natgillin/translations-raw huggingface dataset:
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.
Na temelju 684 bolesnika dostupna za procjenu, ukupna stopa uspješnosti ablacije ocijenjena ultrazvučnim pregledima vrata i razinama Tg nakon stimulacije iznosila je 92%, a između te četiri skupine nije bilo statistički značajne razlike.
When the powder is dissolved the total volume in the vial is 1.2 ml.
Kad se prašak otopi, ukupan volumen u bočici iznosi 1,2 ml.
The HiLo study randomised 438 patients (tumour stages T1-T3, Nx, N0 and N1, M0) at 29 centres.
U ispitivanju HiLo randomizirano je 438 bolesnika (stadiji tumora T1-T3, Nx, N0 i N1, M0) u 29 centara.
A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
Predloženo liječenje u slučaju predoziranja sastoji se u ponovnom uspostavljanju ravnoteže tekućine, a može se razmotriti i primjena antiemetika.
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.
Dijagnostičku scintigrafiju treba provesti 48 do 72 sata nakon primjene radioaktivnog joda, dok se scintigrafija nakon ablacije može odgoditi za nekoliko dana dok se ne smanji pozadinska aktivnost.
The tables below provide long term follow up information for the ESTIMABL1 and HiLo studies
Niže navedene tablice sadrže podatke dugoročnog praćenja iz ESTIMABL1 i HiLo ispitivanja.
Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Tireotropin alfa (rekombinantni humani hormon koji stimulira štitnjaču) je heterodimerni glikoprotein proizveden tehnologijom rekombinantne DNK.
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.
Rekonstituirana se otopina može čuvati do 24 sata u hladnjaku (2°C - 8°C), zaštićena od svjetlosti i pritom izbjegavajući mikrobiološku kontaminaciju.
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.
Treba pažljivo procijeniti odnos rizika i koristi primjene lijeka Thyrogen u visokorizičnih starijih bolesnika koji boluju od srčane bolesti (npr. bolesti srčanih zalistaka, kardiomiopatije, bolesti koronarnih arterija te ranije ili trenutno postojeće tahiaritmije uključujući fibrilaciju atrija), a nisu bili podvrgnuti tireoidektomiji.
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.
Komplementarne DNK (cDNA) kodiraju za alfa podjedinicu od 92 aminokiselinska ostatka s dva N-vezana glikozilacijska mjesta i beta podjedinicu od 118 aminokiselinskih ostataka s jednim N-vezanim glikozilacijskim mjestom.
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).
U ispitivanju su sudjelovali odrasli bolesnici (> 18 godina) s novodijagnosticiranim diferenciranim papilarnim ili folikularnim karcinomom štitnjače, uključujući i papilarno-folikularni tip, koji su uglavnom (54 od 60) klasificirani kao T1-T2, N0-N1, M0 (TNM klasifikacija).
To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Kako bi se osigurao dovoljan volumen za precizno doziranje, svaka bočica lijeka Thyrogen sadrži suvišak od 0,2 ml.
High activity dose RAI (3.7 GBq)
Doza radioaktivnog joda visoke aktivnosti (3,7 GBq)
One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging.
Jedan od njegovih učinaka je stimulacija preostalog tkiva štitnjače da nakuplja jod koji je važan za pretragu radioaktivnim jodom.
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.
Podaci o kinetici radioaktivnog joda ukazuju na to da je njegov klirens približno 50% veći u eutireozi nego u stanju hipotireoze, u kojemu je funkcija bubrega smanjena, što dovodi do manje retencije radioaktivnog joda u tijelu u vrijeme scintigrafije.
Thyrogen should only be administered into the buttock muscle.
Thyrogen se treba primijeniti samo u mišić stražnjice.
As assessed by radioiodine imaging and stimulated Tg levels (n = 421), ablation success rates were approximately 86% in all four treatment groups.
Prema nalazima radiojodne scintigrafije i razinama Tg nakon stimulacije (n = 421), stopa uspješnosti ablacije iznosila je približno 86% u sve četiri terapijske skupine.
Quality of life was significantly reduced following thyroid hormone withdrawal, but maintained following either dosage regimen of Thyrogen in both indications.
Kvaliteta života bolesnika značajno se smanjila nakon prekida terapije tireoidnim hormonom, dok je bila održana pri oba režima doziranja lijeka Thyrogen u obje indikacije.
Formal interaction studies between Thyrogen and other medicinal products have not been performed.
Nisu provedena formalna ispitivanja interakcija lijeka Thyrogen s drugim lijekovima.
Clear Type I glass 5 ml vials.
Prozirne staklene bočice (staklo tip I) od 5 ml.
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.
Tg autoprotutijela može se očekivati u 18-40% bolesnika s diferenciranim karcinomom štitnjače i može biti razlogom lažno negativnog nalaza mjerenja tireoglobulina u serumu.
Recurrence rate (5 years) Recurrence rate (7 years)
Stopa povrata bolesti (3 godine) Stopa povrata bolesti (5 godina) Stopa povrata bolesti (7 godina)
Thyrogen powder must be dissolved in water for injection.
Thyrogen prašak mora se otopiti u vodi za injekcije.
Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen).
Dijagnostičko snimanje mora se obaviti 48 do 72 sata nakon davanja radioaktivnog joda (72 do 96 sati nakon zadnje injekcije lijeka Thyrogen).
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth.
Postoji teoretska mogućnost da Thyrogen, kao i prekid terapije tireoidnim hormonom, može dovesti do stimuliranja rasta tumora.
Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue.
Stoga je potrebno pažljivo procijeniti odnos rizika i koristi u svakog pojedinog bolesnika sa značajnim ostatnim tkivom štitnjače.
It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity.
Nije poznato može li Thyrogen primijenjen u trudnica naštetiti plodu ili utjecati na reproduktivnu sposobnost.
Low activity dose RAI (1.1 GBq)
Doza radioaktivnog joda niske aktivnosti (1,1 GBq)
It has comparable biochemical properties to natural human Thyroid Stimulating Hormone (TSH).
Njegova su biokemijska svojstva usporediva sa svojstvima prirodnog humanog hormona koji stimulira štitnjaču (TSH).
What you need to know before you use Thyrogen
Što morate znati prije nego počnete primjenjivati Thyrogen
This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging.
Tu činjenicu treba uzeti u obzir kada se određuje aktivnost radioaktivnog joda potrebna za radiojodnu scintigrafiju.
Pack sizes: one or two vials of Thyrogen per carton.
Veličine pakiranja: jedna ili dvije bočice lijeka Thyrogen u kutiji.
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.
Dva su bolesnika imala mučninu nakon primjene i.m. doze od 2,7 mg, a u jednoga od njih uz mučninu su se javili i slabost, omaglica i glavobolja.
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.
Taj je bolesnik primio 0,3 mg lijeka Thyrogen u obliku jednokratnog intravenskog (i.v.) bolusa te je nakon 15 minuta imao jaku mučninu, povraćanje, znojenje, hipotenziju i tahikardiju.
Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen
Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Thyrogen:
Your treatment should be supervised by a doctor who has expertise in thyroid cancer.
Liječenje mora nadgledati liječnik s iskustvom u liječenju karcinoma štitnjače.
In summary, these studies support the efficacy of low activity radioiodine plus thyrotropin alpha (with reduced radiation exposure).
Sažeto, ova ispitivanja dokazuju djelotvornost radioaktivnog joda niske aktivnosti i tireotropina alfa (sa smanjenom izloženošću zračenju).
It is possible that Thyrogen may also cause tumour growth.
Postoji mogućnost da i Thyrogen izaziva rast tumora.
Thyrogen should not be administered intravenously.
Thyrogen se ne smije primijeniti intravenski.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Paasheuvelweg 25, 1105 BP Amsterdam Nizozemska
This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Smatralo se da je to povezano s povećanim vrijednostima hormona koji stimulira štitnjaču (TSH) tijekom duljeg vremena.
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.
Podaci dobiveni praćenjem nakon stavljanja lijeka u promet kao i objavljeni podaci ukazuju da je eliminacija lijeka Thyrogen značajno sporija u bolesnika u terminalnoj fazi bubrežne bolesti ovisnih o dijalizi, što rezultira produljenim povišenjem vrijednosti hormona koji stimulira štitnjaču (TSH) tijekom nekoliko dana nakon liječenja.
In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Bolesnike s dobro diferenciranim karcinomom štitnjače podvrgava se gotovo potpunoj ili potpunoj tireoidektomiji.
Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.
Liječnik ili medicinska sestra će Vam ubrizgati 1,0 ml Thyrogen otopine.
Package size: one or two vials per carton.
Veličina pakiranja: jedna ili dvije bočice u kutiji.
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.
popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Do not shake the solution.
Ne tresite otopinu.
It is not known whether Thyrogen can affect fertility in humans.
Plodnost Nije poznato može li Thyrogen utjecati na plodnost u ljudi.
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.
Nuspojave navedene u tablici objedinjuju nuspojave iz šest prospektivnih kliničkih ispitivanja (N=481) i nuspojave prijavljene tvrtki Genzyme nakon davanja odobrenja za stavljanje u promet lijeka Thyrogen.
The pH of the Thyrogen solution is approximately 7.0.
pH vrijednost Thyrogen otopine je približno 7,0.
Shelf-life after reconstitution
Rok valjanosti nakon rekonstitucije
It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left.
Također stimulira stvaranje tireoglobulina i hormona štitnjače ako je preostao dio tkiva štitnjače.
The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Farmakokinetika lijeka Thyrogen ispitivana je u bolesnika s dobro diferenciranim karcinomom štitnjače nakon jedne intramuskularne injekcije u dozi od 0,9 mg.
Your medicine will be injected by a doctor or a nurse.
Vaš liječnik ili medicinska sestra.
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.
Bolesnici koji su slučajno primili previše lijeka Thyrogen prijavili su mučninu, slabost, omaglicu, glavobolju, povraćanje i navale vrućine.
Skin and subcutaneous tissue disorders urticaria, rash pruritus, hyperhidrosis
Poremećaji kože i potkožnog tkiva urtikarija, osip pruritus, hiperhidroza
• if you have reduced kidney function and he will decide how much radioiodine to give you.
• ako imate oslabljenu funkciju bubrega, a liječnik će odlučiti koliko radioaktivnog joda trebate primiti.
In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
U kliničkim ispitivanjima nisu zamijećene interakcije prilikom istodobne primjene lijeka Thyrogen i hormona štitnjače trijodtironina (T3) i tiroksina (T4).
Musculoskeletal and connective tissue disorder neck pain, back pain arthralgia, myalgia
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u vratu, bol u leđima artralgija, mialgija
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.
Uobičajen pristup za postizanje povišene razine TSH-a je bio prekid supresijske terapije tireoidnim hormonom, što u bolesnika obično izaziva simptome i znakove hipotireoze.
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.
Poznato je da Thyrogen uzrokuje prolazan ali značajan porast koncentracije hormona štitnjače u serumu kada se primijeni u bolesnika koji još uvijek imaju znatniju količinu tkiva štitnjače in situ.
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.
U svih 28 bolesnika (100%) liječenih nakon prekida supresijske terapije tireoidnim hormonom te u svih 32 bolesnika (100%) liječenih nakon primjene lijeka Thyrogen ili nije bilo vidljivog nakupljanja radioaktivnog joda u ležištu štitnjače ili ono, ako je bilo vidljivo, nije premašilo < 0,1% primijenjene aktivnosti radioaktivnog joda.
How to store Thyrogen
Kako primjenjivati Thyrogen
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.
U kliničkim ispitivanjima otkrivanja ostatnog tkiva štitnjače ili karcinoma u bolesnika nakon provedene ablacije, primjenom tireoglobulinskog testa s donjom granicom detekcije od 0,5 ng/ml, razine tireoglobulina nakon stimulacije lijekom Thyrogen od 3 ng/ml, 2 ng/ml odnosno 1 ng/ml odgovarale su razinama tireoglobulina nakon prekida terapije tireoidnim hormonom od 10 ng/ml, 5 ng/ml odnosno 2 ng/ml.
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.
Nakon stimulacije lijekom Thyrogen vrijednosti tireoglobulina bile su iznad 2 ng/ml u svih 35 bolesnika, dok su uz primjenu supresijske terapije tireoidnim hormonom one bile iznad 2 ng/ml u 79% navedenih bolesnika.
The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded.
Ne može se isključiti stvaranje protutijela koja bi mogla interferirati s određivanjem vrijednosti endogenog TSH-a provedenog tijekom redovitog praćenja.
For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Za dijagnostičko praćenje tireoglobulina (Tg) u serumu, uzorak seruma mora se uzeti 72 sata nakon zadnje injekcije lijeka Thyrogen.
Mannitol
• manitol
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.
ispitivanju ESTIMABL1 randomizirana su 752 bolesnika s tumorom štitnjače niskog rizika (stadiji tumora pT1 < 1 cm i N1 ili Nx, pT1 > 1-2 cm i bilo koji stadij
Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.
Nakon primjene lijeka Thyrogen neki bolesnici mogu osjetiti omaglicu ili glavobolju, što može utjecati na sposobnost upravljanja vozilima i strojevima.
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.
Uspješnost ablacije ostatnoga tkiva štitnjače ocjenjivala se i temeljem kriterija razine Tg u serumu nakon stimulacije lijekom Thyrogen od < 2 ng/ml osam mjeseci nakon ablacije, ali samo u bolesnika s negativnim nalazom interferirajućih anti-Tg protutijela.
There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population.
Ne postoje istraživanja o alternativnim režimima doziranja lijeka Thyrogen u bolesnika u terminalnoj fazi bubrežne bolesti na temelju kojih bi se definiralo smanjenje doze u toj populaciji.
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.
U usporednom ispitivanju koje je obuhvatilo 60 bolesnika dostupnih za procjenu, stopa uspješnosti ablacije ostatnog tkiva štitnjače radioaktivnim jodom aktivnosti 100 mCi/3,7 GBq (± 10%) u bolesnika s karcinomom štitnjače nakon učinjene tireoidektomije bila je usporediva u bolesnika liječenih nakon prekida terapije tireoidnim hormonom i nakon primjene lijeka Thyrogen.
One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Još je jedan bolesnik uključen u kliničko ispitivanje imao simptome nakon intravenske primjene lijeka
HiLo study recurrence rates in patients who received low or high dose activity RAI
Tablica 2. Stopa povrata bolesti u ispitivanju HiLo u bolesnika koji su primili dozu radioaktivnog joda niske ili visoke aktivnosti
Both dose regimens were effective and not statistically different from thyroid hormone withdrawal in stimulating radioiodine uptake for diagnostic imaging.
Oba režima doziranja bila su djelotvorna i nisu se statistički razlikovala od prekida terapije tireoidnim hormonom s obzirom na stimulaciju nakupljanja radioaktivnog joda radi provođenja dijagnostičke pretrage.
It is recommended that the Thyrogen solution be injected within three hours after reconstitution.
Preporučuje se ubrizgati otopinu lijeka Thyrogen unutar tri sata nakon rekonstitucije.
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.
Za optimalnu dijagnozu ostatnoga tkiva ili karcinoma štitnjače bilo radiojodnom scintigrafijom ili mjerenjem tireoglobulina kao i za radiojodnu terapiju ostatnog tkiva štitnjače potrebna je visoka razina TSH-a u serumu, kako bi se stimuliralo nakupljanje radioaktivnog joda i/ili otpuštanje tireoglobulina.
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).
30 mCi (1,1 GBq) do 100 mCi (3,7 GBq) za ablaciju ostatnog tkiva štitnjače u bolesnika nakon gotovo potpune ili potpune tireoidektomije zbog dobro diferenciranog karcinoma štitnjače u kojih nema dokaza o udaljenim metastazama karcinoma štitnjače (vidjeti dio 4.4).
Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues.
Farmakoterapijska skupina: Hormoni hipofize i hipotalamusa i analozi.
Thyrogen contains the active substance thyrotropin alfa.
Thyrogen sadrži djelatnu tvar tireotropin alfa.
The Thyrogen solution should be a clear, colourless solution.
Otopina lijeka Thyrogen mora biti bistra i bezbojna otopina.
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.
Nakon rekonstitucije s 1,2 ml vode za injekciju, izvuče se 1,0 ml otopine (što odgovara 0,9 mg lijeka Thyrogen) i primijeni bolesniku.
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodiumfree'.
Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po injekciji, tj. zanemarive količine natrija.
• impaired sense of taste (dysgeusia)
• poremećen osjet okusa (disgeuzija)
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.
Glavni cilj praćenja bio je potvrditi stanje ablacije ostatnog tkiva štitnjače uz pomoć statičke radiojodne scintigrafije vrata stimulirane lijekom Thyrogen, nakon medijana praćenja od 3,7 godina
• flu symptoms
• osip • simptomi gripe
Nervous system disorders dizziness, headache ageusia, dysgeusia, paraesthesia stroke, tremor
Poremećaji živčanog sustava omaglica, glavobolja ageuzija, disgeuzija,
Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Jedna bočica sadrži 0,9 mg/ml tireotropina alfa kada se pripremi za primjenu s 1,2 ml vode za injekciju.
Very rare cases of hyperthyroidism or atrial fibrillation have been observed when Thyrogen 0.9 mg has been administered in patients with presence of either partial or entire thyroid gland.
Opis odabranih nuspojava Zabilježeni su vrlo rijetki slučajevi hipertireoze ili fibrilacije atrija kad je Thyrogen 0,9 mg primijenjen u bolesnika koji imaju dio štitnjače ili cijelu štitnjaču.
The following effects have been reported with Thyrogen:
Zabilježene su sljedeće nuspojave lijeka Thyrogen:
Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 ± 1 months after treatment.
Uspješnost ablacije ostatnoga tkiva ocjenjivala se radiojodnom scintigrafijom i određivanjem koncentracije tireoglobulina u serumu 8 ± 1 mjeseci nakon provedenog liječenja.