natgillin/translations-raw huggingface dataset:
The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection.
Farmakokinetične lastnosti zdravila Thyrogen so bile raziskane pri bolnikih z dobro diferenciranim rakom ščitnice po enkratnem 0,9 mg intramuskularnem injiciranju.
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.
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.
Dispose of any unused solution immediately.
Neuporabljeno raztopino nemudoma zavrzite.
In patients with well-differentiated thyroid cancer, a near total or total thyroidectomy is performed.
Pri bolnikih z dobro diferenciranim rakom ščitnice se ščitnica skoraj popolnoma ali popolnoma odstrani.
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).
Vezava tirotropina alfa na receptorje TSH epitelnih celic ščitnice stimulira privzemanje in organifikacijo joda ter sintezo in sproščanje tiroglobulina, trijodotironina (T3) in tiroksina (T4).
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.
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.
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.
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).
Effect on tumour growth
Vpliv na rast tumorjev
• flu symptoms
• gripi podobni simptomi
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.
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.
Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Thyrogen se posvetujte z zdravnikom ali farmacevtom
Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.
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.
It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect reproductive capacity.
Ni znano, ali zdravilo Thyrogen, ki ga dobi nosečnica, lahko škoduje plodu in ali lahko vpliva na zmožnost razmnoževanja.
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.
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.
False negative results may occur with Thyrogen.
Z zdravilom Thyrogen lahko dobimo tudi lažno negativne rezultate.
Both dose regimens were effective and not statistically different from thyroid hormone withdrawal in stimulating radioiodine uptake for diagnostic imaging.
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.
Your treatment should be supervised by a doctor who has expertise in thyroid cancer.
Vaše zdravljenje naj nadzoruje zdravnik z izkušnjami s področja raka ščitnice.
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.
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.
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.
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.
To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Da bi bilo vsakič na voljo dovolj prostornine za natančen odmerek, vsebuje vsaka viala zdravila Thyrogen 0,2 ml presežka.
A follow-up study was conducted on patients who previously completed the initial study, and data is available for 51 patients.
Spremljevalna študija se je izvajala z bolniki, ki so pred tem zaključili začetno študijo.
Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes.
Zdravilo Thyrogen je humani ščitnico stimulirajoči hormon (TSH), ki se izdeluje v biotehnološkem postopku.
I, thyroid hormone withdrawal + 30 mCi
, odstranitev tiroidnega hormona + 30 mCi
Thyrogen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Zdravila Thyrogen vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni “brez natrija”.
There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.
Ni znanega medsebojnega delovanja drugih zdravil z zdravilom Thyrogen in ščitnico stimulirajočimi hormoni, ki jih morda jemljete.
The HiLo study randomised 438 patients (tumour stages T1-T3, Nx, N0 and N1, M0) at 29 centres.
V študiji HiLo je bilo v 29 raziskovalnih centrih naključno razporejenih 438 bolnikov (s stadiji tumorja T1-T3, Nx, N0 in N1, M0).
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.
Rekonstituirano raztopino lahko shranjujete do 24 ur v hladilniku (2 °C - 8 °C), zaščiteno pred svetlobo.
Musculoskeletal and connective tissue disorder neck pain, back pain arthralgia, myalgia
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v vratu, bolečine v hrbtu artralgija, mialgija
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.
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
In these studies the use of thyroglobulin testing on Thyrogen was found to be more sensitive than thyroglobulin testing on TSHT.
V teh študijah so se testiranja tiroglobulina z zdravilom Thyrogen izkazali za občutljivejše od tistih s THST.
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.
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.
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
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
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.
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.
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.
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.
Therefore, both TgAb and Tg assays are needed.
Zato je potrebno določanje vrednosti tako TgAb kot Tg.
Thyrogen should not be given to breast-feeding women.
Zdravila Thyrogen se ne sme dajati ženskam, ki dojijo.
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.
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.
• injection site reactions (including: redness, discomfort, itching, local pain or stinging, and an itchy rash)
• reakcije na mestu injiciranja (vključujejo: pordelost, neugodje, srbenje, lokalno bolečino ali zbadanje in srbeči izpuščaj)
Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 ± 1 months after treatment.
Uspešnost ablacije ostankov se je ocenjevala s scintigrafijo z radioaktivnim jodom in s testiranjem tiroglobulina v serumu 8 ± 1 mesecev po zdravljenju.
Thyrogen powder must be dissolved in water for injection.
Prašek zdravila Thyrogen mora biti raztopljen v vodi za injekcije.
A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
V primeru prevelikega odmerjanja se priporoča ponovna vzpostavitev ravnovesja tekočin v telesu in eventualno uporaba antiemetika.
All patients considered ablated in the initial study were confirmed to be ablated in the follow-up study.
Pri vseh bolnikih, pri katerih je bila ablacija ocenjena kot uspešna v prvotni študiji, je bil uspeh ablacije potrjen tudi v spremljevalni študiji.
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.
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.
What Thyrogen looks like and contents of the pack
Izgled zdravila Thyrogen in vsebina pakiranja
Package size: one or two vials per carton.
Velikost pakiranja: Škatla z eno ali dvema vialama.
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.
Po rekonstituciji z 1,2 ml vode za injekcije se 1,0 ml raztopine (enakovredno 0,9 mg zdravila Thyrogen) odvzame in injicira bolniku.
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 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.
Metastatic disease was confirmed by a post-treatment scan or by lymph node biopsy in 35 patients.
S slikanjem po zdravljenju ali z biopsijo limfnih vozlov so metastatsko bolezen potrdili pri 35 bolnikih.
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).
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).
Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology.
Tirotropin alfa (rekombinantni humani ščitnico stimulirajoči hormon) je heterodimerni glikoprotein, izdelan s tehnologijo rekombinantne DNA.
In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
Med kliničnimi preskušanji pri sočasnem dajanju niso bile zaznane nikakršne interakcije med zdravilom Thyrogen in tiroidnimi hormoni trijodotironinom (T3) in tiroksinom (T4).
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.
Kadar uporabljamo kombinacijo scintigrafije celotnega telesa (WBS - Whole Body Scintigraphy) in testiranja Tg kot alternativo odstranitvi tiroidnega hormona, po dajanju zdravila Thyrogen le-ta zagotavlja najvišjo stopnjo občutljivosti pri zaznavanju tiroidnih ostankov ali raka.
Recurrence rate (5 years) Recurrence rate (7 years)
Delež ponovitev (7 let)
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.
Če povzamemo, v okviru osrednje študije in spremljevalne študije zdravilo Thyrogen ni bilo slabše kot prekinitev tiroidnega hormona za dvig ravni TSH z namenom predterapevtske stimulacije v kombinaciji z radioaktivnim jodom za pooperacijsko ablacijo preostalega tiroidnega tkiva.
In patients with thyroid cancer, several cases of stimulated tumour growth have been reported during withdrawal of thyroid hormones for diagnostic procedures which have been attributed to the associated prolonged elevation of TSH levels.
Pri bolnikih z rakom ščitnice več primerov stimulirane rasti tumorjev, poročanih med odstranitvijo tiroidnih hormonov v diagnostične namene, pripisujejo s tem povezanim podaljšanim povišanjem ravni TSH.
How to use Thyrogen
Kako uporabljati zdravilo Thyrogen
Thyrogen should not be used during breast-feeding.
Zdravilo Thyrogen se med dojenjem ne sme uporabljati.
Therapy should be supervised by physicians with expertise in thyroid cancer.
Zdravljenje morajo nadzorovati zdravniki z izkušnjami s področja raka ščitnice.
With the use of Thyrogen, the TSH stimulation necessary for radioiodine uptake and thyroglobulin release is achieved while patients are maintained euthyroid on THST, thus avoiding the morbidity associated with hypothyroidism.
Z uporabo zdravila Thyrogen dosežemo stimulacijo TSH, potrebno za privzem radioaktivnega joda in sproščanje tiroglobulina medtem, ko so bolniki evtirotični med zdravljenjem s THST in se tako izognemo morbidnosti, povezani s hipotiroidizmom.
Thyrogen must not be mixed with other medicines in the same injection.
Raztopine se ne sme nikoli injicirati v veno.Zdravila Thyrogen se ne sme mešati z drugimi zdravili v isti injekciji.
Name and address of the manufacturers responsible for batch release
Ime in naslov proizvajalca, odgovornega za sproščanje serij
It is not known whether Thyrogen can affect fertility in humans.
Plodnost Ni znano, ali lahko zdravilo Thyrogen vpliva na plodnost pri človeku.
The recommended dose of Thyrogen is two doses administered 24 hours apart.
Priporočeni odmerek zdravila Thyrogen sta dva odmerka, dana v razmaku 24 ur.
Shelf-life after reconstitution
Rok uporabnosti po rekonstituciji
In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures.
Pri bolnikih z rakom ščitnice poročajo o rasti tumorjev med odstranitvijo ščitničnih hormonov v diagnostične namene.
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).
Zdravilo Thyrogen je indicirano za uporabo pri testiranju tiroglobulina (Tg) v serumu z ali brez scintigrafije z radioaktivnim jodom za odkrivanje tiroidnih ostankov in dobro diferenciranega raka ščitnice pri bolnikih, ki se po tiroidektomiji zdravijo s hormonsko supresivno terapijo (THST - thyroid hormone suppression therapy).
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.
V posebnem programu zdravljenja je 77-letni bolnik z metastatičnim rakom ščitnice, kateremu ščitnice niso odstranili, v 6-ih dneh prejel 4 odmerke zdravila Thyrogen 0,9 mg.
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.
Zaradi zvišanja ravni TSH po uporabi zdravila Thyrogen se lahko pri bolnikih s sekundarnimi rakavimi zasevki (metastazami) pojavi lokalna oteklina ali krvavitev na mestu teh zasevkov, ki se lahko zvečajo.
HiLo study recurrence rates in patients who received low or high dose activity RAI
Deleži ponovitev pri bolnikih, ki so prejeli nizko ali visoko aktivnost radioaktivnega joda (RAI), v študiji HiLo
• muscle or joint pain
• bolečine mišic ali sklepov
Thyrogen is also used with radioiodine treatment to eliminate (ablate) the thyroid tissue left over after surgical removal of the thyroid gland (remnant) in patients who do not have secondary cancer growths (metastases) and who are taking thyroid hormone.
Zdravilo Thyrogen se uporablja tudi pri zdravljenju z radioaktivnim jodom za izločanje (ablacijo) ščitničnega tkiva, ki ostane po kirurški odstranitvi žleze ščitnice (ostankov) pri bolnikih, ki nimajo sekundarnega obolenja (zasevkov) in ki jemljejo ščitnični hormon.
Patients with renal/hepatic impairment
Bolniki z okvaro ledvic/jeter
• low TSH
• nizka raven TSH
If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered.
Če obstaja močan sum metastatske bolezni, razmislite o potrdilnem WBS in testiranju Tg po odstranitvi tiroidnega hormona.
Thyrogen-stimulated thyroglobulin testing was also performed.
Opravili so tudi testiranje z zdravilom Thyrogen stimulirane ravni tiroglobulina.
• inability to taste (ageusia)
• izguba zmožnosti okušanja (agevzija)
• hives (urticaria)
• srbenje (pruritis)
Thyrogen should not be administered intravenously.
Zdravila Thyrogen ne smemo dajati intravensko.
Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Ena viala vsebuje 0,9 mg/ml tirotropina alfa, po rekonstituciji z 1,2 ml vode za injekcije.
Any unused solution should be discarded.
Samo za enkratno uporabo Neuporabljeno raztopino morate odstraniti.
It is recommended that the Thyrogen solution be injected within three hours after reconstitution.
Priporočeno je, da raztopino zdravila Thyrogen injicirate v treh urah po rekonstituciji.
Nervous system disorders dizziness, headache ageusia, dysgeusia, paraesthesia stroke, tremor
Bolezni živčevja omotica, glavobol agevzija, disgevzija,
The Thyrogen solution should be a clear, colourless solution.
Raztopina zdravila Thyrogen mora biti bistra in brezbarvna.
For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Za diagnostično testiranje tiroglobulina v serumu (Tg) moramo vzorec seruma vzeti 72 ur po zadnjem injiciranju zdravila Thyrogen.
Table 3.
Preglednica 3 .
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.
Uspešnost ablacije, ocenjena z ultrazvokom vratu in stimuliranimi ravnmi Tg (na osnovi 684 ocenjevanih bolnikov), je bila 92 % in se med štirimi skupinami ni statistično razlikovala.
2 vials of powder for solution for injection equal to 2 doses to be administered at a 24-hour interval.
2 viali praška za raztopino za injiciranje, enaki 2 odmerkoma, se dajeta v 24-urnem razmiku
• hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.
• preobčutljivost (alergijske reakcije); te reakcije vključujejo koprivnico (urtikarijo), srbenje
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.
Zdravilo Thyrogen se uporablja za odkrivanje nekaterih vrst raka ščitnice pri bolnikih, pri katerih je bila ščitnica odstranjena, in jemljejo ščitnične hormone.
It has comparable biochemical properties to natural human Thyroid Stimulating Hormone (TSH).
Tirotropin alfa ima biokemijske značilnosti, primerljive z naravnim humanim ščitnico stimulirajočim hormonom (TSH).
White to off-white lyophilised powder.
FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje Beli do umazano beli lipofilizirani prašek.
Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Odvzeti se mora samo 1 ml, kar ustreza 0,9 mg tirotropina alfa.
Respiratory, thoracic and mediastinal disorder dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja