natgillin/translations-raw huggingface dataset:
Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
Popravak pojedinačnog simptomatičnog oštećenja hrskavice femoralnog kondila koljena (stupnja III
Although it is thought that these reactions are mostly surgery-related, a potential influence of the expanded chondrocytes cannot be completely excluded.
Iako se smatra da su te reakcije uglavnom povezane s kirurškim postupkom,
Concomitant knee problems like early osteoarthritis, osteochondritis dissecans (OCD), instability of the knee, cartilage lesions at other locations than the femoral condyle, lesions of knee ligaments or of the meniscus, varus or valgus malalignment (abnormal weight distribution in the knee), and inflammatory joint disease are potential complicating factors.
Česti problemi s koljenom kao što su rani osteoartritis, disekantni osteohondritis (eng. osteochondritis dissecans, OCD), nestabilnost koljena, lezije hrskavice koje se javljaju na drugim mjestima osim na femoralnom kondilu, lezije ligamenata koljena ili meniskusa, varusna ili valgusna deformacija
However, the concomitant use of another type of fibrin glue with a synthetic fibrinolysis inhibitor (tranexamic acid) in the pivotal clinical trial did not reveal any safety signal.
Ipak, upotreba druge vrste fibrinskog ljepila sa sintetičkim inhibitorom fibrinolize
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1, 2 or 3 vials x 0.4 ml
1, 2 ili 3 bočice x 0,4 ml
Description of selected adverse reactions
Opis odabranih nuspojava Artrofibroza
Uncommon side effects (affects in 1 to 10 users in 1,000 include: anxiety, dermal and visual hypersensitivity ), migraine, mini stroke (transient ischaemic attack), fat entering the circulatory system (fat embolism), vein blockage and inflammation (thrombophlebitis), blockage in a lung artery (lung embolism), itching scar, pain at the front of the knee (chondromalacia), breakdown of knee tissue (gonartrhosis, atrophy), discomfort, chronic inflammation (granulomatous lesion).
Manje česte nuspojave (pojavljuju se kod 1 do 10 korisnika od 1 000) uključuju: tjeskoba, kožna i vizualna preosjetljivost, migrena, mali moždani udar (tranzitorna ishemijska ataka), mast koja ulazi u cirkulacijski sustav (masna embolija), blokada i upala vena (tromboflebitis), blokada plućne arterije
Re-intervention on the treated lesion for graft delamination or periost loosening occurred in 2 of 51 patients within 36 months after ChondroCelect implantation, compared to 7 of 61 patients treated with microfracture having generally insufficient or inadequate cartilage repair.
Do ponovnog zahvata na mjestu lezije zbog delaminacije presatka ili labavljenja pokosnice došlo je kod 2 od 51 bolesnika u roku od 36 mjeseci nakon implantacije lijeka
Impaired healing, Implant site hypersensitivity, Peripheral edema, Pyrexia
slabo zacjeljivanje, preosjetljivost mjesta implantacije, periferalni edem, pireksija atrofija, nelagoda, granulomatozna lezija
In the subgroup of patients with recent symptom onset (< 3 years) the clinical benefit of ChondroCelect over microfracture was significantly larger, confirming the results at 36 months after treatment.
U podskupini bolesnika s nedavnom pojavom simptoma (<3 godine) klinička korist liječenjem lijekom
Tabulated list of adverse reactions They are listed by System Organ Class and frequency.
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
Psychiatric disorders
Psihijatrijski poremećaji tjeskoba
• The schedule of follow-up of patients
• Farmakovigilancijski sustav
Hyperesthesia, Migraine,
atrofija mišića,
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) of the biological active substance(s) PharmaCell Cell Manufacturing Facility B.V.
Naziv i adresa proizvođača biološke(ih) djelatne(ih) tvari
Deep vein thrombosis, Haematoma, Superficial phlebitis
Krvožilni poremećaji duboka venska tromboza, hematom, površinski flebitis masna embolija, tromboflebitis
- If you get any of the side effects, talk to your doctor, surgeon or physical therapist.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, kirurga ili fizioterapeuta.
Cartilage hypertrophy
Hipertrofija hrskavice
Treatment with ChondroCelect: a two-step procedure.
Liječenje lijekom ChondroCelect: postupak u dvije faze 1. posjet: procjena oštećenja hrskavice i biopsija
Complete joint haemostasis must be achieved prior to membrane fixation and cell implantation.
Prije učvršćenja membrane i implantacije stanica treba se postići potpuna hemostaza zgloba.
As ChondroCelect is used to repair a cartilage defect of the knee and is implanted with the ACI procedure using open-knee surgery, it is not recommended during pregnancy.
Budući da se ChondroCelect koristi za popravak oštećenja hrskavice i implantira primjenom ACI
What ChondroCelect looks like and contents of the pack ChondroCelect is a cell suspension (a fluid) for implantation.
ChondroCelect je stanična suspenzija (tekućina) implantata.
Nervous system disorders
Poremećaji probavnog sustava mučnina
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja apneja plućna embolija
Very common side effects (affects more than 1 user in 10) include: joint pain (arthralgia), overgrowth of cartilage cells (cartilage hypertrophy), crackling or clicking sensation when articulating the knee (joint crepitation), and joint swelling.
(artralgija), prekomjerni rast stanica hrskavice (hipertrofija hrskavice), osjećaj pucketanja ili škljocanja kada se savija koljeno (krepitacija zgloba) i naticanje zgloba.
Arthroscopy
• artralgija
You can recognize most of the joint- related side effects if you have symptoms like pain, snapping, grinding, locking, swelling, bending limitations and stiffness in the knee.
Većinu nuspojava vezanih uz zglobove možete prepoznati ako imate simptome kao što su bol,
Photophobia, Transient ischaemic attack
Trendelenburgov simptom hiperestezija, migrena, fotofobija, tranzitorna ishemijska ataka
If you get any side effects, talk to your doctor or physical therapist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili fizioterapeuta.
Implantation suspension.
OBLIK I SADRŽAJ Suspenzija implantata.
Gastrointestinal disorders
Pretrage artroskopija
Visit 1: evaluation of the cartilage defect and biopsy On the first visit, the surgeon will evaluate your cartilage defect during an exploratory operation (arthroscopy).
Prilikom prvog posjeta kirurg će procijeniti oštećenje
Scar pain,
poremećaj tetive,
Arthritis,
(artroskopije).
Ineffective therapeutic product,
UČINKOVITU PRIMJENU LIJEKA
Hypertrophic scar, Postoperative wound complication, Pruritus,
Trendelenburgov znak), degenerativni poremećaj zgloba (osteoartritis), poremećaj tetiva, upala tetive
Given the local nature of ChondroCelect adverse reactions on the nursing infant are not anticipated.
ChondroCelecta, ne očekuju se nuspojave na dijete koje se doji.
Skin and subcutaneous tissue disorders
Mogu se pojaviti popratne asimptomatične lezije hrskavice
Haemarthrosis, Joint instability, Joint stiffness, Loose body in joint, Mobility decreased, Muscle atrophy, Osteoarthritis, Synovial cyst, Synovitis,
Poremećaji mišićno koštanog sustava i vezivnog tkiva artrofibroza, smanjen opseg pokretljivosti zgloba, zglobni izljev, blokada zgloba, artritis, artropatija, cista kosti, oticanje kosti, burzitis, hondropatija, egzostoza, hemartroza, nestabilnost zgloba, krutost zgloba, slobodno tijelo u zglobu, smanjena pokretljivost,
Apnoea
OBLIK
Atrophy,
Dulbecco's
In addition, no patient had a definitive recurrence during the 3.7 years of follow-up.
Nadalje, nijedan bolesnik nije imao definitivan povrat bolesti tijekom 3,7 godina praćenja.
These hormones can be measured in your blood.
Razina ovih hormona može se mjeriti u krvi.
It is comprised of two non-covalently linked subunits.
Sastoji se od dvije nekovalentno povezane podjedinice.
In clinical trials this was not seen.
To nije primijećeno u kliničkim ispitivanjima.
This may lead to increased risk of headache and nausea.
To može dovesti do povećanog rizika od glavobolje i mučnine.
It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Važno je napomenuti da mikrobiološka sigurnost otopine ovisi o aseptičkim uvjetima tijekom njezine pripreme.
The elimination halflife was 22 ± 9 hours.
Poluvrijeme eliminacije iznosilo je 22 ± 9 sati.
Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
Datum posljednje obnove odobrenja: 9.ožujka 2010.
No special precautions for elderly patients are necessary.
Nisu potrebne posebne mjere opreza u starijih osoba.
Use aseptic technique.
Primijenite aseptičku tehniku.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The median follow-up was 6.5 years (4.5 to 7.6 years).
Medijan razdoblja praćenja je bio 6,5 godina (4,5 do 7,6 godina).
45, 51, 68, 74, 76 and 80 New York Avenue Framingham, MA 01701
45, 51, 55, 68, 74, 76 and 80 New York Avenue Framingham,
The median follow-up was 5.4 years (0.5 to 9.2 years).
Medijan razdoblja praćenja je bio 5,4 godine (0,5 do 9,2 godine).
The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively.
Najčešće prijavljene nuspojave su mučnina i glavobolja, koje se javljaju u približno 11%, odnosno 6%
Infections and infestations influenza
Infekcije i infestacije gripa
Therefore, both TgAb and Tg assays are needed.
Stoga je potrebno odrediti i TgAb i Tg.
No dose adjustment is necessary in elderly (see section 4.4).
Nije potrebno prilagođavati dozu u starijih osoba (vidjeti dio 4.4).
• pain (including pain at the site of metastases (secondary cancer growths))
• bol (uključujući bol na mjestu metastaza (sekundarni rast karcinoma))
Do not take Thyrogen if you are pregnant.
Ne smijete primati Thyrogen ako ste trudni.
Your child's doctor will help you decide if Thyrogen should be given to your child.
Liječnik Vašeg djeteta pomoći će Vam odlučiti treba li Vašem djetetu davati Thyrogen.
Your doctor will decide if you belong to a specific group of patients for which pre-treatment with corticosteroids is to be considered (for example, if you have secondary cancer growths in your brain or spinal cord).
Vaš će liječnik odrediti pripadate li skupini bolesnika za koje treba razmotriti prethodno liječenje kortikosteroidima (primjerice, ako imate sekundarni rast karcinoma u mozgu ili kralježničnoj moždini).
Total number of patients with recurrence
Ukupan broj bolesnika s povratom bolesti
This solution should never be injected into a vein.
Ova otopina nikada se ne smije injicirati u venu.
• if you have reduced liver function; you should still be able to receive Thyrogen.
• ako imate oslabljenu funkciju jetre; svejedno biste trebali moći primati Thyrogen.
Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „EXP”.
Administration within 3 hours after reconstitution.
Primijeniti u roku od 3 sata nakon pripreme.
Post-treatment scanning may be delayed a few days to allow background radioactivity to decline.
Snimanje nakon liječenja može se odgoditi nekoliko dana kako bi se smanjila pozadinska radioaktivnost.
Thyrogen contains sodium, see section 2.
Thyrogen sadrži natrij, pogledajte dio 2.
Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.
Podaci o izlaganju dozama većima od preporučenih ograničeni su na podatke iz kliničkih ispitivanja i posebnog programa liječenja.
Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes.
Rezultati kontroliranih ispitivanja ukazuju na to da se sigurnost i djelotvornost lijeka Thyrogen ne razlikuju u odraslih bolesnika mlađih od 65 godina i onih starijih od 65 godina kada se Thyrogen primjenjuje u dijagnostičke svrhe.
For the ESTIMABL1 study, 726 (97%) of the original 752 patients were followed up for disease recurrence.
U ispitivanju ESTIMABL1, u 726 (97%) od 752 početna bolesnika bio je praćen povrat bolesti.
Non-clinical data are limited, but reveal no special hazard for humans from use of Thyrogen.
Neklinički podaci su ograničeni, no ne ukazuju na poseban rizik primjene lijeka Thyrogen za ljude.
Pre-therapeutic stimulation
Predterapijska stimulacija
In the absence of compatibility studies, this medicinal product must not be administered as a mixture with other medicinal products in the same injection.
Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima u istoj injekciji.
• if you are allergic to bovine or human thyroid stimulating hormone (TSH) or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na goveđi ili ljudski hormon koji stimulira štitnjaču (TSH) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
All 95% confidence intervals for the differences were within ±10 percentage points, indicating in particular non-inferiority of the low to the high radioiodineactivity.
Svi 95%-tni intervali pouzdanosti za razlike kretali su se unutar ±10 postotnih bodova, što naročito ukazuje na neinferiornost niske u odnosu na visoku aktivnost radioaktivnog joda.
What Thyrogen is and what it is used for
Što je Thyrogen i za što se koristi
However if your thyroid gland has not been removed completely and you are also suffering from heart disease, your doctor will help you decide if Thyrogen should be given to you.
Međutim, ako Vam štitna žlijezda nije u potpunosti uklonjena i ujedno bolujete od srčane bolesti, liječnik će Vam pomoći odlučiti trebate li primati Thyrogen.
Thyrogen (N=374) THW (N=378)
Thyrogen (N=374)
Swirl the contents of the vial gently until all material is dissolved.
Lagano kružno miješajte sadržaj bočice dok se sav prašak ne otopi.
Other medicines and Thyrogen Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
A follow-up study was conducted on patients who previously completed the initial study, and data is available for 51 patients.
Provedeno je praćenje bolesnika koji su prethodno završili inicijalno ispitivanje, a podaci su dostupni za
What Thyrogen looks like and contents of the pack
Kako Thyrogen izgleda i sadržaj pakiraanja
Analyses of T3 patients and N1 patients showed that these subgroups had equally good ablation success rates as did lower-risk patients.
Analize bolesnika sa stadijem bolesti T3 odnosno N1 pokazale su da su stope uspješnih ablacija u tim podskupinama bile jednako dobre kao u bolesnika nižeg rizika.
For the HiLo study, 434 (99%) of the original 438 patients were followed up for disease recurrence.
U ispitivanju HiLo, u 434 (99%) od početnih 438 bolesnika bio je praćen povrat bolesti.
The long term follow-up data in ESTIMABL1 and HiLo confirmed similar outcomes for patients in all four treatment groups.
Podaci dobiveni dugoročnim praćenjem bolesnika u ispitivanjima ESTIMABL1 i HiLo potvrdili su slične ishode liječenja za bolesnike u sve četiri skupine.
Thyrogen must not be mixed with other medicines in the same injection.
Thyrogen se ne smije miješati s drugim lijekovima u istoj injekciji.
Patients were still considered to be successfully ablated if there was no visible thyroid bed uptake on the scan, or if visible, uptake was less than 0.1%.
Ablacija se u bolesnika i dalje smatrala uspješnom ako na snimku nije bilo vidljivog nakupljanja joda u ležištu štitnjače, ili je ono, ako je bilo vidljivo, iznosilo manje od 0,1%.
Breast-feeding should only be resumed following advice from your doctor.
S dojenjem možete nastaviti tek nakon savjetovanja s liječnikom.
Very Common
Vrlo često Često
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.
U kliničkim ispitivanjima koja su uključivala 481 bolesnika nijedan bolesnik nije razvio protutijela na tireotropin alfa ni nakon jednokratne ni nakon ponovljene ograničene (27 bolesnika) primjene lijeka.
Three patients in clinical trials and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended.
Tri bolesnika u kliničkim ispitivanjima i jedan u posebnom programu liječenja imali su simptome nakon primanja doza lijeka Thyrogen većih od preporučenih.
Overall, 48/51 patients (94%) had no evidence of cancer recurrence, 1 patient had possible cancer recurrence (although it was not clear whether this patient had a true recurrence or persistent tumour from the regional disease noted at the start of the original study), and 2 patients could not be assessed.
Ukupno gledajući, u 48/51 bolesnika (94%) nije bilo dokaza povrata karcinoma, u jednog je bolesnika postojala mogućnost povrata karcinoma (iako nije bilo jasno radi li se o pravom povratu ili o perzistentnom tumoru lokalizirane bolesti zabilježene na početku inicijalnog ispitivanja), a 2 bolesnika se nije moglo ocijeniti.
Thyrogen may reduce the ability to drive or use machines, since dizziness and headaches have been reported.
Thyrogen može umanjiti sposobnost upravljanja vozilima i rada sa strojevima, s obzirom da su prijavljene omaglica i glavobolje.
• influenza
• gripa
Metastatic disease was confirmed by a post-treatment scan or by lymph node biopsy in 35 patients.
Metastatska bolest potvrđena je skeniranjem nakon liječenja ili biopsijom limfnih čvorova u 35 bolesnika.
Your doctor will determine the exact activity of radioiodine to use for radioiodine imaging, taking into consideration the fact that you continue to take thyroid hormones.
Liječnik će odrediti točnu aktivnost radioaktivnog joda potrebnu za radiojodnu scintigrafiju, uzimajući u obzir činjenicu da nastavljate s uzimanjem hormona štitnjače.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA DRUGO
This may lead to acute symptoms, which depend on the anatomical location of the tissue.
To može dovesti do pojave akutnih simptoma, koji ovise o anatomskoj lokalizaciji zahvaćenoga tkiva.
Do not use Thyrogen:
Nemojte primjenjivati Thyrogen:
Genzyme Europe B.V.- NL
Genzyme Europe B.V.-
ATC code for thyrotropin alfa: H01AB01
ATK oznaka za tireotropin alfa: H01AB01.
In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
U bolesnika sa značajnim oštećenjem bubrežne funkcije dozu radioaktivnog joda treba pažljivo odrediti liječnik specijalist nuklearne medicine.
In one of the studies, two dose regimens were examined: 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).
U jednom od njih ispitivana su dva protokola doziranja: dvije doze od 0,9 mg intramuskularno u razmaku od 24 sata (0,9 mg x 2) i tri doze od 0,9 mg intramuskularno u razmaku od 72 sata (0,9 mg x 3).
Cardiac disorders palpitations
Srčani poremećaji palpitacije
Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Zbog nedostatka podataka o primjeni lijeka Thyrogen u djece, lijek Thyrogen treba dati djeci samo u iznimnim okolnostima.
Dispose of any unused solution immediately.
Odmah zbrinuti svu neiskorištenu otopinu.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2
Thyrogen does not contain preservatives.
Thyrogen ne sadrži konzervanse.
The Thyrogen solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2°C and 8°C).
Otopina lijeka Thyrogen mora se injicirati u roku od tri sata; međutim, otopina lijeka Thyrogen će ostati kemijski stabilna do najduže 24 sata ako se čuva u hladnjaku (između 2°C i 8°C).
Effect on tumour growth and/or size
Učinak na rast i/ili veličinu tumora:
The use of Thyrogen in patients with reduced liver function does not warrant special considerations.
Primjena lijeka Thyrogen u bolesnika s oslabljenom funkcijom jetre ne zahtijeva posebno razmatranje.
• if you have kidney disease that requires dialysis and he will decide how much Thyrogen to give to you as you may have more chance of experiencing headache and nausea.
• ako imate bolest bubrega koja zahtijeva dijalizu, a liječnik će odlučiti koliko lijeka Thyrogen trebate primiti s obzirom da postoji veća vjerojatnost da dobijete glavobolju i mučninu.
There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.
Nema poznatih interakcija s lijekom Thyrogen i hormonima štitnjače koje možda uzimate.
After injection, the mean peak (Cmax) level obtained was 116 ± 38 mU/l and occurred approximately 13 ± 8 hours after administration.
Srednja vrijednost vršne koncentracije (Cmax) postignuta nakon injekcije iznosila je 116 ± 38 mU/l i nastupila je približno 13 ± 8 sati nakon primjene.
Each vial of Thyrogen is for single use only.
Svaka bočica lijeka Thyrogen namijenjena je samo za jednokratnu uporabu.
The powder for solution for injection has to be reconstituted with water for injection.
Prašak za otopinu za injekciju mora se rekonstituirati s vodom za injekcije.
Total number of patients with recurrence (5.4 years) Low activity RAI (1.1 GBq) High activity RAI (3.7 GBq)
Ukupan broj bolesnika s povratom bolesti (5,4 godine) Radioaktivni jod niske aktivnosti (1,1 GBq) Radioaktivni jod visoke aktivnosti(3,7 GBq)
It is unknown whether thyrotropin alfa /metabolites are excreted in human milk.
Nije poznato izlučuju li se tireotropin alfa/metaboliti u majčino mlijeko.
If the metastases are present in narrow spaces e.g. intracerebral (in the brain) or in the spinal cord, patients could experience symptoms which can occur quickly such as partial paralysis affecting one side of the body (hemiparesis), breathing problems or loss of vision.
Ako su se metastaze razvile u uskim prostorima, primjerice u intracerebralnom prostoru (u mozgu) ili u kralježničnoj moždini, bolesnici mogu brzo razviti simptome poput djelomične paralize jedne strane tijela (hemipareza), problema s disanjem ili gubitka vida.
• hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.
• preosjetljivost (alergijske reakcije); ove reakcije uključuju koprivnjaču (urtikariju), svrbež, navale crvenila, otežano disanje i osip.
Do not use this medicine if you notice foreign particles, cloudiness or discoloration.
Ne primjenjujte lijek ako primijetite strane čestice, zamućenje ili promjenu boje.
In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
U kliničkim ispitivanjima tireotropina alfa, koji izaziva kratkoročno povišenje razina TSH-a u serumu, nije prijavljen niti jedan slučaj rasta tumora.