FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes: one or two vials of Thyrogen per carton.
Croatian: Veličine pakiranja: jedna ili dvije bočice lijeka Thyrogen u kutiji.
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.
Croatian: 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.
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.
Croatian: 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.
English: Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Thyrogen:
English: Your treatment should be supervised by a doctor who has expertise in thyroid cancer.
Croatian: Liječenje mora nadgledati liječnik s iskustvom u liječenju karcinoma štitnjače.
English: In summary, these studies support the efficacy of low activity radioiodine plus thyrotropin alpha (with reduced radiation exposure).
Croatian: Sažeto, ova ispitivanja dokazuju djelotvornost radioaktivnog joda niske aktivnosti i tireotropina alfa (sa smanjenom izloženošću zračenju).
English: It is possible that Thyrogen may also cause tumour growth.
Croatian: Postoji mogućnost da i Thyrogen izaziva rast tumora.
English: Thyrogen should not be administered intravenously.
Croatian: Thyrogen se ne smije primijeniti intravenski.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Croatian: Paasheuvelweg 25, 1105 BP Amsterdam Nizozemska
English: This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period.
Croatian: Smatralo se da je to povezano s povećanim vrijednostima hormona koji stimulira štitnjaču (TSH) tijekom duljeg vremena.
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.
Croatian: 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.
English: In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Croatian: Bolesnike s dobro diferenciranim karcinomom štitnjače podvrgava se gotovo potpunoj ili potpunoj tireoidektomiji.
English: Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.
Croatian: Liječnik ili medicinska sestra će Vam ubrizgati 1,0 ml Thyrogen otopine.
English: Package size: one or two vials per carton.
Croatian: Veličina pakiranja: jedna ili dvije bočice u kutiji.
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.
Croatian: popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Do not shake the solution.
Croatian: Ne tresite otopinu.
English: It is not known whether Thyrogen can affect fertility in humans.
Croatian: Plodnost Nije poznato može li Thyrogen utjecati na plodnost u ljudi.
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.
Croatian: 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.
English: The pH of the Thyrogen solution is approximately 7.0.
Croatian: pH vrijednost Thyrogen otopine je približno 7,0.
English: Shelf-life after reconstitution
Croatian: Rok valjanosti nakon rekonstitucije
English: It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left.
Croatian: Također stimulira stvaranje tireoglobulina i hormona štitnjače ako je preostao dio tkiva štitnjače.
English: The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Croatian: Farmakokinetika lijeka Thyrogen ispitivana je u bolesnika s dobro diferenciranim karcinomom štitnjače nakon jedne intramuskularne injekcije u dozi od 0,9 mg.
English: Your medicine will be injected by a doctor or a nurse.
Croatian: Vaš liječnik ili medicinska sestra.
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.
Croatian: Bolesnici koji su slučajno primili previše lijeka Thyrogen prijavili su mučninu, slabost, omaglicu, glavobolju, povraćanje i navale vrućine.
English: Skin and subcutaneous tissue disorders urticaria, rash pruritus, hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva urtikarija, osip pruritus, hiperhidroza
English: • if you have reduced kidney function and he will decide how much radioiodine to give you.
Croatian: • ako imate oslabljenu funkciju bubrega, a liječnik će odlučiti koliko radioaktivnog joda trebate primiti.
English: In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
Croatian: U kliničkim ispitivanjima nisu zamijećene interakcije prilikom istodobne primjene lijeka Thyrogen i hormona štitnjače trijodtironina (T3) i tiroksina (T4).
English: Musculoskeletal and connective tissue disorder neck pain, back pain arthralgia, myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u vratu, bol u leđima artralgija, mialgija
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.
Croatian: Uobičajen pristup za postizanje povišene razine TSH-a je bio prekid supresijske terapije tireoidnim hormonom, što u bolesnika obično izaziva simptome i znakove hipotireoze.
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.
Croatian: 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.
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.
Croatian: 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.
English: How to store Thyrogen
Croatian: Kako primjenjivati 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.
Croatian: 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.
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.
Croatian: 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.
English: The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded.
Croatian: Ne može se isključiti stvaranje protutijela koja bi mogla interferirati s određivanjem vrijednosti endogenog TSH-a provedenog tijekom redovitog praćenja.
English: For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Croatian: Za dijagnostičko praćenje tireoglobulina (Tg) u serumu, uzorak seruma mora se uzeti 72 sata nakon zadnje injekcije lijeka Thyrogen.
English: Mannitol
Croatian: • manitol
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.
Croatian: 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
English: Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.
Croatian: Nakon primjene lijeka Thyrogen neki bolesnici mogu osjetiti omaglicu ili glavobolju, što može utjecati na sposobnost upravljanja vozilima i strojevima.
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.
Croatian: 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.
English: There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population.
Croatian: 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.
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.
Croatian: 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.
English: One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.
Croatian: Još je jedan bolesnik uključen u kliničko ispitivanje imao simptome nakon intravenske primjene lijeka
English: HiLo study recurrence rates in patients who received low or high dose activity RAI
Croatian: Tablica 2. Stopa povrata bolesti u ispitivanju HiLo u bolesnika koji su primili dozu radioaktivnog joda niske ili visoke aktivnosti
English: Both dose regimens were effective and not statistically different from thyroid hormone withdrawal in stimulating radioiodine uptake for diagnostic imaging.
Croatian: 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.
English: It is recommended that the Thyrogen solution be injected within three hours after reconstitution.
Croatian: Preporučuje se ubrizgati otopinu lijeka Thyrogen unutar tri sata nakon rekonstitucije.
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.
Croatian: 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.
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).
Croatian: 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).
English: Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues.
Croatian: Farmakoterapijska skupina: Hormoni hipofize i hipotalamusa i analozi.
English: Thyrogen contains the active substance thyrotropin alfa.
Croatian: Thyrogen sadrži djelatnu tvar tireotropin alfa.
English: The Thyrogen solution should be a clear, colourless solution.
Croatian: Otopina lijeka Thyrogen mora biti bistra i bezbojna otopina.
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.
Croatian: 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.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodiumfree'.
Croatian: Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po injekciji, tj. zanemarive količine natrija.
English: • impaired sense of taste (dysgeusia)
Croatian: • poremećen osjet okusa (disgeuzija)
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.
Croatian: 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
English: • flu symptoms
Croatian: • osip • simptomi gripe
English: Nervous system disorders dizziness, headache ageusia, dysgeusia, paraesthesia stroke, tremor
Croatian: Poremećaji živčanog sustava omaglica, glavobolja ageuzija, disgeuzija,
English: Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Croatian: Jedna bočica sadrži 0,9 mg/ml tireotropina alfa kada se pripremi za primjenu s 1,2 ml vode za injekciju.
English: 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.
Croatian: 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.
English: The following effects have been reported with Thyrogen:
Croatian: Zabilježene su sljedeće nuspojave lijeka Thyrogen:
English: Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 ± 1 months after treatment.
Croatian: Uspješnost ablacije ostatnoga tkiva ocjenjivala se radiojodnom scintigrafijom i određivanjem koncentracije tireoglobulina u serumu 8 ± 1 mjeseci nakon provedenog liječenja.
English: • Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na goveđi ili ljudski hormon koji stimulira štitnjaču ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Trudnoća (vidjeti dio 4.6).
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.
Croatian: Zbog povišenja razine TSH-a nakon primjene lijeka Thyrogen u bolesnika s metastatskim karcinomom štitnjače, a naročito u anatomski zatvorenim područjima kakva su mozak, kralježnična moždina i očna šupljina, ili u slučaju infiltracije struktura vrata, može doći do razvoja lokalnog edema ili žarišnog krvarenja na mjestu spomenutih metastaza, što dovodi do povećanja tumora.
English: Thyrogen is used to detect certain types of thyroid cancer in patients who have had their thyroid gland removed and who are taking thyroid hormones.
Croatian: Thyrogen se primjenjuje za otkrivanje određenih vrsta karcinoma štitnjače u bolesnika kojima je uklonjena štitna žlijezda i koji uzimaju hormone štitnjače.
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.
Croatian: Zbog povećanih vrijednosti TSH-a nakon primjene lijeka Thyrogen u bolesnika sa sekundarnim rastom karcinoma (metastazama) može doći do lokalnog oticanja tkiva ili do krvarenja na mjestima metastaza koje se mogu povećati.
English: Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Croatian: Potrebno je izvući samo 1 ml, što odgovara 0,9 mg tireotropina alfa.
English: Please talk to your doctor about this if you have concerns.
Croatian: Ako ste zabrinuti zbog toga, molimo obratite se svom liječniku.
English: All patients considered ablated in the initial study were confirmed to be ablated in the follow-up study.
Croatian: Za sve bolesnike u kojih je u inicijalnom ispitivanju ablacija ocijenjena uspješnom, potvrđena je ablacija u kontrolnom ispitivanju.
English: The recommended dose of Thyrogen is two doses administered 24 hours apart.
Croatian: Preporučeno doziranje lijeka Thyrogen su dvije doze primijenjene u razmaku od 24 sata.
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.
Croatian: U posebnom je programu liječenja jedan 77-godišnji bolesnik s metastatskim karcinomom štitnjače, koji nije bio podvrgnut tireoidektomiji, primio 4 doze od 0,9 mg lijeka Thyrogen u
English: The major elimination route of thyrotropin alfa is believed to be renal and to a lesser extent hepatic.
Croatian: Pretpostavlja se da je glavni put eliminacije tireotropina alfa bubrezima, a manjim dijelom jetrom.
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.
Croatian: Prema tom je kriteriju ablacija ostatnog tkiva štitnjače provedena uspješno u 18/21 bolesnika (86%) u skupini u kojoj je prekinuta supresijska terapija tireoidnim hormonom te u 23/24 bolesnika (96%) u skupini u kojoj je primijenjen Thyrogen.
English: It is not recommended to perform TSH assays after Thyrogen administration.
Croatian: Ne preporučuje se određivanje vrijednosti TSH-a nakon primjene lijeka Thyrogen.
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.
Croatian: Primjena u dijagnostici Djelotvornost i sigurnost lijeka Thyrogen primijenjenog uz radiojodnu scintigrafiju istodobno s određivanjem tireoglobulina u serumu u svrhu otkrivanja ostatnog tkiva štitnjače i karcinoma štitnjače dokazane su u dva ispitivanja.
English: These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms.
Croatian: One su obuhvaćale urtikariju, osip, pruritus, navale crvenila te znakove i simptome dišnog sustava.
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.
Croatian: Pri oba se režima doziranja poboljšala osjetljivost, preciznost i negativna prediktivna vrijednost određivanja tireoglobulina u serumu nakon stimulacije lijekom Thyrogen sa ili bez radiojodne scintigrafije, u usporedbi s određivanjem tireoglobulina u bolesnika koji su nastavili primati hormone štitnjače.
English: After reconstitution with water for injection, 1.0 ml solution (0.9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock.
Croatian: Nakon rekonstitucije s vodom za injekcije, 1,0 ml otopine (0,9 mg tireotropina alfa) primjenjuje se intramuskularnom injekcijom u mišić stražnjice.
English: Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa.
Croatian: Jedna bočica lijeka Thyrogen sadrži nominalnu vrijednost od 0,9 mg tireotropina alfa.
English: In summary, in the pivotal study and its follow-up study, Thyrogen was non-inferior to thyroid hormone withdrawal for elevation of TSH levels for pre-therapeutic stimulation in combination with radioiodine for post-surgical ablation of remnant thyroid tissue.
Croatian: Sažeto, u pivotalnom ispitivanju i praćenju nakon njega Thyrogen nije bio inferioran prekidu terapije tireoidnim hormonom u podizanju razine TSH-a za predterapijsku stimulaciju u kombinaciji s radioaktivnim jodom u svrhu poslijeoperacijske ablacije ostatnog tkiva štitnjače.
English: OUTER CARTON - PACK OF 1 VIAL OUTER CARTON - PACK OF 2 VIALS
Croatian: KUTIJA - PAKIRANJE OD 1 BOČICE
English: The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only.
Croatian: Doziranje Preporučeni režim doziranja su dvije doze tireotropina alfa od 0,9 mg primijenjene u razmaku od 24 sata isključivo intramuskularnom injekcijom.
English: In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures.
Croatian: U bolesnika s karcinomom štitnjače prijavljen je rast tumora tijekom razdoblja prekida uzimanja hormona štitnjače zbog dijagnostičkih pretraga.
English: OTHER
Croatian: NL
English: Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
Croatian: Nakon rekonstitucije, jedna bočica lijeka Thyrogen sadrži 0,9 mg tireotropina alfa u 1,0 ml.