natgillin/translations-raw huggingface dataset:
The ziconotide dose should be reduced or discontinued if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, but other contributing causes should also be considered.
Dozu zikonotida treba smanjiti ili obustaviti ako se razviju znakovi ili simptomi kognitivnog oštećenja ili neuropsihijatrijske nuspojave, ali je potrebno uzeti u obzir i druge uzroke koji mogu pridonijeti njihovoj pojavi.
- If you have any of the following symptoms: high temperature, headache, stiff neck, tiredness, confusion, feeling sick, vomiting or occasional fits, these may be signs of meningitis.
- Ako imate neki od sljedećih simptoma: visoka temperatura, glavobolja, ukočen vrat, umor, smetenost, osjećaj mučnine, povraćanje ili povremeni napadaji, to mogu biti znakovi meningitisa.
Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e.g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e.g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Na temelju ograničenih kliničkih istraživanja, i inhibitori angiontenzin konvertirajućeg enzima (npr. benazepril, lizinopril i moeksipril) i inhibitori proteaza HIV-a (npr. ritonavir, sakvinavir, indinavir), nemaju očigledan učinak na razinu zikonotida u plazmi.
The generated free amino acids are expected to be taken up by cellular carrier systems and either subjected to normal intermediary metabolism or used as substrates for constitutive biosynthetic processes.
Očekuje se da će tako nastale slobodne aminokiseline preuzeti stanični prijenosni sustavi te da će postati ili dio normalnog intermedijarnog metabolizma ili supstrati konstitutivnih biosintetskih procesa.
Medicinal products that affect specific peptidases/proteases would not be expected to impact upon ziconotide plasma exposure.
Ne očekuje se da bi lijekovi koji utječu na specifične peptidaze/proteaze utjecali na koncentraciju zikonotida u plazmi.
Progressive elevation of the creatine kinase is uncommon.
Progresivno povišenje kreatin kinaze nije često.
Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; < 0.04 ng/ml).
Plazmatske koncentracije nakon neprekinute (≥ 48 h) intratekalne infuzije (≤ 21,6 μg/dan) čini se da su relativno niske i u pravilu se ne mogu detektirati (tj. oko 80% uzoraka plazme uzetih od bolesnika s bolovima ne sadrže mjerljivu količinu lijeka; < 0,04 ng/ml).
Metabolism and nutrition disorders appetite decreased, anorexia
Poremećaji metabolizma i prehrane smanjeni apetit, anoreksija
Clinical studies 201 and 202 indicate that the combination of IT ziconotide and IT morphine may effectively reduce pain and decrease systemic opioid use over a sustained period of time for patients whose pain was inadequately controlled with their maximum tolerated dose of IT ziconotide (median 8.7 μg/day, mean 25.7 μg/day - study 201) or with IT morphine (study 202) alone.
Klinička ispitivanja 201 i 202 pokazuju da kombinacija intratekalnog zikonotida i intratekalnog morfina može učinkovito smanjiti bol te tijekom kontinuiranog razdoblja smanjiti sistemsku primjenu opioida u bolesnika u kojih bol nije bila odgovarajuće kontrolirana primjenom maksimalno podnošljive doze samo intratekalnog zikonotida (medijan 8,7 μg/dan, srednja vrijednost 25,7 μg/dan - ispitivanje 201) ili intratekalnog morfina (ispitivanje 202).
Low plasma exposure occurs during IT infusion due to the low recommended IT infusion rates and relatively rapid plasma clearance (see section 5.2).
Niska izloženost plazme događa se tijekom intratekalne infuzije zbog malih preporučenih brzina intratekalne infuzije a relativno brzog klirensa plazme (vidjeti dio 5.2).
Hypersensitivity reactions, including anaphylaxis, have not been observed during clinical trials and the immunogenicity of ziconotide administered by the IT route appears to be low.
Reakcije preosjetljivosti, uključujući anafilaksiju, nisu opažene tijekom kliničkih ispitivanja i čini se da je imunogeničnost zikonotida primijenjenog intratekalno mala.
Vomiting and anorexia, and peripheral oedema were also observed when IT ziconotide was added to IT morphine.
Povraćanje i anoreksija te periferni edem također su opaženi kad se intratekalni zikonotid dodavao intratekalnom morfinu.
Efficacy results from study 301
Rezultati djelotvornosti u ispitivanju 301
It is unlikely that the degradation products of ziconotide will have significant biological activity, as peptides consisting of the individual peptide loop structures have been found to have binding affinities for N-type voltage sensitive calcium channels that are several orders of magnitude lower than that of the parent (ziconotide) compound.
Nije vjerojatno da će razgradni produkti zikonotida imati značajno biološko djelovanje, jer je nađeno da peptidi sastavljeni od pojedinačnih struktura peptidne petlje imaju nekoliko puta manji afinitet vezanja za kalcijeve kanale osjetljive na napon N-tipa nego osnovni spoj (zikonotid).
- If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection.
- Opazite li znakove infekcije oko cjevčice, kao što je crvenilo kože, oticanje, bol ili iscjedak, obratite se odmah liječniku i zatražite liječenje infekcije.
Chemical and physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the pump has not previously been exposed to the medicinal product.
Kemijska i fizikalna stabilnost u primjeni u trajanju od 14 dana pri temperaturi od 37°C dokazana je u pumpi Synchromed kada pumpa prethodno nije bila izložena lijeku.
Most adverse reactions were mild to moderate in severity and resolved over time.
Većina nuspojava bile su blagog do umjerenog intenziteta i s vremenom su nestale.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza "Rok valjanosti" / "EXP".
However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma protein binding (see section 5.2) make metabolic-based interactions or plasma protein displacement type interactions between ziconotide and other medicinal products unlikely.
Međutim, zbog niskih koncentracija zikonotida u plazmi, metabolizma preko ubikvitarnih peptidaza i relativno niskog vezanja na proteine plazme (vidjeti dio 5.2), interakcije na temelju metabolizma ili interakcije u obliku izmještanja s proteina plazme nisu vjerojatne između zikonotida i drugih lijekova.
The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the surfaces of the device, and/or dilution by the residual space of the device.
Koncentracija Prialta u pumpi koja prije nije bila upotrijebljena može se smanjiti zbog adsorpcije na površinama uređaja i/ili razrjeđenja u preostalom prostoru uređaja.
Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions.
Doziranje zikonotida treba započeti dozom od 2,4 μg/dan i zatim titracijom prilagoditi svakom pojedinom bolesniku prema njegovom analgetičkom odgovoru i nuspojavama.
If you are experiencing depression or have a history of depression please inform your healthcare professional before you are commenced on Prialt.
Ako imate depresiju ili ste je imali u prošlosti, molimo Vas da o tome obavijestite zdravstvenog djelatnika prije nego što počnete primati Prialt.
IT and intravenous pharmacokinetics data are summarised below.
Podaci intratekalne i intravenske farmakokinetike sažeto su prikazani u nastavku.
Prialt is supplied as a clear, colourless solution in single use vials.
Prialt se isporučuje kao bistra, bezbojna otopina u bočicama za jednokratnu uporabu.
The aetiologies of pain in studies 95-001 (malignant pain) and 96-002 (non-malignant pain) were varied and included bone pain (n = 38) mostly due to bone metastases (n = 34), myelopathy (n = 38), half of whom had spinal cord injury with paralysis (n = 19), neuropathy (n = 79), radiculopathy (n = 24), spinal pain (n = 91) mostly due to failed back surgery (n = 82), and other aetiologies (n = 82).
Etiologije bola u ispitivanju 95-001 (maligna bol) i 96-002 (nemaligna bol) bile su različite i uključivale su bol kostiju (n = 38) uglavnom zbog metastaza u kostima (n = 34), mijelopatiju (n = 38), od čega je pola bolesnika imalo ozljedu kralježnične moždine s paralizom (n = 19), neuropatiju (n = 79), radikulopatiju (n = 24), spinalnu bol (n = 91) većinom zbog neuspjelog kirurškog zahvata (n = 82) i bol druge etiologije (n = 82).
Following one-hour IT administration (1 - 10 μg), both cumulative exposure (AUC; range: 83.6608 ng/h/ml) and peak exposure (Cmax; range: 16.4 - 132 ng/ml) values were variable and dose-dependent, but appeared only approximately dose-proportional.
Nakon intratekalne primjene (1 - 10 μg) u trajanju od jednog sata, kumulativna izloženost (AUC; raspon: 83,6 - 608 ng/h/ml) i najviša izloženost (Cmax; raspon: 16,4 - 132 ng/ml) imale su vrijednosti promjenjive i ovisne o dozi, ali činile su se samo približno proporcionalne dozi.
The duration of treatment has ranged from one-hour bolus infusion to continuous use for more than 6 years.
Trajanje liječenja bilo je u rasponu od jednosatne infuzije u obliku bolusa do neprekinute primjene tijekom više od 6 godina.
The most common adverse reactions reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
Najčešće prijavljene nuspojave iz dugotrajnih kliničkih ispitivanja bile su omaglica (42%), mučnina (30%), nistagmus (23%), stanje smetenosti (25%), poremećen hod (16%), oštećenje pamćenja (13%), zamagljen vid (14%), glavobolja (12%), astenija (13%), povraćanje (11%) i somnolencija (10%).
Median ziconotide CSF volume of distribution (Vd: 99 ml) is between the spinal cord CSF volume (approximately 75 ml) and total CSF volume (approximately 130 ml).
Medijan distribucije u volumenu cerebrospinalne tekućine za zikonotid (Vd: 99 ml) nalazi se između volumena cerebrospinalne tekućine u kralježničnoj moždini (približno 75 ml) i ukupnog volumena cerebrospinalne tekućine (približno 130 ml).
In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
U ispitivanjima neprekinute intratekalne infuzije srednjeg trajanja u štakora i pasa, učinci na ponašanje opaženi su pri dozama ≥ 8 puta od najviše preporučene doze kliničke intratekalne infuzije od 21,6 μg/dan (na temelju mg/kg).
The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μg/day following upward titration over 7 days.
U kliničkim ispitivanjima maksimalna namjeravana intratekalna doza zikonotida bila je 912 μg/dan, nakon titracije prema višim vrijednostima u trajanju od 7 dana.
Elevations in creatine kinase
Povišenje kreatin kinaze
Patients and physicians must be vigilant for typical symptoms and signs of meningitis.
Bolesnici i liječnici moraju pozorno pratiti moguću pojavu simptoma i znakova meningitisa.
- In patients that suffer from severe long term pain, there is a higher likelihood of suicide and attempted suicide than in the general population.
- U bolesnika koji trpe dugotrajnu bol postoji veća vjerojatnost za samoubojstvo i pokušaj samoubojstva nego u općoj populaciji.
In the event of progressive elevation, or clinically significant elevation in association with clinical features of myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered.
U slučaju progresivnog povišenja ili klinički značajnog povišenja povezanog s kliničkom slikom miopatije ili rabdomiolize, potrebno je razmotriti prekid primjene zikonotida.
Each vial contains 1, 2 or 5 ml solution for infusion.
Jedna bočica sadrži 1, 2 ili 5 ml otopine za infuziju.
No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
U štakora nisu opaženi učinci na reprodukciju u ženki i postnatalni razvoj pri sistemskoj izloženosti do 2300 puta većoj od izloženosti pri najvećoj preporučenoj intratekalnoj dozi u ljudi.
It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide.
Preporučuje se neuropsihijatrijska procjena bolesnika prije i poslije početka primjene intratekalnog zikonotida.
NCCs regulate neurotransmitter release in specific neuronal populations responsible for the spinal processing of pain.
Blokatori kalcijevih kanala N-tipa reguliraju otpuštanje neurotransmitera u specifičnoj populaciji neurona odgovornih za spinalni prijenos boli.
Although only limited data are available, there is no obvious effect of race, height, weight, gender or age on CSF ziconotide exposure after IT administration.
Iako su dostupni tek ograničeni podaci, pri intratekalnoj primjeni nije opažen utjecaj rase, visine, težine, spola ili dobi na koncentraciju zikonotida u cerebrospinalnoj tekućini.
The majority had spinal pain (n = 134), especially failed back surgery (n = 110); a lower proportion had neuropathy (n = 36).
Većina ih je imala bol u kralježnici (n = 134), a osobito oni s neuspjelim kirurškim zahvatom kralježnice (n = 110); manji je broj imao neuropatiju (n=36).
Clinical efficacy and safety There were three placebo-controlled clinical trials of IT ziconotide.
Klinička djelotvornost i sigurnost Provedena su tri placebom kontrolirana ispitivanja s intratekalnim zikonotidom.
Monitoring of creatine phosphokinase is recommended.
Preporučuje se praćenje kreatin fosfokinaze.
In patients with severe chronic pain there is a higher incidence of suicide and suicide attempts than in the general population.
U bolesnika s teškom kroničnom boli veća je incidencija samoubojstva i pokušaja samoubojstva nego u općoj populaciji.
Due to the wide distribution of these peptidases it is not expected that hepatic or renal impairment would affect the systemic clearance of ziconotide.
Zbog velike raspodjele tih peptidaza ne očekuje se da će oštećenje jetre ili bubrega utjecati na sistemski klirens zikonotida.
In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose.
U ispitivanjima intravenske infuzije, zdravi muški dobrovoljci primili su zikonotid u dozama do 70 000 μg/dan ili 3200 puta većim od najviše preporučene dnevne doze intratekalne infuzije.
Intrathecal use.
Intratekalna primjena.
The use of Prialt has been reported to cause confusion and drowsiness.
Prijavljeno je da primjena lijeka Prialt uzrokuje smetenost i pospanost.
Two short-term studies, 95-001 (malignant pain) and 96-002 (non malignant pain), involving 366 patients, demonstrated the efficacy of IT ziconotide in severe chronic pain using the percent change in Visual Analog Scale of Pain Intensity (VASPI) as the primary efficacy measure.
U dva kratkotrajna ispitivanja, 95-001 (maligna bol) i 96-002 (nemaligna bol) provedena na 366 bolesnika, dokazana je djelotvornost intratekalnog zikonotida u slučaju teške kronične boli na temelju postotka promjene na vizualno analognoj ljestvici za mjerenje intenziteta bola (Visual Analog Scale of Pain Intensity, VASPI) kao primarne mjere djelotvornosti.
General medical supportive measures should be administered to patients who receive an overdose until the exaggerated pharmacological effects of the medicinal product have resolved.
U bolesnika koji prime prekomjernu dozu potrebno je primjenjivati opće potporne mjere liječenja sve dok se ne povuku pretjerani farmakološki učinci lijeka.
Ziconotide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Ne preporučuje se koristiti zikonotid tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Ziconotide appears to distribute mainly within the CSF until transferred to the systemic circulation.
Čini se da se zikonotid raspodjeljuje uglavnom u cerebrospinalnoj tekućini dok ne dospije u sistemsku cirkulaciju.
It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide (see section 4.4).
Preporučuje se neuropsihijatrijska procjena bolesnika prije i poslije početka primjene intratekalnog zikonotida (vidjeti dio 4.4).
There are no or limited amount of data from the use of ziconotide in pregnant women.
Nema podataka ili su podaci o primjeni zikonotida u trudnica ograničeni.
Tell your doctor if you are taking, have recently taken or might take any other medicines (for example, baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used for local anaesthesia, morphine used for pain, propofol used for general anaesthesia, or any medicine which is administered by intrathecal injection (injection into the space that surrounds the spinal cord and the brain)).
Obavijestite liječnika ako uzimate, ako ste nedavno uzeli ili biste mogli uzeti neki drugi lijek (npr. baklofen za liječenje spazma mišića, klonidin za liječenje visokog krvnog tlaka, bupivakain za lokalnu anesteziju, morfij za bol, propofol za opću anesteziju ili neki drugi lijek koji se primjenjuje intratekalnom injekcijom (injekcija koja se daje u prostor oko kralježnične moždine i mozga)).
Following passage into the systemic circulation, ziconotide is expected to be primarily susceptible to proteolytic cleavage by various ubiquitous peptidases/proteases present in most organs (e.g., kidney, liver, lung, muscle, etc.), and thus degraded to peptide fragments and its individual constituent free amino acids.
Nakon ulaza u sistemsku cirkulaciju, očekuje se da će zikonotid biti prvenstveno osjetljiv na proteolitičko cijepanje od strane različitih ubikvitarnih peptidaza/proteaza prisutnih u većini organa (npr. bubreg, jetra, pluća, mišići itd.) pa stoga razgrađen na fragmente peptida i njihove sastavne pojedinačne slobodne aminokiseline.
Nervous system adverse reactions, particularly dizziness, nausea and abnormal gait appear to be correlated with CSF exposure, though a definitive relationship has not been established.
Nuspojave živčanog sustava, osobito omaglica, mučnina i poremećen hod čini se da su u korelaciji s izloženošću cerebrospinalne tekućine, iako točan odnos nije ustanovljen.
The maximum recommended intrathecal dose is 21.6 μg/day.
Najveća preporučena intratekalna doza iznosi 21,6 μg/dan.
Patients and physicians must be vigilant for typical symptoms and signs of meningitis (see section 4.4).
Bolesnici i liječnici trebaju pozorno pratiti moguću pojavu simptoma i znakova meningitisa (vidjeti dio 4.4).
Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Dokazana kemijska i fizikalna stabilnost u primjeni iznosi 60 dana pri 37°C.
PHARMACEUTICAL FORM Solution for infusion (infusion).
OBLIK Otopina za infuziju (infuzija).
Patients should be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day.
Titraciju u bolesnika treba provoditi u povećanjima doze od ≤ 2,4 μg/dan, do najviše doze od 21,6 μg/dan.
If you receive more Prialt than your doctor intended, you may feel unwell with signs such as confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness, excessive sleepiness, feeling or being sick.
Ako primite više lijeka Prialt nego što je to odredio liječnik, možda se nećete osjećati dobro uz znakove kao što su smetenost, teškoće s govorom, otežano nalaženje pravih riječi, prekomjerno drhtanje, ošamućenost, pretjerana pospanost, osjećaj mučnine ili povraćanje.
Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.
Liječenje zikonotidom trebaju provoditi samo liječnici s iskustvom u intratekalnoj primjeni lijekova.
No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.
Nema podataka o istodobnoj primjeni djelomičnih opioidnih agonista (npr. buprenorfina) i zikonotida.
Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Povišenje kreatin kinaze, koje je obično asimptomatsko, često je među bolesnicima koji primaju intratekalni zikonotid.
The concentration of the solution used in the infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an internal pump.
Koncentracija otopine primijenjene infuzijskom pumpom ne smije biti manja od 5 μg/ml zikonotida u vanjskoj pumpi i 25 μg/ml u unutarnjoj pumpi.
The CSF pharmacokinetics of ziconotide have been studied following one-hour IT infusions of 1 - 10 μg of ziconotide in patients with chronic pain.
Farmakokinetika zikonotida u cerebrospinalnoj tekućini ispitana je nakon jednosatnih intratekalnih infuzija od 1 do 10 μg zikonotida u bolesnika s kroničnom boli.
In binding to these neuronal NCCs ziconotide inhibits the voltage sensitive calcium current into primary nociceptive afferents terminating in the superficial layers of the dorsal horn of the spinal cord.
U vezanju za te neuronalne blokatore kalcijevih kanala N-tipa, zikonotid inhibira o naponu ovisan protok kalcija u primarna nociceptivna aferentna živčana vlakna koja završavaju u površinskim slojevima stražnjeg roga kralježnične moždine.
• Anaphylactic reaction (it is not known how many people this affects) - is a severe allergic reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• Anafilaktička reakcija (nije poznato u koliko se osoba može javiti) - teška alergijska reakcija čiji su znakovi iznenadno piskanje, otežano disanje, bol u prsnom košu, oticanje kapaka, lica ili usana, osip ili svrbež (osobito po cijelom tijelu).
- If you are receiving Prialt via a pump worn outside your body, it is important you check once daily for any signs of infection at the point where the tube enters your body.
- Ako primate Prialt s pomoću pumpe koju nosite izvan tijela, važno je da jednom dnevno provjerite da se na mjestu gdje Vam cjevčica ulazi u tijelo nisu pojavili znakovi infekcije.
Symptoms of meningitis are headache, stiff neck, dislike of bright lights, fever, vomiting, confusion and drowsiness.
Simptomi meningitisa su glavobolja, ukočen vrat, nepodnošenje jarkog svjetla, vrućica, povraćanje, smetenost i omamljenost.
Ziconotide (n = 169)b
Zikonotid (n = 169)b
Ziconotide (n = 71)
Zikonotid (n = 71)
- Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
- Jedna bočica od 1 ml sadrži 100 mikrograma; jedna bočica od 2 ml sadrži 200 mikrograma;
However, monitoring of creatine kinase is recommended.
Ipak, preporučuje se praćenje kreatin kinaze.
C. OTHER CONDITIONS AND REQUIREMENTSOF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Each vial contains 20 ml solution for infusion.
Jedna bočica sadrži 20 ml otopine za infuziju.
Investigations blood creatine phosph okinase increase d, weight decreased electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased a. From spontaneous reporting
Pretrage povišena kreatin fosfokinaza u krvi, smanjenje tjelesne težine abnormalnosti u elektrokardiogram u, povišena aspartat aminotransferaza, povišena kreatin fosfokinaza skeletnih mišića u krvi, povišena tjelesna temperatura a Iz spontanih prijava
Eye disorders vision blurred diplopia, visual disturbance, photophobia
Poremećaji oka zamagljen vid diplopija, smetnje vida, fotofobija