natgillin/translations-raw huggingface dataset:
Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Ključni sekundarni merili učinkovitosti sta bili raziskovalčeva ocena deleža objektivnega odziva (ORR - objective response rate) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Smernice za trajno ukinitev zdravljenja ali zadržanje odmerka so navedene v preglednici 1.
• Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns:
• Relevantne podatke (npr. o resnosti, jakosti, pogostnosti, času pojava, reverzibilnosti neželenega učinka, kot je primerno) za naslednja varnostna tveganja:
The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila Nivolumab BMS pri otrocih, mlajših od 18 let, nista bili dokazani.
Because of the small sample size, no definitive conclusions can be drawn from these data.
Ti podatki zaradi majhne velikosti vzorca ne omogočajo definitivnih zaključkov.
Do not shake the vial.
Viale ne stresajte.
No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
O posebnih razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let)
Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Zdravila Nivolumab BMS se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Frequencies are defined 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).
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment.
Povprečna ocena EQ-VAS se je sčasoma povečala v obeh skupinah zdravljenja, kar kaže boljše splošno zdravstveno stanje bolnikov,
To continue the exploration of the optimal cut-off for PD-L1 positivity based on current assay method used to further elucidate its value as predictive of nivolumab efficacy.
Nadaljevati raziskave optimalne mejne vrednosti PD-L1 pozitivnosti na osnovi trenutne testne metode za dodatno ovrednotenje njene napovedne vrednosti za učinkovitost nivolumaba.
Effective contraception should be used for at least 5 months following the last dose of Nivolumab BMS.
Učinkovito kontracepcijo je treba uporabljati še vsaj 5 mesecev po zadnjem odmerku zdravila Nivolumab BMS.
The value of biomarkers to predict the efficacy of nivolumab should be further explored, specifically:
Dodatno je treba raziskati vrednost bioloških označevalcev za predvidevanje učinkovitosti nivolumaba, in sicer:
Overall survival Events
Celokupno preživetje
See “Description of selected adverse reactions; laboratory abnormalities” below.
Glejte “Opis izbranih neželenih učinkov; Laboratorijsko ugotovljene nepravilnosti” v nadaljevanju.
Results for growth indices, as well as teratogenic, neurobehavioral, immunological, and clinical pathology parameters throughout the 6-month postnatal period were comparable to the control group.
Rezultati indeksov rasti, pa tudi teratogeni, nevrovedenjski, imunološki in klinični patološki parametri so bili do 6 meseca po kotitvi primerljivi s kontrolno skupino.
Pack size of 1 vial.
Pakiranje z 1 vialo.
Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom trženja zdravila Nivolumab BMS mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načinom distribucije in vseh drugih vidikih programa.
Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Uporaba nivolumaba ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen v primeru, ko klinična korist odtehta možno tveganje.
Inflammation of the liver (hepatitis).
vnetje jeter (hepatitis).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne Navodilo shranite.
There are no data on the use of nivolumab in pregnant women.
Podatkov o uporabi nivolumaba pri nosečnicah ni.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Večina teh neželenih učinkov, vključno z resnimi, je minila po uvedbi ustreznega zdravljenja ali prekinitvi zdravljenja z nivolumabom (glejte “Opis izbranih neželenih učinkov” v nadaljevanju).
The amount of Nivolumab BMS you will be given will be calculated based on your body weight.
Količina zdravila Nivolumab BMS, ki jo boste prejeli, se izračuna na osnovi telesne mase.
The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z nivolumabom za vse podskupine pediatrične populacije pri zdravljenju malignih solidnih tumorjev (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses.
Receptor PD-1 je negativni regulator T-celične aktivnosti, za katerega je bilo dokazano, da sodeluje pri nadzoru T-celičnega imunskega odziva.
Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy.
Bolnike je treba neprestano nadzirati (še vsaj do 5 mesecev po aplikaciji zadnjega odmerka), saj se neželeni učinki nivolumaba lahko pojavijo v katerem koli času med zdravljenjem ali po ukinitvi zdravljenja z nivolumabom.
• Signs or symptoms of the safety concern and when to seek attention from a HCP
• Znake ali simptome varnostnih tveganj in navodilo, kdaj poiskati zdravniško pomoč.
Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences).
Nivolumab se pritrdi na ciljno beljakovino, imenovano receptor za programirano celično smrt-1 (PD-1), ki lahko zavre aktivnost celic T (vrsta belih krvnih celic, ki so sestavni del imunskega sistema, naravne obrambe telesa).
Be aware of important symptoms of inflammation.
Pozorni morate biti na pomembne simptome vnetja.
Grade 2 pneumonitis
Pnevmonitis stopnje 2
The Kaplan-Meier curves for OS are shown in Figure 1.
Kaplan-Meierjevi krivulji celokupnega preživetja sta prikazani na sliki 1.
Nivolumab BMS may cause changes in the results of tests carried out by your doctor.
Zdravilo Nivolumab BMS lahko povzroči spremembe v izvidih preiskav, ki jih bo opravil zdravnik.
For instructions on the handling of the medicinal product before administration, see section 6.6.
Za navodila glede ravnanja z zdravilom pred aplikacijo glejte poglavje 6.6.
Use a separate infusion line for the infusion.
Za infundiranje morate uporabiti ločeno infuzijsko linijo.
Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them.
Zaradi možnih neželenih učinkov, kot je utrujenost (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri vožnji ali upravljanju s stroji, dokler se z gotovostjo ne izkaže, da nivolumab pri njih nima škodljivih vplivov na tovrstne aktivnosti.
Treatment modification
Prilagoditev zdravljenja
Inflammation or problems with your kidneys.
vnetje ali težave z ledvicami.
The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg.
pH vrednost raztopine je približno 6,0, osmolalnost pa približno 340 mOsm/kg.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o
Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Pogostnost odraža delež bolnikov s poslabšanjem glede na izhodiščne laboratorijske izvide.
A decision must be made whether to discontinue breast-feeding or to discontinue from nivolumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z nivolumabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Nivolumab je humano monoklonsko IgG4 (imunoglobulin G4) protitelo (HuMAb), ki se veže na receptor za programirano celično smrt-1 (PD-1) in zavira njegovo interakcijo s PD-L1 in PD-L2.
The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Delež izboljšanja z boleznijo povezanih simptomov, ovrednoten po lestvici LCSS, je bil podoben med skupino z nivolumabom (18,5 %) in skupino z docetakselom (21,2 %).
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
To so lahko znaki vnetja pljuč (pljučnica ali bolezen pljučnega intersticija).
As with all therapeutic proteins, there is a potential for an immune response to nivolumab.
Kot pri drugih terapevtskih beljakovinah tudi pri uporabi nivolumaba obstaja možnost imunskega odziva na nivolumab.
The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with Nivolumab BMS use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early those adverse events.
Izobraževalni program je namenjen povečanju ozaveščenosti o možnosti pojava imunsko pogojenih neželenih učinkov pri uporabi zdravila Nivolumab BMS, kako ukrepati v primeru njihovega pojava in okrepiti ozaveščenost bolnikov ali oseb, ki zanje skrbijo, o znakih in simptomih, ki so pomembni za zgodnje odkritje teh neželenih učinkov.
Other in-use storage time and conditions are the responsibility of the user.
Za drugačen čas in pogoje shranjevanja med uporabo zdravila je odgovoren
The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Mediana starost bolnikov je bila 63 let (razpon: 39-85), 44 % bolnikov je bilo starih ≥ 65 let, 11 % bolnikov pa ≥ 75 let.
In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
V študiji 1. faze MDX1106-03 so o pnevmonitisu, vključno s stopnjo 4 pri 1 bolniku, poročali pri 3/37 bolnikov (8,1 %) z NSCLC, ki so prejemali nivolumab v odmerku 3 mg/kg.
Based on this prescribed dose, calculate the total dose to be given.
Na osnovi predpisanega odmerka izračunajte celotni odmerek, ki ga boste aplicirali bolniku.
In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Poleg tega pa so vrednotili tudi izboljšanje simptomov in splošno zdravstveno stanje s pomočjo povprečnega indeksa bremena simptomov na lestvici LCSS (Lung Cancer Symptom Score) in vizualni analogni lestvici EQ-5D (EQ-VAS).
Do not store any unused portion of the infusion solution for reuse.
Neporabljene raztopine za infundiranje ne shranjujte za ponovno uporabo.
The effects of Nivolumab BMS in pregnant women are not known, but it is possible that the active substance, nivolumab, could harm an unborn baby.
Učinki zdravila Nivolumab BMS pri nosečnicah niso znani, vendar pa obstaja možnost, da zdravilna učinkovina nivolumab škoduje nerojenemu otroku.
See the end of section 4 for how to report side effects.
Glejte na koncu poglavja 4, kako poročati o neželenih
Inflammation of the skin that can lead to rash and itching.
vnetje kože, ki lahko povzroči izpuščaj in srbenje.
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Zdravilo mora pripraviti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede aseptičnih pogojev.
No dose adjustment is required for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Pri starejših bolnikih (≥ 65 let) odmerka ni treba prilagajati (glejte poglavji 5.1 in 5.2).
Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis.
Pri osmih bolnikih, vključno s 4 bolniki s primerom stopnje 3, je bilo zaradi pnevmonitisa zdravljenje z nivolumabom treba trajno ukiniti.
Thirty-one percent had progressive disease reported as the best response to their most recent prior regimen and 45% received nivolumab within 3 months of completing their most recent prior regimen.
Pri 31 % bolnikov je bolezen pri zadnjem predhodnem režimu zdravljenja napredovala, 45 % bolnikov pa je nivolumab prejelo v 3 mesecih po dokončanju zadnjega predhodnega režima zdravljenja.
Nivolumab BMS should not be frozen.
Zdravila Nivolumab BMS ne smete zamrzovati.
Only 4 (0.8%) patients were persistent positive.
Kot trajno pozitivne so označili le 4 bolnike (0,8 %).
There was a dose-dependent increase in foetal losses and increased neonatal mortality beginning in the third trimester.
Poročali so o od odmerka odvisnem povečanju izgub plodov in o večji neonatalni umrljivosti od tretjega trimesečja dalje.
Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Zdravnik se bo z vami pogovoril o možnih neželenih učinkih in vam pojasnil vsa tveganja in koristi
The recommended dose is 3 mg of nivolumab per kilogram of your body weight.
Priporočeni odmerek je 3 mg nivolumaba na kilogram telesne mase.
You will receive treatment with Nivolumab BMS in a hospital or clinic, under the supervision of an experienced doctor.
Zdravilo Nivolumab BMS boste prejeli v bolnišnici pod nadzorom zdravnika z ustreznimi izkušnjami.
Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
V študiji CA209017 o hiperparatiroidizmu sicer niso poročali, vendar pa je treba razmisliti o imunsko pogojenem hiperparatiroidizmu, še posebej v povezavi s hipofosfatemijo (v tej študiji so o njej poročali pri 6 bolnikih s hiperkalciemijo).
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients.
Nevtralizirajoča protitelesa so odkrili le pri 5 bolnikih (1,0 % vseh), ki so bili pozitivni na protitelesa proti zdravilu.
The prescribed dose for the patient is given in mg/kg.
Predpisani odmerek za bolnika je podan v mg/kg.
The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes.
Preostali mladiči samic, ki so prejemale nivolumab, so preživeli do predvidenega časa, brez kliničnih znakov, povezanih z uporabo zdravila, sprememb v normalnem razvoju, vplivov na maso organov ali makroskopskih in mikroskopskih patoloških sprememb.
Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Tumours, version 1.1) je bilo izvedeno 9 tednov po randomizaciji, nato pa se je nadaljevalo na vsakih 6 tednov.
Do not take any other medicines during your treatment without talking to your doctor first.
Med zdravljenjem ne jemljite nobenega drugega zdravila, ne da bi se o tem najprej posvetovali z
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v
From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Z mikrobiološkega stališča je treba zdravilo infundirati ali razredčiti in infundirati takoj po odprtju
As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Ker se monoklonska protitelesa ne presnavljajo z encimi citokroma P450 (CYP) ali drugimi presnovnimi encimi, ne pričakujemo, da bi zaviranje ali indukcija teh encimov zaradi sočasne uporabe drugih zdravil vplivala na farmakokinetiko nivolumaba.
Studies to evaluate the effect of nivolumab on fertility have not been performed.
Študij, ki bi ovrednotile vpliv nivolumaba na plodnost, niso izvedli.
What you need to know before you use Nivolumab BMS You should not be given Nivolumab BMS if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Zdravila Nivolumab BMS ne smete prejeti če ste alergični na nivolumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 “Vsebina pakiranja in dodatne informacije”).
If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 4 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Če se zdravila ne uporabi takoj, se raztopino lahko za največ 24 ur shrani v hladilniku (2 °C do 8 °C), zaščiteno pred svetlobo [od skupnih 24 ur je raztopina lahko največ 4 ure pri sobni temperaturi (20 °C do 25 °C) in sobni svetlobi].
Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group).
V študijo CA209017 je bilo vključeno omejeno število bolnikov, starih ≥ 75 let (11 bolnikov v skupini, ki je prejemala nivolumab, in 18 bolnikov v skupini, ki je prejemala docetaksel).
The updated data should be submitted by 31st December
Dopolnjene podatke je treba predložiti do
Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Če se ne ugotovi drugačne etiologije, je treba znake in simptome endokrinopatij obravnavati kot imunsko pogojene.
STEP 2 Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or
Koncentrat prenesite v sterilno, izpraznjeno steklenico ali intravenski vsebnik (PVC ali
Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Nivolumab je pridobljen s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Before treatment, your doctor will check your general health.
Pred uvedbo zdravljenja bo zdravnik preveril vaše splošno zdravstveno stanje, med zdravljenjem pa opravljal krvne preiskave.
It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Nivolumab je monoklonsko protitelo, vrsta beljakovine, ki prepozna in se pritrdi na posebno ciljno
There were no reports of hypophysitis, diabetes mellitus, or diabetic ketoacidosis in these studies.
O primerih vnetja hipofize, sladkorne bolezni ali diabetične kotoacidoze v teh študijah niso poročali.
Patients on controlled sodium diet
Bolniki na dieti z nadzorovanim vnosom natrija
Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease.
Pri bolnikih se lahko pojavijo utrujenost, glavobol, spremembe duševnega stanja, bolečina v trebuhu, neobičajno odvajanje blata in hipotenzija ali nespecifični simptomi, ki lahko spominjajo na druge vzroke, kot so zasevki v možganih ali osnovna bolezen.
No cases of overdose have been reported in clinical trials.
V kliničnih preskušanjih niso poročali o primerih prevelikega odmerjanja.
Nivolumab BMS acts on your immune system and may cause inflammation in parts of your body.
Zdravilo Nivolumab BMS deluje na imunski sistem in lahko povzroči vnetje posameznih delov telesa.
Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines.
Na osnovi farmakodinamičnih lastnosti nivolumaba je njegov vpliv na sposobnost vožnje in upravljanja s stroji malo verjeten.
Patients with active autoimmune disease, symptomatic interstitial lung disease, or untreated brain metastasis were excluded from the study.
Bolnike z aktivno avtoimunsko boleznijo, simptomatsko boleznijo pljučnega intersticija ali nezdravljenimi zasevki v možganih so iz študije izključili.
It is very important for you to keep all your appointments to receive Nivolumab BMS.
Zelo pomembno je, da prejmete vse predvidene odmerke zdravila Nivolumab BMS.
The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab.
Preliminarni rezultati kažejo, da sistemska imunosupresija po začetku zdravljenja z nivolumabom ne prepreči odziva na nivolumab.
Of the 497 patients who were treated with nivolumab 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 51 (10.3%) patients tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Od 497 bolnikov, ki so se zdravili z nivolumabom v odmerku 3 mg/kg na vsaka 2 tedna, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 51 bolnikov (10,3 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu.
It is available in packs containing either 1 vial of 4 mL or 1 vial of 10 mL.
Zdravilo je na voljo v pakiranjih, ki vsebujejo 1 vialo s 4 ml zdravila ali 1 vialo z 10 ml zdravila.
Patients should be monitored for clinical signs and symptoms of endocrinopathies and for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Bolnike je treba nadzirati glede pojava kliničnih znakov in simptomov endokrinopatij in sprememb delovanja ščitnice (ob uvedbi zdravljenja, periodično med zdravljenjem in kot je indicirano na osnovi kliničnega pregleda).