natgillin/translations-raw huggingface dataset:
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.
Prisotnost avtoprotiteles Tg lahko pričakujemo pri 18- 40% bolnikov z diferenciranim rakom ščitnice, to pa lahko povzroči napačne negativne meritve koncentracije Tg v serumu.
3 Effect on tumour growth and/ or size:
3 Učinek na rast tumorja in/ ali njegovo velikost:
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 thyroid stimulating hormone (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 koncentracije ščitnico stimulirajočega hormona (TSH).
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth.
Obstaja teoretična možnost, da Thyrogen, tako kot odstranitev tiroidnega hormona, povzroči stimulirano rast tumorjev.
In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Vsekakor pa je bolj verjetno, da so vse spremembe velikosti tumorjev, ki naj bi jih videli, posledica edematoznih in hemoragičnih sprememb.
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 koncentracije TSH po dajanju zdravila Thyrogen bolniki z rakom ščitnice z metastazami, še posebno v omejenih prostorih kot so možgani ali hrbtenjača ali infiltracija vratu, lahko dobijo lokalne edeme ali fokalne krvavitve na mestu teh metastaz, kar poveča velikost tumorja.
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.
Pri bolnikih z metastazami CŽS je na primer prišlo do hemiplegije, hemipareze, izgube vida.
It is recommended that pretreatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.
Pri bolnikih, pri katerih lahko lokalno širjenje tumorja ogroža vitalne anatomske strukture, je priporočljivo razmisliti o predhodnem zdravljenju s kortikosteroidi.
The use of Thyrogen allows for radioiodine imaging while patients are euthyroid on thyroid hormone suppression treatment.
Uporaba zdravila Thyrogen dovoljuje scintigrafijo z radioaktivnim jodom pri bolnikih, ki so med potekom zdravljenja s supresijo tiroidnih hormonov v evtirotičnem stanju.
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.
Podatki o kinetiki radioaktivnega joda kažejo, da je pri zmanjšanem ledvičnem delovanju očistek radioaktivnega joda v evtirotičnem stanju približno 50% večji kot v hipotirotičnem stanju, kar vodi k zmanjšanemu zadrževanju radioaktivnega joda v telesu v času scintigrafije.
This factor should be considered when selecting the activity of radioiodine for use in radioiodine imaging although only a 3.7 GBq 131I activity have been tested in the trial of the pre-therapeutic stimulation.
Ta dejavnik je potrebno upoštevati pri določanju aktivnosti radioaktivnega joda za uporabo pri scintigrafiji z radioaktivnim jodom, čeprav je bila preskušana samo aktivnost 3. 7 GBq 131I pri preskusu predterapevtske uporabe.
Animal reproduction studies have not been conducted with Thyrogen.
Študije reprodukcije z zdravilom Thyrogen na živalih niso bile opravljene.
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 Thyrogen, ki ga dobi nosečnica, lahko škoduje plodu in ali lahko vpliva na zmožnost razmnoževanja.
Thyrogen in combination with diagnostic radioiodine whole body scintigraphy is contra-indicated in pregnancy, because of the consequent exposure of the foetus to a high dose of radioactive material.
Zaradi posledičnega izpostavljanja ploda visokemu odmerku radioaktivne snovi je Thyrogen v kombinaciji s scintigrafijo celotnega telesa z radioaktivnim jodiom med nosečnostjo kontraindiciran.
Patients should not breast-feed.
Bolnice ne smejo dojiti.
The most commonly reported undesirable effects are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
Neželena učinka, o katerih se največkrat poroča, sta navzea in glavobol, ki se pojavita pri približno 11% oziroma 6% bolnikov.
4 The undesirable effects mentioned in the first table, were those considered related to treatment with Thyrogen and occurring in ≥ 1/ 1,000 patients in three prospective clinical trials (N=442).
V treh kliničnih preskušanjih (N=442) so bili poročani sledeči neželeni učinki, omenjeni v prvi tabeli, tisti, za katere se smatra, da so povezani z zdravljenjem z zdravilom Thyrogen in so se pojavili najbolj pogosto pri ≥1/ 1, 000 bolnikov.
The second table includes undesirable effects that have been reported to Genzyme after licensure of Thyrogen.
Druga tabela vključuje neželene učinke o katerih so poročali Genzymu po odobritvi dovoljenja za promet za Thyrogen.
The tables are followed by a description of certain other additional effects.
Tabelam sledijo opisi določenih drugih dodatnih neželenih učinkov.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V posamezni skupini pogostosti so neželeni učinki navedeni po vrstnem redu upadanja resnosti.
System Organ Class Gastrointestinal disorders
Sistem klasifikacije organov Bolezni prebavil
Subject Incidence Very common (> 1/ 10):
Pogostost Zelo pogosto (> 1/ 10):
Common (> 1/ 100 to ≤ 1/ 10):
Pogosto (> 1/ 100 do ≤1/ 10):
Adverse Drug Reaction Nausea Vomiting
Neželeni učinek zdravila Navzea Bruhanje
Uncommon (> 1/ 1,000 to ≤ 1/ 100):
Občasno (> 1/ 1, 000 do ≤ 1/ 100):
Fatigue Influenza-like illness, Asthenia, Pyrexia, Rigors, Back pain
Utrujenost Influenci podobna bolezen, splošna oslabelost, pireksija, mrzlica, bolečine v hrbtu
Uncommon (> 1/ 1,000 to ≤ 1/ 100):
Vrtoglavica, glavobol
Dizziness Headache Paraesthesia
Občasno (> 1/ 1, 000 do ≤1/ 100):
Skin and subcutaneous tissue disorders
Parestezija Bolezni kože in podkožja Žilne bolezni
Uncommon (> 1/ 1,000 to ≤ 1/ 100):
Urtikarija, izpuščaj, Občasno (> 1/ 1, 000 do ≤ 1/ 100):
Feeling hot
Vroč občutek
The following list of undesirable effects, considered related to treatment with Thyrogen have been reported in post-marketing experience:
V postmarketinških izkušnjah so poročali o sledečem seznamu neželenih učinkov, za katere menijo, da so povezani z zdravljenjem z zdravilom Thyrogen:
System Organ Class Cardiac disorders Gastrointestinal disorders General disorders and administration site conditions
Sistem klasifikacije organov Srčne bolezni Bolezni prebavil Splošne težave in spremembe na mestu aplikacije
Rare (> 1/ 10,000 to ≤ 1/ 1,000):
Pogostost Zelo redko (≤1/ 10, 000) Redko (> 1/ 10, 000 do ≤1/ 1, 000):
Very rare (≤ 1/ 10,000):
Zelo redko (≤1/ 10, 000):
Adverse Drug Reaction Palpitations Vomiting, Nausea, Diarrhoea Influenza-like illness, Asthenia, Pyrexia, Rigors, Pain, Fatigue,
Neželeni učinek zdravila Palpitacije Slabost, bruhanje, diareja Influenci podobna bolezen, splošna oslabelost, pireksija, mrzlica, bolečina, utrujenost.
Investigations Musculoskeletal and connective tissue disorders
Preiskave Bolezni mišično- skeletnega sistema in vezivnega tkiva
Very rare (≤ 1/ 10,000):
Zelo redko (≤ 1/ 10, 000):
TSH decreased Arthralgia, Myalgia
TSH znižan Artralgija, mialgija
Neoplasm swelling, Metastatic pain
Otekanje neoplazme, bolečine na mestu metastaz,
Rare (> 1/ 10,000 to ≤ 1/ 1,000):
Redko (> 10, 000 do ≤ 1/ 1, 000):
Dizziness Headache Tremor
Vrtoglavica, glavobol Tremor
Urticaria, Rash, Pruritis, Hyperhydrosis,
Urtikarija, izpuščaj, pruritis, hiperhidroza,,
Very rare manifestations of undesirable effects related to the route of administration were reported, including discomfort, pain, pruritis, rash and urticaria at the site of intramuscular injection.
5 Poročani so bili zelo redki pojavi neželenih učinkov povezanih z načinom uporabe, kot so neugodje, bolečina, pruritis, izpuščaji in urtikarija na mestu dajanja intramuskularne injekcije.
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.
Pri uvajanju 0, 9 mg Thyrogena pri bolnikih z delno ali celotno ščitnico so bili poročani zelo redki primeri hipertiroidizma ali atrijske fibrilacije
5 Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings.
Tako v kliničnih študijah kot tudi v postmarketinških izkušnjah so poročali o občasnih pojavih preobčutljivosti.
These reactions consisted of urticaria, rash, pruritis, flushing and respiratory signs and symptoms.
Med te pojave spadajo urtikarija, izpuščaji, pruritis, rdečenje ter respiratorni znaki in simptomi.
In clinical trials involving 442 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 vključevala 442 bolnikov, ni nobeden izmed bolnikov, niti po enkratni niti po večkratni omejeni (27 bolnikov) uporabi zdravila razvil protiteles proti tirotropinu alfa.
The occurrence of antibodies which could interfere with endogenous TSH assays cannot be excluded.
Pojava protiteles, ki bi lahko motila določanje endogenenega TSH, ne moremo izključiti.
Three patients in clinical trials, and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended.
4. 9 Preveliko odmerjanje
Two patients had nausea after 2.7 mg IM dose, and in one of these patients, the event was also accompanied by weakness, dizziness and headache.
Podatki o izpostavljenosti večjemu odmerku, kot je priporočen, so omejeni na klinično preskušanje in poseben program zdravljenja.
The third patient experienced nausea, vomiting and hot flushes after 3.6 mg IM dose.
Pri dveh bolnikih se je po prejemu intramuskularnega odmerka 2, 7 mg pojavila slabost in pri enem od teh bolnikov se je v zvezi s tem pojavila še šibkost, omotičnost in glavobol.
In the special treatment program, a 77 year-old patient with metastatic thyroid cancer who had not been thyroidectomized 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- tih dneh prejel 4 odmerke zdravila Thyrogen 0, 9 mg.
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.
Pri tem bolniku, ki je dobil enkraten intravenski odmerek 0, 3 mg, so se po 15 minutah pojavili naslednji neželeni učinki: slabost, bruhanje, čezmerno znojenje, hipotenzija in tahikardija.
Anterior Pituitary Lobe Hormones and Analogues, ATC code:
Hormoni prednjega režnja hipofize in sorodne učinkovine, oznaka ATC:
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.
Sestavljen je iz dveh med sabo nekovalentno povezanih podenot. cDNA kodira za alfa podenoto iz 92 aminokislinskih ostankov z dvema N- glikozilacijskima mestoma in za beta podenoto iz 118 ostankov in z enim N- glikozilacijskim mestom.
It has comparable biochemical properties to natural human Thyroid Stimulating Hormone (TSH).
Tirotropin alfa ima biokemijske značilnosti, primerljive z naravnim človeškim ščitnico stimulirajočim hormonom (TSH).
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 koncentracijo TSH- ja v serumu, da stimulira privzem radioaktivnega joda ali izločanje tiroglobulina.
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.
Standardni pristop za zvišanje koncentracije TSH- ja je prenehanje z zdravljenjem s supresijo tiroidnih hormonov (THST) pri bolnikih, pri katerih ponavadi povzroči znake ali simptome hipotireodizma.
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- ja, potrebno za privzem radioaktivnega joda in/ ali izločanje tiroglobulina medtem, ko so bolniki evtirotični med zdravljenjem s THST in se tako izognemo morbidnosti, povezani z hipotirozo.
6 Diagnostic use 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.
Diagnostična uporaba Učinkovitost in varnost zdravila Thyrogen za uporabo scintigrafije z radioaktivnim jodnom skupaj z določanjem tiroglobulina v serumu za diagnozo tiroidnih ostankov in raka sta bili predstavljeni v dveh študijah.
In one of the studies, two dose regimens were examined:
V eni izmed študij so preverili dve shemi odmerjanja:
0.9 mg intramuscular every 24 hours for two doses (0.9 mg x 2) and 0.9 mg intramuscular every 72 hours for three doses (0.9 mg x 3).
0, 9 mg intramuskularnega vsakih 24 ur za dva odmerka (0, 9 mgx2) in 0, 9 mg intramuskularnega vsakih 72 ur za tri odmerke (0, 9 mgx3).
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 zvišanja radioaktivnega joda za diagnostično scintigrafijo.
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.
Obe shemi odmerjanja sta v primerjavi s testi, opravljenimi, ko so bolniki dobivali tiroidne hormone, izboljšali občutljivost, natančnost in negativno napovedovalno vrednost tiroglobulina, stimuliranega z zdravilom Thyrogen, samega ali v kombinaciji scintigrafije z radioaktivnim jodnom.
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.
Pri tem so z zdravilom Thyrogen stimulirane ravni tireoglobulina, 3 ng/ ml, 2 ng/ ml in 1 ng/ ml, ustrezale ravnem tireoglobulina po odstranitvi tiroidnih hormonov, ki so znašale 10 ng/ ml, 5 ng/ ml in 2 ng/ ml.
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 tireoglobulinski testi z zdravilom Thyrogen izkazali za občutljivejše od tistih s THST.
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.
Še posebej je bil pri študiji v tretji fazi s 164 bolniki odstotek odkritja tkiva ščitnice po tireoglobulinskem testu z zdravilom Thyrogen med 73- 87%, medtem ko je ta vrednost pri istih mejnih vrednostih in primerljivih referenčnih standardih pri tireoglobulinskih preskusih s THST znašala med 42- 62%.
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 odkrili pri 35 bolnikih.
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.
Koncentracije tiroglobulina, stimulirane s strani zdravila Thyrogen, so bile nad 2 ng/ ml pri vseh 35 bolnikih, medtem ko je tiroglobulin pri THST bil nad 2 ng/ ml pri 79% teh bolnikov.
Pre-therapeutic stimulation In a comparator study involving 60 evaluable low risk patients, the rates of successful ablation of thyroid remnants with 100 mCi radioiodine in post-thyroidectomy patients with thyroid cancer, were comparable for patients treated after withdrawal of THST versus patients treated after Thyrogen administration.
7 Predterapevtska stimulacija V primerjalni raziskavi z 60 bolniki z nizkim tveganjem se je stopnja uspešnih ablacij tiroidnih ostankov z 100 mCi radioaktivnega joda pri bolnikih po tiroidektomiji z rakom ščitnice lahko primerjala pri bolnikih, zdravljenih po prekinitvi THST, in bolnikih, zdravljenih po uvajanju Thyrogena.
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, NO-N1, MO (TNM classification).
V študijo vključeni bolniki so bili odrasli (> 18 let), pri katerih je bil pred kratkim diagnosticiran diferencirani papilarni ali folikularni karcinom ščitnice, vključno s papilarnofolikularno varianto, označen predvsem (54 od 60) kot T1- T2, NO- N1, MO (TNM klasifikacija).
Success of remnant ablation was assessed with radioiodine imaging and with serum thyroglobulin testing at 8 months after treatment.
Uspešnost ablacije ostankov se je ocenjevala s scintigrafijo z radioaktivnim jodnom in z določanjem tiroglobulina v serumu 8 mesecev po zdravljenju.
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 uvajanju Thyrogena, ni kazalo vidnega privzemanja radioaktivnega joda ali je kazalo < 0. 1% privzemanja uvedene aktivnosti radioaktivnega joda.
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 stopnje Tg Thyrogenstimuliranega seruma < 2 ng/ ml osem mesecev po ablaciji, a le pri bolnikih, negativnih na anti- Tg protitelesa.
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 18/ 21 bolnikov (86%) in 23/ 24 bolnikov (96%) kazalo znake uspešne ablacije tiroidnih ostankov v skupini s prekinitvijo THST in skupini z uvajanjem Thyrogena.
There is evidence from the literature of lower efficacy of Thyrogen administration compared with withdrawal of THST when using 30 mCi.
V literaturi ni dokazov za manjšo učinkovitost uporabe zdravila Thyrogen v primerjavi s prenehanjem TSHT, pri uporabi 30 mCi.
Therefore, efficacy of Thyrogen with doses of 131I < 100 mCi has not been established.
Zaradi tega učinkovitost zdravila Thyrogen z odmerki 131I < 100 mCi ni bila dokazana.
Quality of life was significantly reduced following thyroid hormone withdrawal, but maintained following either dosage regimen of Thyrogen in both indications.
Po odstranitvi tiroidnega hormona se je kakovost življenja vidno poslabšala, pri odmerjanju tirotropina alfa pa je ostala stabilna pri obeh indikacijah.
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.
After injection, the mean peak (C max) level obtained was 116 ± 38 mU/ l and occurred approximately 13 ± 8 hours after administration.
Po injiciranju je znašala povprečna največja vrednost (C max) 116 ± 38 milienot/ l in se je pojavila približno 13±8ur po injekciji.
The elimination half-life was 22 ± 9 hours.
Razpolovni čas je bil 22 ±9 ur.
Non-clinical data are limited, but reveal no special hazard to man from use of Thyrogen.
Majhna količina nekliničnih podatkov ni razkrila posebnega tveganja o uporabi zdravila Thyrogen pri človeku.
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride
manitol natrijev dihidrogenfosfat mohohidrat natrijev hidrogenfosfat heptahidrat natrijev klorid
In the absence of compatibility studies, Thyrogen should not be administered as a mixture with other medicinal products in the same injection.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Shelf-life after reconstitution It is recommended that the Thyrogen solution be injected within three hours.
Neodprte viale 3 leta Rok uporabnosti po rekonstituciji Priporočeno je, da raztopino zdravila Thyrogen injicirate v treh urah.
The reconstituted solution can be stored for up to 24 hours at a temperature at 2°C - 8°C under protection from light, while avoiding microbial contamination.
Rekonstituirano raztopino lahko hranite do 24 ur pri temperaturi med 2°C in 8°C, zaščiteno pred svetlobo.
6.4 Special precautions for storage
Pri tem je potrebno preprečiti mikrobno kontaminacijo.
Store in a refrigerator (2°C - 8°C).
6. 4 Posebna navodila za shranjevanje
Keep the vial in the outer carton in order to protect from light.
Shranjujte v hladilniku (2 °C - 8 °C) Vialo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
Clear Type I glass 5 ml vials.
Prozorne 5 ml viale iz stekla tipa I.
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Zapiralo je sestavljeno iz silikoniziranega butilnega snemljivega pokrovčka, ki je varen pred odpiranjem.
Each vial contains 1.1 mg thyrotropin alfa.
Vsaka viala zdravila Thyrogen vsebuje 1, 1 mg tirotropina alfa.
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) injicira bolniku.
To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Da bi vsakič bilo na voljo dovolj prostornine za natančen odmerek, vsebuje vsaka viala zdravila Thyrogen 0, 2 ml presežka.
Package size: one and two vials of Thyrogen per carton
Velikost pakiranja: ena ali dve viali zdravila Thyrogen na škatlico.
Only one vial of Thyrogen is required per injection.
Na injekcijo je potrebna samo ena viala zdravila Thyrogen.
Use Aseptic Technique
Uporaba aseptične tehnike