natgillin/translations-raw huggingface dataset:
Your doctor will advise you if and when you should start taking these medicines after Zynteglo infusion.
Zdravnik vam bo svetoval, če in kdaj začeti jemati ta zdravila po infuziji zdravila Zynteglo.
Interim results: - at each annual renewal - Dec. 2024 - Dec. 2034
Vmesni rezultati: - ob vsakoletnem podaljšanju - Dec. 2024 - Dec. 2034
This information is provided in the Patient Alert Card which should be given to the patient after treatment.
Te informacije se navedejo v opozorilni kartici bolnika, ki jo je treba dati bolniku po zdravljenju.
• dizziness, or sensation of feeling off balance or like the room is spinning
• vrtoglavica ali občutek neravnotežja, kot da se soba vrti
If a third day of collection was needed, plerixafor and G-CSF dosing was extended to Day 6.
Če je bil potreben tretji dan odvzema, je bil odmerek pleriksaforja in G-CSF podaljšan do 6. dne.
You should carry the Patient Alert Card with you at all times and show it to your doctor or nurse when you see them or if you are admitted to the hospital.
Opozorilno kartico bolnika morate imeti vedno pri sebi in jo pokazati zdravniku ali medicinski sestri, ko ju vidite ali ob morebitnem sprejemu v bolnišnico.
Very Common (≥10%)
Zelo pogosti (≥ 10 %)
• increase in female hormones
• povečanje koncentracije ženskih hormonov
Patients are expected to enrol in a registry and will be followed long term in the registry in order to better understand the long-term safety and efficacy of Zynteglo.
Pričakuje se, da se bolniki vpišejo v register in da bodo dolgoročno spremljani v registru, da bi bolje razumeli dolgoročno varnost in učinkovitost zdravila Zynteglo.
They usually happen within the first few days and several weeks after receiving chemotherapy medicine, but can also develop much later.
Običajno se pojavijo v prvih dneh in nekaj tednih po prejemu zdravila za kemoterapijo, vendar se lahko razvijejo tudi veliko pozneje.
Serological testing
Serološko testiranje
o Signs and symptoms of bleeding and the need to contact the physician if any signs of unusual or prolonged bleeding or any other relevant signs are present.
o Znaki in simptomi krvavitev in potreba po obveščanju zdravnika, če so prisotni znaki nenavadne ali podaljšane krvavitve ali drugi pomembni znaki.
Also contains Cryostor CS5 and sodium chloride.
Vsebuje tudi Cryostor CS5 in natrijev klorid.
Patients seropositive for human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV)
Bolniki, seropozitivni za virus humane imunske pomanjkljivosti (HIV) ali humani T-limfotropni virus (HTLV)
People with this condition cannot make enough haemoglobin, a protein in the blood that carries oxygen.
Osebe s to boleznijo ne morejo tvoriti dovolj hemoglobina, beljakovine v krvi, ki prenaša kisik.
• low number of immature (not fully developed) red blood cells
• nizko število nezrelih (nepopolno razvitih) rdečih krvnih celic
See section 2, Sodium content.
Glejte poglavje 2, Vsebnost natrija.
• infections which may make you feel warm, chilly, or sweaty
• okužbe, zaradi katerih vam je vroče, hladno ali se znojite
Events were mild and included abdominal pain, hot flush, dyspnoea, and non-cardiac chest pain in 9.5%, 2.4%, 2.4%, and 2.4% of patients, respectively.
Dogodki so bili blagi in so vključevali bolečine v trebuhu, vročinske oblive, dispnejo in bolečine v prsnem košu, ki niso povezane s srcem pri 9,5 %, 2,4 %, 2,4 % oz. 2,4 % bolnikov.
• flu like illness
• gripi podobna bolezen
o Details on reporting of adverse effects.
o Podrobnosti o poročanju neželenih učinkov.
To recover and be monitored until your doctor is satisfied that it is safe for you to leave the hospital.
Da si boste opomogli in vas bodo lahko spremljali, dokler vaš zdravnik ne bo presodil, da lahko varno zapustite bolnišnico.
• positive test for Apergillus (lung disease caused by fungus)
• pozitiven test za apergilus (bolezen pljuč, ki jo povzroči glivica)
o Enrolment in the drug product Registry.
o Vključitev v register zdravila.
Your doctor will tell you when your platelet count has recovered to normal levels.
Zdravnik vam bo povedal, ko se bo število trombocitov vrnilo na normalno raven.
Patients should be monitored for thrombocytopenia and bleeding according to standard guidelines.
Bolnike je treba spremljati zaradi trombocitopenije in krvavitve v skladu s standardnimi smernicami.
The safety of Zynteglo was evaluated in 42 patients with TDT.
Varnost zdravila Zynteglo je bilo ocenjena pri 42 bolnikih s TDT.
For women, this may be eggs (oocytes) or ovarian tissue.
Pri ženskah so to lahko jajčea (oociti) ali tkivo jajčnikov.
During the long-term follow-up, your doctor will monitor you for any signs of leukaemia or lymphoma.
Med dolgoročnim spremljanjem vas bo zdravnik spremljal glede znakov levkemije ali limfoma.
Risks associated with TDT and iron overload
Tveganja, povezana s TDT in prenasičenostjo z železom
• low level of red and white blood cells, sometimes with a fever
• nizka raven rdečih in belih krvnih celic, včasih s povišano telesno temperaturo
- The other ingredients are a solution used to preserve frozen cells and sodium chloride.
- Druge sestavine so raztopina, ki se uporablja za ohranjanje zamrznjenih celic, in natrijev klorid.
A patient may have multiple infusion bags.
Bolnik ima lahko več infuzijskih vrečk.
Patients should be assessed for renal impairment defined as creatinine clearance ≤70 mL/min/1.73 m2 to ensure HSC transplantation is appropriate.
Bolnike je treba oceniti za okvaro ledvic, opredeljeno kot očistek kreatinina ≤ 70 ml/min/1,73 m2, da se potrdi primernost presaditve HSC.
Interim report: at each annual renewal
Vmesno poročilo: ob vsakem letnem podaljšanju
Frozen: 1 year at ≤-140°C.
Zamrznjeno: 1 leto pri ≤ -140 °C.
Pharmacotherapeutic group: Other haematological agents, ATC code: not yet assigned Mechanism of action
Farmakoterapevtska skupina: druge hematološke učinkovine, oznaka ATC: še ni bila dodeljena
After treatment with Zynteglo, you will be asked to enrol in a registry for at least 15 years in order to better understand the long-term effects of Zynteglo.
Po zdravljenju z zdravilom Zynteglo vas bodo prosili za vključitev v register za vsaj 15 let za boljše razumevanje dolgoročnih učinkov zdravila Zynteglo.
Your children are still at risk of inheriting your original beta-globin gene.
Pri vaših otrocih še vedno obstaja tveganje, da bodo podedovali vaš osnovni gen za beta-globin.
According to available data, the frequency, type, and severity of adverse reactions in adolescents 12-17 years of age are similar to adults with the exception of VOD and pyrexia that occurred more frequently in adolescents.
Glede na razpoložljive podatke so pogostnost, vrsta in resnost neželenih učinkov pri mladostnikih, starih od 12 do 17 let, podobni tistim pri odraslih, razen jetrne vensko-okluzivne bolezni in pireksije, ki sta se pri mladoletnikih pojavili pogosteje.
Do not overthaw the medicinal product.
Zdravila ne odtajajte preveč.
Zynteglo has not been studied in patients with HIV-1, HIV-2, HTLV-1, or HTLV-2.
Zdravila Zynteglo niso preučili pri bolnikih s HIV-1, HIV-2, HTLV-1 ali HTLV-2.
The safety of immunisation with live viral vaccines during or following Zynteglo treatment has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi med zdravljenjem z zdravilom Zynteglo ali po njem niso preučevali.
No formal drug interaction studies have been performed.
Formalne študije medsebojnega delovanja zdravil niso bile izvedene.
Phlebotomy can be used in lieu of iron chelation, when appropriate.
Namesto kelacije železa se lahko uporablja flebotomija, če je to ustrezno.
This means that your blood may not be able to clot as well as normal and you may be prone to bleeding.
To pomeni, da se vaša kri morda ne bo dobro strjevala in boste dovzetni za krvavitve.
No clinical data on exposed pregnancies are available.
Klinični podatki o nosečnicah, ki so bile izpostavljene zdravilu, niso na voljo.
Reliable methods of contraception include intra-uterine device or a combination of oral contraceptive (also know as the pill) and condoms.
Zanesljive metode kontracepcije vključujeno maternični vložek ali kombinacijo peroralnega kontraceptiva (poznanega tudi kot tabletka) in kondoma.
The blood stem cells can then be collected by a machine that separates blood components (apheresis machine).
Matične celice je nato mogoče odvzeti z napravo, ki ločuje krvne komponente (naprava za aferezo).
Some iron chelators are myelosuppressive.
Nekateri železovi kelati so mielosupresivni.
Do not use an in-line blood filter or an infusion pump.
Ne uporabljajte povezanega filtra za kri ali infuzijske črpalke.
Duration of TI
Trajanje TI
A clear to slightly cloudy, colourless to yellow or pink dispersion.
Bistra do rahlo motna, brezbarvna do rumena ali rožnata disperzija.
Signs of leukaemia and the need to obtain urgent medical care if these signs are present.
Znaki levkemije in potreba po nujni zdravstveni oskrbi, če se pojavijo ti znaki.
• increased concentration of haemoglobin in cells
• povečana koncentracija hemoglobina v celicah
All material that has been in contact with Zynteglo (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Vse materiale, ki so bili v stiku z zdravilom Zynteglo (trdi in tekoči odpadki), je treba obravnavati in odstraniti kot potencialno kužne odpadke v skladu z lokalnimi smernicami za biološko varnost.
• decreased testosterone
• zmanjšana koncentracija testosterona
Overall results
Skupni rezultati
You will be given a Patient Alert Card which contains important safety information that you need to know about your treatment with Zynteglo.
Prejeli boste opozorilno kartico bolnika s pomembnimi varnostnimi informacijami, ki jih morate poznati o zdravljenju z zdravilom Zynteglo.
The added gene from Zynteglo will not be passed on to your children.
Dodani gen iz zdravila Zynteglo se ne bo prenesel na vaše otroke.
The nature of Zynteglo is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Narava zdravila Zynteglo je taka, da konvencionalne študije o farmakokinetiki, absorpciji, porazdelitvi, presnovi in izločanju niso uporabne.
It is made specifically for each patient, using the patient's own (also called autologous) blood stem cells.
Izdelano je posebej za vsakega bolnika iz bolnikovih lastnih (imenovanih tudi avtolognih) krvotvornih matičnih celic.
After carefully removing the outer metal container, thaw each infusion bag at 37°C in a water bath or dry bath for approximately 2-4 minutes.
Po skrbni odstranitvi zunanjega kovinskega vsebnika vsako infuzijsko vrečko v približno 2-4 minutah odtajate pri 37 °C v vodni ali suhi kopeli.
This is equivalent to 20-78% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 2078 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslo osebo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
It is recommended that patients with MRI results demonstrating liver iron content ≥15 mg/g undergo liver biopsy for further evaluation.
Priporočljivo je, da bolniki, pri katerih rezultati MRI kažejo, da je vsebina železa v jetrih ≥ 15 mg/g, opravijo biopsijo jeter za nadaljnjo ocenjevanje.
If you are a woman, you will be given a pregnancy test before starting mobilisation, before you are given chemotherapy, and before Zynteglo treatment in order to confirm that you are not pregnant.
Če ste ženska, boste opravili test nosečnosti pred začetkom mobilizacije, preden prejmete kemoterapijo in pred zdravljenjem z zdravilom Zynteglo, da se zagotovi, da niste noseči.
Any blood products required within the first 3 months after Zynteglo infusion should be irradiated.
Vse krvne izdelke, potrebne v prvih 3 mesecih po infuziji zdravila Zynteglo, je treba obsevati.
• increase of certain enzymes in the blood which may indicate a problem with your liver
• zvišanje določenih encimov v krvi, kar lahko nakazuje na težave z jetri
• have symptoms that could be from internal bleeding, such as unusual stomach or back pain, or severe headache
• imate simptome, ki bi lahko nakazovali na notranje krvavitve, kot so neobičajne bolečine v trebuhu ali hrbtu ali hud glavobol;
• excess acid in the body not removed by the kidneys
• odvečna kislina v telesu, ki jo ledvice ne odstranijo
• transfusion reaction
• reakcija na transfuzijo
Do not leave the medicinal product unattended and do not submerge the infusion ports if thawed in a water bath.
Zdravila ne puščajte brez nadzora in ne potopite infuzijskih odprtin, če za odtajanje uporabljate vodno kopel.
The traceability requirements of cell-based advanced therapy medicinal products must apply.
Upoštevati je treba zahteve glede sledljivosti zdravil za napredno celično zdravljenje.
Blood cell count determination and other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise.
O spremljanju števila krvnih celic in drugih primernih testih je treba razmisliti takrat, kadar klinični simptomi nakazujejo krvavitev.
Irradiation could lead to inactivation of the product.
Obsevanje lahko povzroči inaktivacijo zdravila.
Conventional mutagenicity, carcinogenicity and reproductive and developmental toxicity studies have not been conducted.
Konvencionalne študije mutagenosti, karcinogenosti, reproduktivne in razvojne toksičnosti niso bile izvedene.
(First Infusion Bag)
(Prva infuzijska vrečka)
• numbness and pain in hands and feet
• odrevenelost in bolečine v rokah in nogah
• abnormal blood test results (decrease in magnesium and potassium, too much citrate, or increase in white blood cells)
• nenormalni rezultati krvnega testa (zmanjšanje koncentracije magnezija in kalija, preveč citrata ali povečanje števila belih krvnih celic)
Zynteglo has no influence on the ability to drive or use machines.
Zdravilo Zynteglo nima vpliva na sposobnost vožnje in upravljanja strojev.
QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
KAKOVOSTNA IN KOLIČINSKA SESTAVA Splošen opis
All patients had a Karnofsky performance score ≥80 and the majority had a performance score of 100 at baseline.
Vsi bolniki so imeli stanje zmogljivosti po Karnofskem ≥ 80 in večina je imela status zmogljivosti 100 ob izhodišču.
• low body temperature
• nizka telesna temperatura
Once thawed: maximum 4 hours at room temperature (20°C-25°C).
Po odtajanju: največ 4 ure pri sobni temperaturi (20 °C do 25 °C).
Before treatment with Zynteglo, you will be given medicines know as mobilisation medicine and chemotherapy medicine (see sections 3 and 4 for more information on these medicines, including possible side effects).
Pred zdravljenjem z zdravilom Zynteglo boste prejeli zdravila, poznana kot zdravila za mobilizacijo in zdravila za kemoterapijo (za več informacij o teh zdravilih glejte poglavje 3 in 4, vključno z možnimi neželenimi učinki).
Zynteglo is prepared using parts of the human immunodeficiency virus (HIV), which have been altered so that they cannot cause HIV infection.
Zdravilo Zynteglo je bilo izdelano z uporabo delov virusa humane imunske pomanjkljivosti (HIV), ki so bili spremenjeni tako, da ne morejo povzročiti okužbe z virusom HIV.
All patients completed HGB-204 and HGB-205 and enrolled for long-term follow-up in the LTF-303 study.
Vsi bolniki so zaključili študiji HGB-204 in HGB-205 ter so se vključili v dolgoročno spremljanje v študiji LTF-303.
If the liver biopsy demonstrates bridging fibrosis, cirrhosis, or active hepatitis, HSC transplantation with myeloablative conditioning is not appropriate.
Če biopsija jeter pokaže premostitveno fribrozo, cirozo ali aktivni hepatitis, presaditev HSC z mieloblativnim postopkom ni primerna.
Of the 11 patients followed for at least 6 months after Zynteglo infusion, 6 patients did not restart iron chelation or receive phlebotomy, 3 patients restarted iron chelation, and 2 patients received phlebotomy to reduce iron levels.
Od 11 bolnikov, ki so jih spremljali vsaj 6 mesecev po infuziji zdravila Zynteglo, 6 bolnikov ni ponovno pričelo s kelacijo železa ali prejelo flebotomije, 3 bolniki so ponovno pričeli s kelacijo železa, 2 bolnika pa sta prejela flebotomijo za zmanjšanje ravni železa.
• Zynteglo will only be available through bluebird bio qualified treatment centres to ensure traceability of the patient`s cells and manufactured drug product between the treating hospital and manufacturing site.
• Zdravilo Zynteglo bo na voljo le preko usposobljenih bluebird bio centrov, da se zagotovi sledljivosti bolnikovih celic in izdelanega zdravila med bolnišnico, kjer poteka zdravljenje in mestom izdelave.
Date of Birth (DD/MM/YYYY): Weight at First Collection (kg): Patient ID:
Datum rojstva (DD/MM/LLLL): Telesna masa pri prvem odvzemu (kg): ID bolnika:
Zynteglo can only be made if enough of the right kind of blood stem cells can be collected from your blood (CD34+ blood stem cells).
Zdravilo Zynteglo je mogoče izdelati le v primeru, ko je mogoče odvzeti dovolj pravih krvotvornih matičnih celic iz vaše krvi (krvotvornih matičnih celic CD34)+).
genotype, the MAH should submit interim data and the 5 years follow-up results of Study LTF-303.
mora imetnik dovoljenja za promet predložiti vmesne podatke in rezultate 5letnega spremljanja za študijo LTF-303.
Bars represent interquartile ranges.
Vrstice predstavljajo interkvartilne razpone.
Thawing of each infusion bag takes approximately 2 to 4 minutes.
Za odtajanje vsake infuzijske vrečke boste potrebovali približno 2 do 4 minute.
Failure of neutrophil engraftment is a short-term but potentially severe risk, defined as failure to achieve 3 consecutive absolute neutrophil counts (ANC) ≥500 cells/µL obtained on different days by Day 43 after infusion of
Neuspešna vsaditev nevtrofilcev je kratkotrajno, vendar potencialno zelo nevarno tveganje, definirano kot nezmožnost doseči 3 zaporedne absolutne vrednosti nevtrofilcev (ANC) ≥ 500 celic/µl, pridobljene ob različnih dneh do 43. dneva po infuziji zdravila Zynteglo.
Work surfaces and material which have potentially been in contact with Zynteglo must be decontaminated with a viricidal disinfectant according to the manufacturer's instructions.
Delovne površine in material, ki so lahko bili v stiku z zdravilom Zynteglo, morajo biti dekontaminirani z viricidom v skladu z navodili proizvajalca.
Nevertheless, there is a theoretical risk of leukaemia or lymphoma after treatment with Zynteglo.
Kljub temu obstaja teoretično tveganje za levkemijo ali limfom po zdravljenju z zdravilom Zynteglo.
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (bioloških učinkovin)
For men, this may be sperm or testicular tissue.
Pri moških je to sperma ali tkivo testisov.
• chest pain not due to a heart problem
• bolečina v prsnem košu, ki ni posledica težav s srcem
Following successful engraftment and achievement of transfusion independence, the effects of the product are expected to be life-long.
Po uspešni vsaditvi in doseženi neodvisnosti od transfuzije pri bolniku se pričakuje trajne učinke zdravila.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o vsakem domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
Before treatment with Zynteglo, your doctor will perform tests to make sure your heart and liver are functioning properly so you can be treated safely with Zynteglo.
Pred zdravljenjem z zdravilom Zynteglo bo vaš zdravnik opravil teste, da se prepriča o pravilnem delovanju vašega srca in jeter, da bo zdravljenje z zdravilom Zynteglo za vas varno.
• Thaw Zynteglo at 37°C in a water bath or dry bath.
• Odtajajte zdravilo Zynteglo na 37 °C v vodni kopeli ali suhi kopeli.
The European Medicines Agency has deferred the obligation to submit the results of studies with Zynteglo in one or more subsets of the paediatric population in β-thalassaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zynteglo za eno ali več podskupin pediatrične populacije pri β-talasemiji (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The MAH shall ensure that in each Member State where Zynteglo is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense and/or use Zynteglo have access to/are provided with the following educational package to be disseminated through professional bodies:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer bo zdravilo Zynteglo na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo zdravilo Zynteglo predpisovali, izdajali in/ali uporabljali, imeli dostop/prejeli naslednji paket izobraževalnih gradiv, ki ga bodo razdeljevali strokovni organi:
Local biosafety guidelines applicable for such products should be followed.
Upoštevati je treba lokalne smernice za biološko varnost, ki veljajo za ta zdravila.
What Zynteglo is and what it is used for 2.
Kaj je zdravilo Zynteglo in za kaj ga uporabljamo 2.
The planned dose of G-CSF was 10 µg/kg/day in patients with a spleen, and 5 µg/kg/day in patients without a spleen, given on Days 1 through 5 of mobilisation in the morning.
Načrtovani odmerek G-CSF je bil 10 µg/kg/dan pri bolnikih s vranico in 5 µg/kg/dan pri bolnikih brez vranice, bolniki pa so ga prejeli zjutraj 1. do 5. dan mobilizacije.
Patients should be monitored annually for leukaemia or lymphoma (including with a complete blood count) for 15 years post treatment with Zynteglo.
Bolnike je treba vsako leto spremljati za levkemijo ali limfom (vključno s celotno krvno sliko), in sicer še 15 let po zdravljenju z zdravilom Zynteglo.
Each dose contains 391-1564 mg sodium.
En odmerek vsebuje 391-1564 mg natrija.
It is therefore advised to cryopreserve semen or ova before treatment if possible.
Zato je priporočljivo, da pred zdravljenjem zamrznete spermo ali jajčeca, če je to mogoče.
Why of bags will vary by patient.
Število vrečk se med bolniki razlikuje.
Zynteglo is intended for autologous use (see section 4.4) and should only be administered once.
Zdravilo Zynteglo je namenjeno za avtologno uporabo (glejte poglavje 4.4) in ga je dovoljeno dati samo enkrat.
A pharmacology, biodistribution, toxicity and genotoxicity study was conducted in a mouse model of β-thalassaemia.
Študija farmakologije, biološke porazdelitve, toksičnosti in genotoksičnosti je bila izvedena na mišjem modelu β-talasemije.
The educational and controlled distribution programme is aimed at providing information on the safe use of Zynteglo.
Cilj izobraževalnega pograma in programa nadzorovane distribucije je zagotavljanje informacij o varni uporabi zdravila Zynteglo.
• increase or decrease in blood protein
• povečanje ali zmanjšanje ravni proteinov v krvi
It is recommended that patients maintain haemoglobin (Hb) ≥11 g/dL for 30 days prior to myeloablative conditioning.
Priporočeno je, da bolniki vzdržujejo raven hemoglobina (Hb) ≥ 11 g/dl 30 dni pred mieloablativnim postopkom.
The pharmacology, toxicology and genotoxicity of the BB305 LVV used for transduction in the manufacture of Zynteglo were evaluated in vitro and in vivo.
Farmakologijo, toksikologijo in genotoksičnost BB305 LVV, uporabljenega za prenos pri izdelavi zdravila Zynteglo, so ocenili in vitro in in vivo.
• yellowing of skin and eyes
• porumenelost kože in oči