natgillin/translations-raw huggingface dataset:
HER2 testing must be performed in a specialised laboratory which can ensure adequate validation of the testing procedures (see 5.1).
Testiranje za HER2 mora biti opravljeno v specializiranem laboratoriju, ki lahko zagotavlja ustrezno validacijo postopka testiranja (glejte poglavje 5. 1).
4 Currently no data from clinical trials are available on Herceptin re-treatment of patients with previous exposure to Herceptin in the adjuvant setting.
Trenutno ni na voljo podatkov iz kliničnih preskušanj, kjer bi bili bolniki po adjuvantnem zdravljenju z zdravilom Herceptin z njim ponovno zdravljeni.
The use of Herceptin is associated with cardiotoxicity.
Uporaba zdravila Herceptin je povezana s kardiotoksičnostjo.
All candidates for treatment should undergo careful cardiac monitoring (see “ cardiotoxicity” section below). The risk of cardiotoxicity is greatest when Herceptin is used in combination with anthracyclines.
Tveganje za kardiotoksičnost je največje pri kombinaciji zdravila Herceptin in antraciklinov.
Therefore Herceptin and anthracyclines should not be used currently in combination except in a well-controlled clinical trial setting with cardiac monitoring.
Zato se kombinacija zdravila Herceptin in antraciklinov v splošnem ne uporablja, razen v dobro nadzorovanih kliničnih preskušanjih s kontrolo srčnih funkcij.
Patients who have previously received anthracyclines are also at risk of cardiotoxicity with Herceptin treatment, although the risk is lower than with concurrent use of Herceptin and anthracyclines.
Pri bolnikih, ki so se predhodno zdravili z antraciklini, pri zdravljenju z zdravilom Herceptinom tveganje za kardiotoksičnost še vedno obstaja, le da je manjše kot pa pri sočasni uporabi zdravila Herceptin in antraciklinov.
Because the half-life of Herceptin is approximately 28.5 days (95% confidence interval, 25.5 – 32.8 days), Herceptin may persist in the circulation for up to 24 weeks after stopping Herceptin treatment.
Ker je razpolovni čas zdravila Herceptin približno 28, 5 dni (95 -% interval zaupanja, 25, 5−32, 8 dni), je lahko zdravilo Herceptin po prenehanju zdravljenja prisotno v krvnem obtoku do 24 tednov.
Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiotoxicity.
Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja z zdravilom Herceptin, lahko obstaja večje tveganje za kardiotoksičnost.
If possible, physicians should avoid anthracycline- based therapy for up to 24 weeks after stopping Herceptin.
Če je možno, se po prekinitvi zdravljenja z zdravilom Herceptin do 24 tednov izogibamo zdravljenju z antraciklini.
If anthracyclines are used, the patient’ s cardiac function should be monitored carefully (see “ cardiotoxicity” section below).
Če bolnika zdravimo z antraciklini, je treba skrbno spremljati njegove srčne funkcije (glejte poglavje “ kardiotoksičnost ” spodaj).
Serious adverse reactions including infusion reactions, hypersensitivity, allergic-like reactions and pulmonary events have been observed in patients receiving Herceptin therapy.
Pri bolnikih, ki so bili zdravljeni z zdravilom Herceptin, so se pojavili hudi neželeni učinki, kot so infuzijske reakcije, preobčutljivost, alergiji podobne reakcije in pljučni zapleti.
Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Pri bolnikih z dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenj, obstaja večje tveganje infuzijske reakcije s smrtnim izidom.
These severe reactions were usually associated with the first infusion of Herceptin and generally occurred during or immediately following the infusion.
Te hude reakcije so ponavadi povezane s prvo infuzijo zdravila Herceptin in so se običajno pojavile med ali takoj po infuziji.
For some patients, symptoms progressively worsened and led to further pulmonary complications.
Pri nekaterih bolnikih so se simptomi progresivno slabšali in vodili do nadaljnih pljučnih zapletov.
Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Pojavili so se tudi primeri začetnega izboljšanja, ki mu je sledilo klinično poslabšanje in zapoznele reakcije s hitrim kliničnim poslabšanjem.
Fatalities have occurred within hours and up to one week following infusion.
Smrtni primeri so se pojavili v nekaj urah ali do enega tedna po infuziji.
On very rare occasions, patients have experienced the onset of infusion symptoms or pulmonary symptoms more than six hours after the start of the Herceptin infusion.
V zelo redkih primerih so se infuzijski ali pljučni simptomi pojavili več kot šest ur po začetku infuzije zdravila Herceptin.
Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Bolnike je potrebno opozoriti na možnosti tako poznega pojava simptomov in jim svetovati, da takoj obvestijo svojega zdravnika, če se ti simptomi pojavijo.
Infusion reactions, allergic-like reactions and hypersensitivity Serious adverse reactions to Herceptin infusion that have been reported infrequently include dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema (see 4.8).
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Hudi neželeni učinki ob infuziji zdravila Herceptin, ki so se redko pojavili, vključujejo dispnejo, hipotenzijo, sopenje, hipertenzijo, bronhospazem, supraventrikularno tahiaritmijo, zmanjšano nasičenost arterijske krvi s kisikom, anafilaksijo, respiratorni distres sindrom, koprivnico in angioedem (glejte poglavje 4. 8).
The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Večina teh učinkov se pojavi med ali v 2, 5 urah po začetku prve infuzije.
Should an infusion reaction occur the Herceptin infusion should be discontinued and the patient monitored until resolution of any observed symptoms (see 4.2).
Če se pojavi infuzijska reakcija, je potrebno infuzijo zdravila Herceptin prekiniti in bolnika nadzorovati, dokler simptomi ne izzvenijo (glejte poglavje 4. 2).
The majority of patients experienced resolution of symptoms and subsequently received further infusions of Herceptin.
Pri večini bolnikov so simptomi izzveneli in so z infuzijami zdravila Herceptin nadaljevali.
Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Hude reakcije so uspešno zdravili s podpornim zdravljenjem kot so kisik, beta agonisti in kortikosteroidi.
In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
V redkih primerih so bile te reakcije povezane s kliničnim potekom, ki je dosegel vrhunec s smrtnim izidom.
Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenj, obstaja večje tveganje infuzijske reakcije s smrtnim izidom.
Therefore, these patients should not be treated with Herceptin (see 4.3).
Zato takih bolnikov ne smemo zdraviti z zdravilom Herceptin (glejte poglavje 4. 3).
Pulmonary events Severe pulmonary events have been reported rarely with the use of Herceptin in the post-marketing setting (see 4.8).
Pljučni zapleti Med postmarketinškimi izkušnjami so se pri uporabi zdravila Herceptin hudi neželeni pljučni zapleti pojavili redko (glejte poglavje 4. 8).
These rare events have occasionally been fatal.
Redki primeri so se končali s smrtnim izidom.
In addition, rare cases of pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Pojavili so se tudi redki primeri pljučnih infiltratov, akutni respiratorni distres sindrom, pljučnica, pnevmonitis, plevralni izliv, respiratorni distres sindrom, akutni pljučni edem in respiratorna insuficienca.
Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenj, obstaja večje tveganje pljučnih zapletov.
Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.
Pozorno je treba spremljati znake pnevmonitisa, še posebej pri bolnikih, ki se sočasno zdravijo s taksani.
5 following anthracycline (doxorubicin or epirubicin )– containing chemotherapy.
5 Kardiotoksičnost Pri bolnikih, ki so po kemoterapiji z antraciklini (doksorubicin ali epirubicin) prejemali zdravilo Herceptin kot monoterapijo ali v kombinaciji s paklitakselom ali docetakselom, se je pojavilo srčno popuščanje (NYHA - New York Heart Association, razred II−IV).
This may be moderate to severe and has been associated with death (see 4.8).
Lahko je zmerno do hudo in povezano s smrtjo (glejte poglavje 4. 8).
All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, ECG, echocardiogram, or MUGA scan or magnetic resonance imaging.
Vsem kandidatom za zdravljenje z zdravilom Herceptin, posebej tistim, ki smo jih predhodno zdravili z antraciklini in ciklofosfamidom, moramo preveriti osnovne srčne funkcije, vključno z anamnezo in fizičnim pregledom, EKG, ehokardiogramom ali radioizotopsko ventrikulografijo ali magnetnoresonančnim slikanjem.
A careful risk-benefit assessment should be made before deciding to treat with Herceptin.
Pred odločitvijo za zdravljenje z zdravilom Herceptin je potrebno skrbno pretehtati razmerje med koristnostjo in tveganjem.
In EBC, the following patients were excluded from the HERA trial, there are no data about the benefit: risk balance, and therefore treatment can not be recommended in such patients: • History of documented CHF • High-risk uncontrolled arrhythmias • Angina pectoris requiring medication • Clinically significant valvular disease • Evidence of transmural infarction on ECG • Poorly controlled hypertension
V klinično preskušanje HERA pri zgodnjem raku dojk niso bili vključeni bolniki z: • anamnezo potrjenega kongestivnega srčnega popuščanja, • nenadzorovano srčno aritmijo z visokim tveganjem, • angino pektoris, ki zahteva zdravljenje, • klinično pomembno boleznijo srčnih zaklopk, • transmuralnim infarktom, potrjenim z EKG, • slabo urejeno hipertenzijo.
Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Za te bolnike ni podatkov o razmerju med koristnostjo in tveganjem, zato zdravljenje zanje ni priporočljivo.
Cardiac function should be further monitored during treatment (e. g. every three months).
Pri bolnikih, kjer so po osnovnem pregledu odkrili kardiovaskularne težave, je treba razmisliti o celovitem kardiološkem pregledu.
Monitoring may help to identify patients who develop cardiac dysfunction.
Med zdravljenjem je potrebno nadzorovati srčne funkcije (npr. vsake tri mesece), kar olajša razpoznavo bolnikov, pri katerih se pojavijo motnje v delovanju srca.
For early breast cancer patients, cardiac assessment, as performed at baseline, should be repeated every 3 months during treatment and at 6, 12 and 24 months following cessation of treatment.
Pri bolnikih z zgodnjim rakom dojk je treba pregled osnovnih srčnih funkcij ponoviti vsake 3 mesece med zdravljenjem, po končanem zdravljenju pa po 6, 12 in 24 mesecih.
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e. g. every 6-8 weeks).
Za bolnike z asimptomatičnimi motnjami v delovanju srca je pogostejši nadzor koristen (npr. vsakih 6−8 tednov).
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herceptin therapy has been seen.
Pri bolnikih s kontinuiranim upadanjem funkcije levega ventrikla, ki pa ostajajo asimptomatični, naj zdravnik razmisli o ukinitvi zdravljenja z zdravilom Herceptin, če klinična korist ni opazna.
Caution should be exercised in treating patients with symptomatic heart failure, a history of hypertension or documented coronary artery disease, and in early breast cancer, in those patients with an LVEF of 55% or less.
Pri zgodnjem raku dojk pa pri bolnikih, ki imajo iztisni delež levega prekata (LVEF) 55% ali manj.
If LVEF drops 10 ejection points from baseline AND to below 50%, Herceptin should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Če LVEF pade za 10 točk od začetne vrednosti IN pod 50%, dajanje zdravila Herceptin prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
If LVEF has not improved, or declined further, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom Herceptin, razen če je korist za posameznega bolnika večja od tveganja.
If symptomatic cardiac failure develops during Herceptin therapy, it should be treated with the standard medications for this purpose.
Če se med zdravljenjem z zdravilom Herceptin razvije simptomatsko srčno popuščanje, ga zdravimo s standardnimi zdravili za ta namen.
Discontinuation of Herceptin therapy should be strongly considered in patients who develop clinically significant heart failure unless the benefits for an individual patient are deemed to outweigh the risks.
Resen razmislek o prekinitvi zdravljenja z zdravilom Herceptin je potreben pri bolnikih, pri katerih se razvije klinično značilno srčno popuščanje, razen če je korist za posameznega bolnika večja kot tveganje.
The safety of continuation or resumption of Herceptin in patients who experience cardiotoxicity has not been prospectively studied.
Varnosti nadaljevanja ali ponovnega dajanja zdravila Herceptin pri bolnikih, pri katerih se je pojavila kardiotoksičnost, niso proučevali prospektivno.
However, most patients who developed heart failure in the pivotal trials improved with standard medical treatment.
V ključnih preskušanjih se je pri večini bolnikov, pri katerih se je razvilo srčno popuščanje, stanje izboljšalo s standardnim zdravljenjem.
This included diuretics, cardiac glycosides, beta- blockers and/ or angiotensin-converting enzyme inhibitors.
To vključuje diuretike, srčne glikozide, blokatorje receptorjev beta in/ ali zaviralce angiotenzinske konvertaze.
The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on weekly therapy with Herceptin without additional clinical cardiac events.
Pri večini bolnikov s srčnimi simptomi in znaki klinične koristi zdravljenja z zdravilom Herceptin, je nadaljevanje tedenskega zdravljenja z zdravilom Herceptin potekalo brez dodatnih kliničnih zapletov v delovanju srca.
4.6 Pregnancy and lactation
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Pregnancy
6 4. 6 Nosečnost in dojenje
6 Reproduction studies have been conducted in cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/ kg Herceptin and have revealed no evidence of impaired fertility or harm to the foetus.
Nosečnost Študije o vplivu na sposobnost razmnoževanja so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25- krat večji od tedenskega vzdrževalnega odmerka zdravila Herceptin pri ljudeh (2 mg/ kg).
Placental transfer of trastuzumab during the early (Days 20– 50 of gestation) and late (Days 120– 150 of gestation) foetal development period was observed.
Opazili so prehod trastuzumaba preko placente v zgodnjem (20−50 dan gestacije) in v poznem (120−150 dan gestacije) obdobju razvoja ploda.
It is not known whether Herceptin can cause foetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Ni znano, ali lahko zdravilo Herceptin škodljivo vpliva na plod, ko ga prejema noseča ženska ali če lahko vpliva na sposobnost razmnoževanja.
As animal reproduction studies are not always predictive of human response, Herceptin should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Rezultati študij o vplivu na sposobnost razmnoževanja na živalih niso vedno prenosljivi na ljudi, zato se moramo uporabi zdravila Herceptin med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
In the postmarketing setting, cases of oligohydramnios have been reported in pregnant women receiving Herceptin.
V postmarketinškem obdobju so pri nosečnicah, ki so prejemale zdravilo Herceptin, poročali o nekaterih primerih oligohidramnija.
Lactation A study conducted in lactating cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/ kg Herceptin demonstrated that trastuzumab is secreted in the milk.
Dojenje Rezultati študije, opravljene pri doječih opicah Cynomolgus z odmerki, 25- krat večjimi od tedenskega vzdrževalnega odmerka zdravila Herceptin pri ljudeh (2 mg/ kg), so pokazali, da se trastuzumab izloča v mleko.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Herceptin therapy and for 6 months after the last dose of Herceptin.
Ker se humani IgG izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem z zdravilom Herceptin in še 6 mesecev po zadnjem odmerku zdravila Herceptin.
No studies on the effects on the ability to drive and to use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
Bolniki, pri katerih se pojavijo simptomi povezani z infuzijo, ne smejo voziti avtomobilov ali upravljati strojev, dokler simptomi ne izzvenijo.
MBC
Metastatski rak dojk
The adverse event data reflect the clinical trial and post marketing experience of using Herceptin at the recommended dose regimen, either alone or in combination with paclitaxel.
Podatki o neželenih učinkih izhajajo iz kliničnih preskušanj in postmarketinških izkušenj z zdravilom Herceptin pri priporočenem odmerjanju, bodisi samim ali v kombinaciji s paklitakselom.
Patients received Herceptin as monotherapy or in combination with paclitaxel in the two pivotal clinical trials.
Bolniki so prejemali zdravilo Herceptin kot monoterapijo ali v kombinaciji s paklitakselom v dveh ključnih kliničnih preskušanjih.
The most common adverse reactions are infusion-related symptoms, such as fever and chills, usually following the first infusion of Herceptin.
Najpogostejši neželeni učinki so bili simptomi povezani z infuzijo, kot so zvišana telesna temperatura in mrazenje, ponavadi po prvi infuziji zdravila Herceptin.
Adverse reactions attributed to Herceptin in ≥ 10% of patients in the two pivotal clinical trials were the following:
Neželeni učinki, ki so se pojavili pri ≥ 10% bolnikov v dveh ključnih kliničnih preskušanjih z zdravilom Herceptin, so bili:
Body as a Whole:
Prebavila:
Musculoskeletal:
Mišično- skeletni sistem:
Skin and appendages:
Koža in kožni priveski:
abdominal pain, asthenia, chest pain, chills, fever, headache, pain diarrhoea, nausea, vomiting arthralgia, myalgia Rash
driska, slabost, bruhanje. artralgija, mialgija. kožni izpuščaj.
Adverse reactions attributed to Herceptin in > 1% and < 10% of patients in the two pivotal clinical trials were the following:
7 Neželeni učinki, ki so se v dveh ključnih kliničnih preskušanjih z zdravilom Herceptin pojavili pri > 1% in < 10% bolnikov, so bili:
influenza-like illness, back pain, infection, neck pain, malaise, hypersensitivity reaction, mastitis, weight loss
bolezen podobna gripi, bolečina v hrbtu, okužbe, bolečina v vratu, Splošni: neugodje, preobčutljivostna reakcija, mastitis, izguba telesne mase. vazodilatacija, supraventrikularna tahiaritmija, hipotenzija, srčno Kardiovaskularni sistem: popuščanje, kardiomiopatija, palpitacije. anoreksija, zaprtje, dispepsija, napetost in bolečina v predelu jeter, suha Prebavila: usta, bolezni danke (hemoroidi).
Cardiovascular:
Kri in limfni sistem:
Blood and lymphatic:
Presnovni sistem:
Psychiatric disorders
Živčni sistem:
peripheral oedema, oedema bone pain, leg cramps, arthritis dizziness, paraesthesia, somnolence, hypertonia, peripheral neuropathy, tremor anxiety, depression, insomnia,
levkopenija, ekhimoza. periferni edem, edem. bolečine v kosteh, krči v nogah, artritis. omotica, mravljinčenje, zaspanost, hipertonija, periferna nevropatija, tremor.
Respiratory:
Respiratorni sistem:
asthma, cough increased, dyspnoea, epistaxis, lung disorders, pharyngitis, rhinitis, sinusitis
anksioznost, depresija, nespečnost. astma, pogostejši kašelj, dispneja, epistaksa, motnje delovanja pljuč, faringitis, rinitis, sinusitis.
Urogenital:
Urogenitalni sitem:
urinary tract infection pruritus, sweating, nail disorder, dry skin, alopecia, acne, maculopapular rash
okužbe urinarnega trakta. pruritus, znojenje, spremembe na nohtu, suha koža, alopecija, akne, makulopapularni izpuščaj.
Special senses:
Čutila:
taste perversion
motnje okušanja.
In a further randomised clinical trial (M77001), patients with metastatic breast cancer received docetaxel, with or without Herceptin.
V dodatnem randomiziranem kliničnem preskušanju (M77001) so bolniki z metastatskim rakom dojk prejemali docetaksel z zdravilom Herceptin ali brez njega.
The following table displays adverse events which were reported in ≥ 10% of patients, by study treatment:
Spodnja preglednica prikazuje neželene dogodke, o katerih so poročali pri ≥ 10% bolnikov pri zdravljenju med študijo:
Common Non-haematological Adverse Events Reported in ≥ 10% of Patients, by Study Treatment
Skupni nehematološki neželeni dogodki, o katerih so poročali pri ≥ 10% Preglednica 1 bolnikov pri obeh študijskih skupinah
Herceptin plus docetaxel docetaxel
docetaksel
Adverse Event
Neželeni dogodek
N = 92 (%)
docetaksel n = 92 (%)
asthenia oedema peripheral fatigue mucosal inflammation
astenija periferni edem utrujenost vnetje sluznice
administration site
spremembe na mestu
pain lethargy chest pain influenza like illness rigors alopecia
letargija bolečina v prsih bolezen podobna gripi rigor alopecija
Skin and subcutaneous tissue disorders Gastrointestinal
Bolezni kože in podkožja
nail disorder rash erythema nausea diarrhoea vomiting
spremembe na nohtu kožni izpuščaj eritem
constipation
navzea diareja
32 21
43 43
21 18
41 36
Herceptin plus docetaxel
docetaksel Zdravilo Herceptin in
dysgeusia hypoaesthesia
Bolezni živčevja
14 11
14 11 23
12 5
12 5 17
Musculoskeletal and connective tissue disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva Bolezni dihal, prsnega
arthralgia pain in extremity back pain bone pain cough
artralgija bolečina v udih bolečina v hrbtu bolečina v kosteh kašelj
27 16 10 14 13
27 16 10 14 13
Respiratory, thoracic and mediastinal disorders Infections and
mediastinalnega
dyspnoea pharyngolaryngeal pain epistaxis rhinorrhoea
bolečina v grlu in žrelu
infestations
parazitske bolezni
Vascular disorders Metabolism and
Žilne bolezni Presnovne in
lymphoedema
limfni edem
nutrition disorders
prehranske motnje
Investigations Psychiatric disorders Injury, poisoning and
Preiskave Psihiatrične motnje Poškodbe in
weight increased insomnia
zvečanje telesne mase nespečnost
procedural complications 1
zastrupitve 1
nail toxicity
toksičnost za nohte