FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine (T3) and thyroxine (T4) when administered concurrently.
Slovenian: Med kliničnimi preskušanji pri sočasnem dajanju niso bile zaznane nikakršne interakcije med zdravilom Thyrogen in tiroidnimi hormoni trijodotironinom (T3) in tiroksinom (T4).
English: When used as an alternative to thyroid hormone withdrawal, the combination of the whole body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
Slovenian: 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.
English: Recurrence rate (5 years) Recurrence rate (7 years)
Slovenian: Delež ponovitev (7 let)
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How to use Thyrogen
Slovenian: Kako uporabljati zdravilo Thyrogen
English: Thyrogen should not be used during breast-feeding.
Slovenian: Zdravilo Thyrogen se med dojenjem ne sme uporabljati.
English: Therapy should be supervised by physicians with expertise in thyroid cancer.
Slovenian: Zdravljenje morajo nadzorovati zdravniki z izkušnjami s področja raka ščitnice.
English: 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.
Slovenian: 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.
English: Thyrogen must not be mixed with other medicines in the same injection.
Slovenian: Raztopine se ne sme nikoli injicirati v veno.Zdravila Thyrogen se ne sme mešati z drugimi zdravili v isti injekciji.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: It is not known whether Thyrogen can affect fertility in humans.
Slovenian: Plodnost Ni znano, ali lahko zdravilo Thyrogen vpliva na plodnost pri človeku.
English: The recommended dose of Thyrogen is two doses administered 24 hours apart.
Slovenian: Priporočeni odmerek zdravila Thyrogen sta dva odmerka, dana v razmaku 24 ur.
English: Shelf-life after reconstitution
Slovenian: Rok uporabnosti po rekonstituciji
English: In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures.
Slovenian: Pri bolnikih z rakom ščitnice poročajo o rasti tumorjev med odstranitvijo ščitničnih hormonov v diagnostične namene.
English: Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Slovenian: 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).
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Magyarország SANOFI-AVENTIS Zrt.
Slovenian: SANOFI-AVENTIS Zrt.
English: HiLo study recurrence rates in patients who received low or high dose activity RAI
Slovenian: Deleži ponovitev pri bolnikih, ki so prejeli nizko ali visoko aktivnost radioaktivnega joda (RAI), v študiji HiLo
English: • muscle or joint pain
Slovenian: • bolečine mišic ali sklepov
English: 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.
Slovenian: 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.
English: Patients with renal/hepatic impairment
Slovenian: Bolniki z okvaro ledvic/jeter
English: • low TSH
Slovenian: • nizka raven TSH
English: If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered.
Slovenian: Če obstaja močan sum metastatske bolezni, razmislite o potrdilnem WBS in testiranju Tg po odstranitvi tiroidnega hormona.
English: Thyrogen-stimulated thyroglobulin testing was also performed.
Slovenian: Opravili so tudi testiranje z zdravilom Thyrogen stimulirane ravni tiroglobulina.
English: • inability to taste (ageusia)
Slovenian: • izguba zmožnosti okušanja (agevzija)
English: • hives (urticaria)
Slovenian: • srbenje (pruritis)
English: Thyrogen should not be administered intravenously.
Slovenian: Zdravila Thyrogen ne smemo dajati intravensko.
English: Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection.
Slovenian: Ena viala vsebuje 0,9 mg/ml tirotropina alfa, po rekonstituciji z 1,2 ml vode za injekcije.
English: Any unused solution should be discarded.
Slovenian: Samo za enkratno uporabo Neuporabljeno raztopino morate odstraniti.
English: It is recommended that the Thyrogen solution be injected within three hours after reconstitution.
Slovenian: Priporočeno je, da raztopino zdravila Thyrogen injicirate v treh urah po rekonstituciji.
English: Nervous system disorders dizziness, headache ageusia, dysgeusia, paraesthesia stroke, tremor
Slovenian: Bolezni živčevja omotica, glavobol agevzija, disgevzija,
English: The Thyrogen solution should be a clear, colourless solution.
Slovenian: Raztopina zdravila Thyrogen mora biti bistra in brezbarvna.
English: For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Slovenian: Za diagnostično testiranje tiroglobulina v serumu (Tg) moramo vzorec seruma vzeti 72 ur po zadnjem injiciranju zdravila Thyrogen.
English: Table 3.
Slovenian: Preglednica 3 .
English: Based on 684 evaluable patients, the overall ablation success rate assessed by neck ultrasounds and stimulated Tg levels was 92%, without any statistically significant difference among the four groups.
Slovenian: 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.
English: 2 vials of powder for solution for injection equal to 2 doses to be administered at a 24-hour interval.
Slovenian: 2 viali praška za raztopino za injiciranje, enaki 2 odmerkoma, se dajeta v 24-urnem razmiku
English: • hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.
Slovenian: • preobčutljivost (alergijske reakcije); te reakcije vključujejo koprivnico (urtikarijo), srbenje
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.
Slovenian: Zdravilo Thyrogen se uporablja za odkrivanje nekaterih vrst raka ščitnice pri bolnikih, pri katerih je bila ščitnica odstranjena, in jemljejo ščitnične hormone.
English: It has comparable biochemical properties to natural human Thyroid Stimulating Hormone (TSH).
Slovenian: Tirotropin alfa ima biokemijske značilnosti, primerljive z naravnim humanim ščitnico stimulirajočim hormonom (TSH).
English: White to off-white lyophilised powder.
Slovenian: FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje Beli do umazano beli lipofilizirani prašek.
English: Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
Slovenian: Odvzeti se mora samo 1 ml, kar ustreza 0,9 mg tirotropina alfa.
English: Respiratory, thoracic and mediastinal disorder dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
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.
Slovenian: bolus 0,3 mg zdravila Thyrogen, so se po 15 minutah pojavili naslednji neželeni učinki: huda navzea, bruhanje, čezmerno znojenje, hipotenzija in tahikardija.
English: It is recommended that the Thyrogen solution be injected within three hours.
Slovenian: Priporočeno je, da raztopino zdravila Thyrogen injicirate v treh urah.
English: As assessed by radioiodine imaging and stimulated Tg levels (n = 421), ablation success rates were approximately 86% in all four treatment groups.
Slovenian: Uspešnost ablacije, ocenjena s slikanjem z radioaktivnim jodom in stimuliranimi ravnmi Tg (n = 421), je bila v vseh štirih terapevtskih skupinah približno 86 % in se med štirimi skupinami ni statistično razlikovala.
English: Thyrogen contains the active substance thyrotropin alfa.
Slovenian: Zdravilo Thyrogen vsebuje zdravilno učinkovino tirotropin alfa.
English: - The active substance is thyrotropin alfa.
Slovenian: - Zdravilna učinkovina je tirotropin alfa.
English: Thyrotropin alfa was non-inferior to thyroid hormone withdrawal for pretherapeutic stimulation in combination with radioiodine for post-surgical ablation of thyroid remnant tissue.
Slovenian: Tirotropin alfa pa je bil neinferioren odtegnitvi ščitničnih hormonov kar zadeva predterapevtsko stimulacijo v kombinaciji z radioaktivnim jodom za pooperacijsko ablacijo preostalega ščitničnega tkiva.
English: Quality of life was significantly reduced following thyroid hormone withdrawal, but maintained following either dosage regimen of Thyrogen in both indications.
Slovenian: Po odstranitvi tiroidnega hormona se je kakovost življenja pomembno poslabšala, vendar je pri obeh indikacijah ne glede na režim odmerjanja tirotropina alfa ostala stabilna.
English: - If you experience any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Thyrogen should only be administered into the buttock muscle.
Slovenian: Zdravilo Thyrogen se sme injicirati samo v zadnjično mišico.
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.
Slovenian: Obe shemi odmerjanja sta v primerjavi s testi, opravljenimi, ko so bolniki dobivali tiroidne hormone, izboljšali občutljivost, natančnost in negativno napovedno vrednost z zdravilom Thyrogen stimulirane ravni tiroglobulina, samega ali v kombinaciji scintigrafije z radioaktivnim jodom.
English: • prickling or tingling sensation (paraesthesia),
Slovenian: • občutek zbadanja ali ščemenja (parestezija)
English: The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only.
Slovenian: Priporočena shema odmerjanja sta dva odmerka po 0,9 mg tirotropina alfa v razmiku 24 ur, ki ju damo samo z intramuskularno injekcijo.
English: It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Slovenian: Pri bolnikih, pri katerih lahko lokalno širjenje tumorja ogroža vitalne anatomske strukture, je priporočljivo razmisliti o predhodnem zdravljenju s kortikosteroidi.
English: Gastrointestinal disorders nausea vomiting diarrhoea
Slovenian: Bolezni prebavil navzea bruhanje diareja
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.
Slovenian: Pri tem so z zdravilom Thyrogen stimulirane ravni tiroglobulina 3 ng/ml, 2 ng/ml in 1 ng/ml ustrezale ravnem tiroglobulina po odstranitvi tiroidnih hormonov, ki so znašale 10 ng/ml, 5 ng/ml in 2 ng/ml.
English: Careful evaluation of benefit-risk relationships should be assessed for Thyrogen administration in high risk elderly patients who have heart disease (e.g. valvular heart disease, cardiomyopathy, coronary artery disease, and prior or current tachyarrhythmia including atrial fibrillation) and have not undergone thyroidectomy.
Slovenian: Pri uporabi zdravila Thyrogen pri starejših bolnikih s srčnim obolenjem (npr. bolezen srčnih zaklopk, kardiomiopatija, bolezen koronarnih arterij in predhodna ali obstoječa tahiaritmija, vključno z atrijsko fibrilacijo), pri katerih je tveganje veliko in pri njih ni bila izvedena tiroidektomija, je potrebno skrbno oceniti razmerje med koristmi in tveganjem.
English: For thyroglobulin (Tg) testing, your doctor or nurse will take a serum sample 72 hours after the last injection of Thyrogen.
Slovenian: Za testiranje tiroglobulina (Tg) zdravnik ali medicinska sestra odvzame vzorec seruma v 72 urah po zadnjem injiciranju zdravila Thyrogen.
English: Neoplasm benign, malignant and unspecified (incl.
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: It is possible that Thyrogen may also cause tumour growth.
Slovenian: Obstaja možnost, da zdravilo Thyrogen lahko povzroči rast tumorja.
English: Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
Slovenian: Po rekonstituciji vsebuje ena viala zdravila Thyrogen 0,9 mg tirotropina alfa v 1,0 ml.
English: HiLo study recurrence rates in patients who prepared for ablation with Thyrogen or Thyroid Hormone Withdrawal
Slovenian: Deleži ponovitev pri bolnikih, ki so bili pripravljeni na ablacijo z zdravilom Thyrogen ali odtegnitvijo ščitničnih hormonov, v študiji HiLo
English: After reconstitution with water for injection, 1.0 ml solution (0.9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock.
Slovenian: Po rekonstituciji z vodo za injekcije 1,0 ml raztopine (0,9 mg tirotropina alfa) injiciramo v zadnjico z intramuskularno injekcijo.
English: When you undergo radioiodine imaging or elimination (ablation), your doctor will give you radioiodine 24 hours after your final Thyrogen injection.
Slovenian: Pri slikanju z uporabo radioaktivnega joda ali izločanju (ablaciji) vam bo zdravnik dal radioaktivni jod 24 ur po prejemu zadnje injekcije zdravila Thyrogen.
English: Thyrogen 0.9 mg powder for solution for injection Thyrotropin alfa
Slovenian: Thyrogen 0,9 mg prašek za raztopino za injiciranje tirotropin alfa
English: What Thyrogen contains
Slovenian: Kaj vsebuje zdravilo Thyrogen
English: This equals 0.9 mg thyrotropin alfa to be injected.
Slovenian: To ustreza 0,9 mg tirotropina alfa za injiciranje.
English: Only one vial of Thyrogen is required per injection.
Slovenian: Za vsako injekcijo je potrebna samo ena viala zdravila Thyrogen.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride
Slovenian: Pomožne snovi: manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid
English: Withdraw 1.0 ml of the Thyrogen solution from the product vial.
Slovenian: Iz viale vzemite 1,0 ml raztopine zdravila Thyrogen.
English: Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Slovenian: Vial s tujki, motno ali obarvano raztopino ne uporabljajte.
English: The use of Thyrogen allows for radioiodine imaging while patients are euthyroid on thyroid hormone suppression treatment.
Slovenian: Uporaba zdravila Thyrogen dovoljuje scintigrafijo z radioaktivnim jodom pri bolnikih, ki so med potekom zdravljenja s hormonsko supresivno terapijo v evtirotičnem stanju.
English: Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue.
Slovenian: Zato je treba pri bolnikih z veliko količino preostalega tiroidnega tkiva skrbno individualno oceniti razmerje med koristmi in tveganjem.
English: The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Slovenian: Priporočeno odmerjanje zdravila Thyrogen sta dva odmerka po 0,9 mg tirotropina alfa, dana v obliki intramuskularne injekcije v razmiku 24 ur.
English: <PC: SN:
Slovenian: SN:
English: Thyrogen 0.9 mg powder for solution for injection
Slovenian: IME ZDRAVILA Thyrogen 0,9 mg prašek za raztopino za injiciranje
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Odtegnitev ščitničnih hormonov (OŠH)
English: Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
Slovenian: Po dajanju zdravila Thyrogen so poročali tudi o edemu grla, respiratornem distresu, zaradi katere je bila potrebna traheotomija, in bolečini na mestu metastaz.
English: Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala zdravila Thyrogen vsebuje nominalno vrednost 0,9 mg tirotropina alfa.
English: Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues.
Slovenian: Farmakoterapevtska skupina: Hipofizni in hipotalamični hormoni ter sorodne učinkovine, hormoni prednjega režnja hipofize in sorodne učinkovine, oznaka ATC za tirotropin alfa: H01AB01
English: For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases.
Slovenian: Pri bolnikih z metastazami CŽS je na primer prišlo do hemiplegije, hemipareze ali izgube vida.
English: Add 1.2 ml water for injection to the Thyrogen powder in the vial.
Slovenian: Prašku zdravila Thyrogen v viali dodajte 1,2 ml vode za injekcije.
English: neoplasm swelling, metastatic pain
Slovenian: otekanje neoplazme, bolečine na mestih metastaz
English: Thyrogen in combination with diagnostic radioiodine whole body scintigraphy is contra-indicated in pregnancy (see section 4.3), because of the consequent exposure of the foetus to a high dose of radioactive material.
Slovenian: Zaradi posledičnega izpostavljanja ploda visokemu odmerku radioaktivne snovi je zdravilo Thyrogen v kombinaciji s scintigrafijo celotnega telesa z radioaktivnim jodom med nosečnostjo kontraindicirano (glejte poglavje 4.3).
English: ESTIMABL1 study recurrence rates in patients who received low or high dose RAI and those who prepared with Thyrogen or THW
Slovenian: Deleži ponovitev pri bolnikih, ki so prejeli nizek ali visok odmerek radioaktivnega joda (RAI), in bolnikih, pripravljenih z zdravilom Thyrogen ali odtegnitvijo ščitničnih hormonov (OŠH), v študiji ESTIMABL1
English: I, Thyrogen + 100 mCi
Slovenian: , Thyrogen +
English: Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen.
Slovenian: Po zdravljenju z zdravilom Thyrogen se lahko pojavi zvečanje preostalega tiroidnega tkiva ali metastaz.
English: Uncommon (may affect up to 1 in 100 people): • feeling hot
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration.
Slovenian: Raztopino zdravila Thyrogen vizualno preglejte in se prepričajte, da v njej ni tujkov in da ni obarvana.
English: This may lead to acute symptoms, which depend on the anatomical location of the tissue e.g. hemiplegia, hemiparesis, loss of vision have occurred in patients with CNS metastases.
Slovenian: Pri bolnikih z metastazami CŽS je npr. prišlo do hemiplegije, hemipareze, izgube vida.
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.
Slovenian: Pri uvajanju 0,9 mg zdravila Thyrogen pri bolnikih z delno odstranjeno ali celotno ščitnico so bili poročani zelo redki primeri hipertiroidizma ali atrijske fibrilacije.
English: For radioiodine imaging or ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection.
Slovenian: Za scintigrafijo z radioaktivnim jodom ali ablacijo damo radioaktivni jod bolniku 24 ur po zadnjem injiciranju zdravila Thyrogen.
English: Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings.
Slovenian: Tako v kliničnih študijah kot tudi pri izkušnjah v obdobju trženja so poročali o občasnih pojavih preobčutljivosti.
English: It is not recommended to perform TSH assays after Thyrogen administration.
Slovenian: Po aplikaciji zdravila Thyrogen je priporočljivo opraviti določanje TSH.
English: How to store Thyrogen
Slovenian: Shranjevanje zdravila Thyrogen
English: Thyrogen Thyroid Hormone Withdrawal (THW)
Slovenian: ali odstranitev tiroidnega hormona +
English: Skin and subcutaneous tissue disorders urticaria, rash pruritus, hyperhidrosis
Slovenian: Bolezni kože in podkožja utikarija, izpuščaj pruritus, čezmerno znojenje
English: • itching (pruritus)
Slovenian: • koprivnica (urtikarija)
English: • diarrhoea
Slovenian: • oteklost tumorja
English: 1 vial of powder for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 viala praška za raztopino za injiciranje
English: • tremor
Slovenian: • bruhanje
English: The major elimination route of thyrotropin alfa is believed to be renal and to a lesser extent hepatic.
Slovenian: Predpostavljeno je, da se je tirotropin izločal v glavnem skozi ledvice in v majhni količini tudi skozi jetra.
English: Sanofi S.p.A. Tel: +800536389
Slovenian: Tel: 800536389
English: MARKETING AUTHORISATION NUMBERS
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left.
Slovenian: Če je ostalo še nekaj ščitničnega tkiva, stimulira tudi tvorbo tiroglobulina in ščitničnih hormonov.
English: Fertility
Slovenian: Thyrogen