Slovenian: odmerka 2,7 mg pojavila navzea in pri enem od teh bolnikov so se poleg navzee pojavili še šibkost, omotica in glavobol.
English: These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms.
Slovenian: Med te pojave spadajo urtikarija, izpuščaj, pruritus, vročinski oblivi ter respiratorni znaki in simptomi.
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.
Slovenian: Diagnostično scintigrafijo izvršimo 48 ali 72 ur po prejetju radioaktivnega joda, medtem ko lahko scintigrafijo po ablaciji odložimo za nekaj dni, da se zmanjša izvorna aktivnost.
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.
Slovenian: Standardni pristop za zvišanje ravni TSH je prenehanje z zdravljenjem s hormonsko supresivno terapijo (THST) pri bolnikih, pri katerih ponavadi povzroči znake ali simptome hipotiroidizma.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijo, kar v bistvu pomeni ‘brez natrija'.
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.
Slovenian: V dveh velikih prospektivnih, randomiziranih študijah - študiji HiLo (Mallick) in študiji ESTIMABL (Schlumberger) - so primerjali metode ablacije tiroidnih ostankov pri bolnikih z diferenciranim rakom ščitnice, katerim so odstranili ščitnico.
English: The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Slovenian: Farmakokinetične lastnosti zdravila Thyrogen so bile raziskane pri bolnikih z dobro diferenciranim rakom ščitnice po enkratnem 0,9 mg intramuskularnem injiciranju.
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.
Slovenian: Pri kliničnih preskušanjih, ki so vključevali 481 bolnikov, ni nobeden izmed bolnikov, niti po enkratni niti po večkratni omejeni (27 bolnikov) uporabi zdravila razvil protiteles proti tirotropinu alfa.
English: Dispose of any unused solution immediately.
Slovenian: Neuporabljeno raztopino nemudoma zavrzite.
English: In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Slovenian: Pri bolnikih z dobro diferenciranim rakom ščitnice se ščitnica skoraj popolnoma ali popolnoma odstrani.
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).
Slovenian: Vezava tirotropina alfa na receptorje TSH epitelnih celic ščitnice stimulira privzemanje in organifikacijo joda ter sintezo in sproščanje tiroglobulina, trijodotironina (T3) in tiroksina (T4).
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.
Slovenian: Uspešnost ablacije tiroidnih ostankov se je ocenjevala tudi s kriterijem z zdravilom Thyrogen stimulirane ravni Tg v serumu < 2 ng/ml osem mesecev po ablaciji, a le pri bolnikih, negativnih na interfirajoča anti-Tg protitelesa.
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.
Slovenian: V študiji ESTIMABL je bilo v 24 raziskovalnih centrih naključno razporejenih 752 bolnikov z rakom ščitnice z manjšim tveganjem (stadiji tumorja pT1 < 1 cm in N1 ali Nx, pT1 >1-2 cm in kateri koli stadij N ali pT2 N0, vsi bolniki M0).
English: Effect on tumour growth
Slovenian: Vpliv na rast tumorjev
English: • flu symptoms
Slovenian: • gripi podobni simptomi
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.
Slovenian: Pri nizko ogroženih bolnikih z dobro diferenciranim karcinomom ščitnice in nezaznavnimi ravnmi Tg v serumu pri THST ter brez rh (rekombinantni, humani) TSH-stimuliranega zvišanja ravni Tg lahko nadaljujemo z določanjem rh TSH- stimulirane ravni Tg.
English: Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Thyrogen se posvetujte z zdravnikom ali farmacevtom
English: Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki so lahko po dajanju zdravila Thyrogen omotični ali imajo glavobole, kar lahko vpliva na sposobnost upravljanja vozil in strojev.
English: It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity.
Slovenian: Ni znano, ali zdravilo Thyrogen, ki ga dobi nosečnica, lahko škoduje plodu in ali lahko vpliva na zmožnost razmnoževanja.
English: The efficacy and safety of Thyrogen for use with radioiodine imaging together with serum thyroglobulin testing for the diagnosis of thyroid remnants and cancer was demonstrated in two studies.
Slovenian: Učinkovitost in varnost zdravila Thyrogen za uporabo scintigrafije z radioaktivnim jodom skupaj s testiranjem tiroglobulina v serumu za diagnozo tiroidnih ostankov in raka sta bili predstavljeni v dveh študijah.
English: False negative results may occur with Thyrogen.
Slovenian: Z zdravilom Thyrogen lahko dobimo tudi lažno negativne rezultate.
English: Both dose regimens were effective and not statistically different from thyroid hormone withdrawal in stimulating radioiodine uptake for diagnostic imaging.
Slovenian: Obe shemi odmerjanja sta bili učinkoviti in statistično nista bili različni od odstranitve tiroidnih hormonov, kar se tiče stimulacije privzema radioaktivnega joda za diagnostično scintigrafijo.
English: Your treatment should be supervised by a doctor who has expertise in thyroid cancer.
Slovenian: Vaše zdravljenje naj nadzoruje zdravnik z izkušnjami s področja raka ščitnice.
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.
Slovenian: Vseh 28 bolnikov (100 %), zdravljenih po prekinitvi THST in vseh 32 bolnikov (100 %), zdravljenih po dajanju zdravila Thyrogen, ni kazalo vidnega privzema radioaktivnega joda v ležišče ščitnice ali je kazalo < 0,1 % privzema uvedene aktivnosti radioaktivnega joda.
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.
Slovenian: Informacije pridobljene v obdobju trženja in objavljene informacije kažejo, da je izločanje zdravila Thyrogen pomembno upočasnjeno pri bolnikih s končno stopnjo ledvične bolezni (ESRD - end stage renal disease), ki so odvisni od dialize, kar povzroči podaljšano zvečanje ravni ščitnico stimulirajočega hormona (TSH) še nekaj dni po zdravljenju.
English: To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Slovenian: Da bi bilo vsakič na voljo dovolj prostornine za natančen odmerek, vsebuje vsaka viala zdravila Thyrogen 0,2 ml presežka.
English: A follow-up study was conducted on patients who previously completed the initial study, and data is available for 51 patients.
Slovenian: Spremljevalna študija se je izvajala z bolniki, ki so pred tem zaključili začetno študijo.
English: Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes.
Slovenian: Zdravilo Thyrogen je humani ščitnico stimulirajoči hormon (TSH), ki se izdeluje v biotehnološkem postopku.
English: I, thyroid hormone withdrawal + 30 mCi
Slovenian: , odstranitev tiroidnega hormona + 30 mCi
English: Thyrogen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Slovenian: Zdravila Thyrogen vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni “brez natrija”.
English: There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.
Slovenian: Ni znanega medsebojnega delovanja drugih zdravil z zdravilom Thyrogen in ščitnico stimulirajočimi hormoni, ki jih morda jemljete.
English: The HiLo study randomised 438 patients (tumour stages T1-T3, Nx, N0 and N1, M0) at 29 centres.
Slovenian: V študiji HiLo je bilo v 29 raziskovalnih centrih naključno razporejenih 438 bolnikov (s stadiji tumorja T1-T3, Nx, N0 in N1, M0).
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.
Slovenian: Rekonstituirano raztopino lahko shranjujete do 24 ur v hladilniku (2 °C - 8 °C), zaščiteno pred svetlobo.
English: Musculoskeletal and connective tissue disorder neck pain, back pain arthralgia, myalgia
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v vratu, bolečine v hrbtu artralgija, mialgija
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.
Slovenian: Natančneje, pri študiji v tretji fazi s 164 bolniki je bil odstotek odkritja tkiva ščitnice po testiranju tiroglobulina z zdravilom Thyrogen med 73 - 87 %, medtem ko je ta vrednost pri istih mejnih vrednostih in primerljivih referenčnih standardih pri testiranju tiroglobulina s THST znašala med
English: In these studies the use of thyroglobulin testing on Thyrogen was found to be more sensitive than thyroglobulin testing on TSHT.
Slovenian: V teh študijah so se testiranja tiroglobulina z zdravilom Thyrogen izkazali za občutljivejše od tistih s THST.
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.
Slovenian: V primerjalni študiji s 60 bolniki je bila stopnja uspešnih ablacij tiroidnih ostankov s 100 mCi/3,7 GBq (± 10 %) radioaktivnega joda pri bolnikih po tiroidektomiji z rakom ščitnice primerljiva med bolniki, zdravljenimi po prekinitvi tiroidnega hormona, in bolniki, zdravljenimi z zdravilom Thyrogen.
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
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost, astenija gripi podobna bolezen, pireksija, mrzlica, občutek vročine neugodje, bolečina, pruritus, izpuščaj in urtikarija na mestu intramuskularnega injiciranja
English: Due to elevation of TSH levels after Thyrogen administration patients with metastatic thyroid cancer particularly in confined spaces such as the brain, spinal cord and orbit or disease infiltrating the neck, may experience local oedema or focal haemorrhage at the site of these metastases resulting in increased tumour size.
Slovenian: Zaradi povišanja ravni TSH po dajanju zdravila Thyrogen bolniki z metastatskim rakom ščitnice, še posebno v omejenih prostorih, kot so možgani, hrbtenjača in orbita ali infiltracija vratu, lahko dobijo lokalne edeme ali fokalne krvavitve na mestu teh metastaz, kar poveča velikost tumorja.
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.
Slovenian: Z uporabo tega kriterija Tg je kazalo znake uspešne ablacije tiroidnih ostankov 18/21 bolnikov (86 %) v skupini s prekinitvijo THST in 23/24 bolnikov (96 %) v skupini zdravljenih z zdravilom Thyrogen.
English: Therefore, both TgAb and Tg assays are needed.
Slovenian: Zato je potrebno določanje vrednosti tako TgAb kot Tg.
English: Thyrogen should not be given to breast-feeding women.
Slovenian: Zdravila Thyrogen se ne sme dajati ženskam, ki dojijo.
English: Very rare cases of hyperthyroidism (increased activity of the thyroid gland) or atrial fibrillation have been reported when Thyrogen was administered to patients who had not undergone total or partial removal of the thyroid gland.
Slovenian: Poročali so o zelo redkih primerih hipertiroidizma (povečano delovanje žleze ščitnice) ali atrijske fibrilacije, ko je bilo zdravilo Thyrogen dano bolnikom, katerim niso v celoti ali delno odstranili ščitnice.
English: • injection site reactions (including: redness, discomfort, itching, local pain or stinging, and an itchy rash)
Slovenian: • reakcije na mestu injiciranja (vključujejo: pordelost, neugodje, srbenje, lokalno bolečino ali zbadanje in srbeči izpuščaj)
English: Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 ± 1 months after treatment.
Slovenian: Uspešnost ablacije ostankov se je ocenjevala s scintigrafijo z radioaktivnim jodom in s testiranjem tiroglobulina v serumu 8 ± 1 mesecev po zdravljenju.
English: Thyrogen powder must be dissolved in water for injection.
Slovenian: Prašek zdravila Thyrogen mora biti raztopljen v vodi za injekcije.
English: A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
Slovenian: V primeru prevelikega odmerjanja se priporoča ponovna vzpostavitev ravnovesja tekočin v telesu in eventualno uporaba antiemetika.
English: All patients considered ablated in the initial study were confirmed to be ablated in the follow-up study.
Slovenian: Pri vseh bolnikih, pri katerih je bila ablacija ocenjena kot uspešna v prvotni študiji, je bil uspeh ablacije potrjen tudi v spremljevalni študiji.
English: Thyrogen is known to cause a transient but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ.
Slovenian: Znano je, da povzroča zdravilo Thyrogen prehodno, a statistično značilno povečanje koncentracije tiroidnega hormona v serumu, če se daje bolnikom, ki imajo in situ še vedno veliko količino tiroidnega tkiva.
English: What Thyrogen looks like and contents of the pack
Slovenian: Izgled zdravila Thyrogen in vsebina pakiranja
English: Mannitol
Slovenian: • manitol
English: Package size: one or two vials per carton.
Slovenian: Velikost pakiranja: Škatla z eno ali dvema vialama.
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.
Slovenian: Po rekonstituciji z 1,2 ml vode za injekcije se 1,0 ml raztopine (enakovredno 0,9 mg zdravila Thyrogen) odvzame in injicira bolniku.
English: For optimal diagnosis of thyroid remnants or cancer via either radioiodine imaging or thyroglobulin testing and for radioiodine therapy of thyroid remnants, a high serum level of TSH is needed to stimulate either radioiodine uptake and/or thyroglobulin release.
Slovenian: Za optimalno diagnozo tiroidnih ostankov ali raka s scintigrafijo z radioaktivnim jodom ali s tiroglobulinskim preskušanjem in zdravljenjem tiroidnih ostankov z radioaktivnim jodom potrebujemo visoko raven TSH v serumu, da stimulira privzem radioaktivnega joda in/ali sproščanje tiroglobulina.
English: Metastatic disease was confirmed by a post-treatment scan or by lymph node biopsy in 35 patients.
Slovenian: S slikanjem po zdravljenju ali z biopsijo limfnih vozlov so metastatsko bolezen potrdili pri 35 bolnikih.
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).
Slovenian: Zdravilo Thyrogen je, v kombinaciji z od 30 mCi (1,1 GBq) do 100 mCi (3,7 GBq) radioaktivnega joda, indicirano za predterapevtsko stimulacijo za ablacijo ostankov tiroidnega tkiva pri bolnikih s skoraj popolno ali popolno tiroidektomijo dobro diferenciranega raka ščitnice, pri katerih ni znakov oddaljenega metastatskega raka ščitnice (glejte poglavje 4.4).
English: Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Slovenian: Tirotropin alfa (rekombinantni humani ščitnico stimulirajoči hormon) je heterodimerni glikoprotein, izdelan s tehnologijo rekombinantne DNA.