FrancophonIA/ELRC3.0 huggingface dataset:
English: • prevent ‘skeletal events' (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Slovenian: • preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti);
English: This means that Ibandronic acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU).
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ibandronic acid Accord has been shown to be comparable to Bondronat and Bonviva.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Ibandronska kislina Accord primerljivo z zdraviloma Bondronat in Bonviva.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicines, Bondronat and Bonviva, and do not need to be repeated for Ibandronic acid Accord.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnima zdraviloma Bondronat in Bonviva, zato jih ni treba ponoviti za zdravilo Ibandronska kislina Accord.
English: The full EPAR for the reference medicines can also be found on the Agency's website.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za referenčno zdravilo je tudi na voljo na spletni strani agencije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic acid Accord on 19 November 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ibandronska kislina Accord, veljavno po vsej Evropski uniji, izdala 19. novembra 2012.
English: For the prevention of skeletal events or the treatment of hypercalcaemia in cancer patients, treatment with this medicine should only be started by a doctor who has experience in the treatment of cancer.
Slovenian: Zdravljenje s tem zdravilom za preprečevanje z okostjem povezanih dogodkov ali zdravljenje hiperkalciemije pri bolnikih z rakom lahko uvede samo zdravnik, ki ima izkušnje z zdravljenjem raka.
English: The reduction of bone loss helps to make bones less likely to break in cancer patients with bone metastases and in women with osteoporosis.
Slovenian: Zmanjšanje izgube kostne mase pripomore k manjši verjetnosti zlomov kosti pri bolnikih z rakom in metastazami v kosteh ter ženskah z osteoporozo.
English: This is a summary of the European public assessment report (EPAR) for Ibandronic acid Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibandronska kislina Accord.
English: As for every medicine, the company provided studies on the quality of Ibandronic acid Accord.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ibandronska kislina Accord.
English: Because Ibandronic acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Slovenian: Ker je zdravilo Ibandronska kislina Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: • treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Slovenian: • zdravljenje tumorsko povzročene hiperkalciemije (visokih ravni kalcija v krvi).
English: What measures are being taken to ensure the safe and effective use of Ibandronic acid Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ibandronska kislina Accord?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibandronic acid Accord have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ibandronska kislina Accord upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Slovenian: Osteonekroza čeljusti je obolenje, ki prizadene čeljustne kosti in povzroči bolečine, oteklost v ustih in majanje zob.
English: For more information about treatment with Ibandronic acid Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ibandronska kislina Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The full EPAR for Ibandronic acid Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients with moderate or severe kidney problems should receive Ibandronic acid Accord infusions at a lower dose over an hour.
Slovenian: Bolniki z zmernimi ali hudimi težavami z ledvicami morajo prejeti nižji odmerek infuzij zdravila Ibandronska kislina Accord, te pa morajo trajati več kot eno uro.
English: The Agency recommended that Ibandronic acid Accord be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo Ibandronska kislina Accord odobri za uporabo v EU.
English: Therefore, the Agency's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da enako kot pri zdravilih Bondronat in Bonviva koristi odtehtajo znana tveganja.
English: This is because Ibandronic acid Accord is given by infusion or injection into a vein, so the active substance is delivered straight into the bloodstream.
Slovenian: Razlog za to je dejstvo, da se zdravilo Ibandronska kislina Accord daje z infundiranjem ali injiciranjem v veno, zaradi česar zdravilna učinkovina vstopi neposredno v krvni obtok.
English: In the treatment of hypercalcaemia caused by tumours, Ibandronic acid Accord is given into a vein as an infusion of 2 or 4 mg, depending on how severe the hypercalcaemia is.
Slovenian: Pri zdravljenju tumorsko povzročene hiperkalciemije se zdravilo Ibandronska kislina Accord daje z infundiranjem v veno v odmerku 2 ali 4 mg, odvisno od resnosti hiperkalciemije.
English: Ibandronic acid Accord is available as a solution for injection (3 mg) in a pre-filled syringe and as a concentrate (2 mg and 6 mg) to be made up into a solution for infusion (drip) into a vein.
Slovenian: Ibandronska kislina Accord je na voljo kot raztopina za injiciranje (3 mg) v napolnjeni injekcijski brizgi in kot koncentrat (2 mg in 6 mg) za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: There was no need for ‘bioequivalence' studies to investigate whether Ibandronic acid Accord is absorbed similarly to the reference medicines to produce the same level of the active substance in the blood.
Slovenian: Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Ibandronska kislina Accord absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
English: What are the benefits and risks of Ibandronic acid Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ibandronska kislina Accord?
English: For the treatment of osteoporosis, Ibandronic acid Accord is given as an injection into a vein once every three months.
Slovenian: Za zdravljenje osteoporoze se zdravilo Ibandronska kislina Accord daje z injiciranjem v veno vsake tri mesece.
English: Ibandronic acid Accord is a medicine used to treat certain conditions affecting bones and blood calcium.
Slovenian: Ibandronska kislina Accord je zdravilo, ki se uporablja za zdravljenje določenih obolenj, ki prizadenejo kosti in raven kalcija v krvi.
English: It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Slovenian: Ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva, s čimer se zmanjša izguba kostne mase.
English: Other information about Ibandronic acid Accord
Slovenian: Druge informacije o zdravilu Ibandronska kislina Accord
English: Ibandronic acid Accord contains the active substance ibandronic acid and is a ‘generic medicine'.
Slovenian: Zdravilo Ibandronska kislina Accord vsebuje zdravilno učinkovino ibandronsko kislino in je „generično zdravilo“.
English: The company that markets Ibandronic acid Accord will provide a card to inform patients receiving Ibandronic acid Accord infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Slovenian: Družba, ki trži zdravilo Ibandronska kislina Accord, bo pripravila kartico, s katero bo bolnike, ki prejemajo infuzije tega zdravila, seznanila s tveganjem pojava osteonekroze čeljusti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
English: For practical information about using Ibandronic acid Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ibandronska kislina Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Ibandronic acid Accord is given into a vein as a 6 mg infusion lasting at least 15 minutes every three to four weeks.
Slovenian: Pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh se zdravilo daje vsake tri do štiri tedne kot infuzija v veno v odmerku 6 mg, ki se infundira vsaj 15 minut.
English: Ibandronic acid Accord solution for injection is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Slovenian: Zdravilo Ibandronska kislina Accord v obliki raztopine za injiciranje se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
English: What is Ibandronic acid Accord and what is it used for?
Slovenian: Kaj je zdravilo Ibandronska kislina Accord in za kaj se uporablja?
English: By preventing the breakdown of bones, Ibandronic acid Accord also helps to reduce the amount of calcium released into the blood.
Slovenian: Zdravilo Ibandronska kislina Accord s preprečevanjem razgradnje kosti prav tako pripomore k znižanju ravni kalcija, ki se sprošča v kri.
English: The active substance in Ibandronic acid Accord, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina v zdravilu Ibandronska kislina Accord, ibandronska kislina, je difosfonat.
English: Why is Ibandronic acid Accord approved?
Slovenian: Zakaj je bilo zdravilo Ibandronska kislina Accord odobreno?
English: Ibandronic acid Accord ibandronic acid
Slovenian: Ibandronska kislina Accord ibandronska kislina
English: How does Ibandronic acid Accord work?
Slovenian: Kako zdravilo Ibandronska kislina Accord deluje?
English: How is Ibandronic acid Accord used?
Slovenian: Kako se zdravilo Ibandronska kislina Accord uporablja?
English: How has Ibandronic acid Accord been studied?
Slovenian: Kako je bilo zdravilo Ibandronska kislina Accord raziskano?
English: Ibandronic acid Accord concentrate for solution for infusion (drip) is used in adults to:
Slovenian: Zdravilo Ibandrobska kislina Accord v obliki koncentrata za pripravo raztopine za infundiranje (2 mg in 6 mg) se uporablja pri odraslih za:
English: It is not intended to provide practical advice on how to use Ibandronic acid Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Another approximately 4 % had a transient decrease below the lower limit of normal.
Slovenian: Dodatni približno 4 % so imeli prehodno zmanjšanje pod spodnjo mejo normale.
English: < 12 g/dl after 4 weeks of dose reduction
Slovenian: < 12 g/dl po 4 tednih zmanjševanja odmerka
English: Biopartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
Slovenian: Biopartners GmbH Kaiserpassage 11 D-72764 Reutlingen Nemčija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 April 2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06. april 2010
English: • are older than 65 years or if you have problems with your kidneys.
Slovenian: • če ste starejši od 65 let ali če imate težave z ledvicami,
English: You should tell your doctor if you or your child you are caring for:
Slovenian: Zdravniku morate povedati, če ste vi ali vaš otrok, za katerega skrbite:
English: You should tell your doctor if you have suffered from any other serious illness in the past.
Slovenian: Svojemu zdravniku povejte, če ste v preteklosti resno oboleli za katero drugo boleznijo.
English: Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Slovenian: Na podlagi izsledkov kliničnih preskušanj je priporočljivo zdraviti bolnike vsaj šest mesecev.
English: In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Slovenian: Kar zadeva aktivnost bolezni, se je pri približno eni tretjini bolnikov s stalnim odzivom pokazalo izboljšanje, pri nobenem od bolnikov pa ni prišlo do poslabšanja.
English: Duration of treatment in children and adolescents • Genotype 2 or 3: The recommended duration of treatment is 24 weeks.
Slovenian: Dolžina zdravljenja pri otrocih in mladostnikih • Genotip 2 ali 3: Priporočena dolžina zdravljenja je 24 tednov.
English: Some children did not reach their projected height within 1-5 years after completing treatment.
Slovenian: Nekateri otroci tudi niso dosegli pričakovane telesne višine v obdobju 1 do 5 let po zaključku
English: - Pregnant women (see sections 4.4, 4.6 and 5.3).
Slovenian: − noseče ženske (glejte poglavja 4.4, 4.6 in 5.3).
English: EU/1/10/626/001 (84 film-coated tablets) EU/1/10/626/002 (112 film-coated tablets) EU/1/10/626/003 (140 film-coated tablets) EU/1/10/626/004 (168 film-coated tablets)
Slovenian: EU/1/10/626/001 (84 filmsko obloženih tablet) EU/1/10/626/002 (112 filmsko obloženih tablet) EU/1/10/626/003 (140 filmsko obloženih tablet) EU/1/10/626/004 (168 filmsko obloženih tablet)
English: Packs of 84, 112, 140 and 168 film-coated tablets.
Slovenian: Pakiranja po 84, 112, 140 in 168 filmsko obloženih tablet
English: Please refer also to the relevant product information for antiretroviral medicinal products.
Slovenian: Preberite tudi ustrezne informacije o zdravilu za antiretrovirusna zdravila.
English: Do not have sex with a pregnant woman unless you use a condom.
Slovenian: ne smete imeti spolnih odnosov z nosečnico, če ne uporabljate kondoma.
English: Reminder: If the child is under the age of 3 years, do not administer.
Slovenian: Opomba: Če je otrok star manj kot 3 leta, mu zdravila ne dajajte.
English: Discontinue combination therapy when the below test value is reported:** < 8.5 g/dl
Slovenian: Prekinite kombinirano zdravljenje, če poročajo o spodnjih vrednostih testov ** < 8,5 g/dl
English: Reminder: If your doctor's instructions are different from the amounts in the below table,
Slovenian: Opomba: Če se navodila vašega zdravnika razlikujejo od količin, ki so navedene v spodnji preglednici, upoštevajte zdravnikova navodila.
English: The incidence and severity of teratogenic effects increased with escalation of the dose.
Slovenian: Incidenca in jakost teratogenih učinkov sta se povečevali z večanjem odmerka.
English: Children 3 years of age and older and adolescents:
Slovenian: Otroci, stari tri leta in več in mladostniki:
English: Do not take more than the recommended dosage and take the medicine for as long as prescribed.
Slovenian: Ne prekoračite predpisanega odmerka in zdravilo jemljite tako dolgo kot vam je predpisal zdravnik.
English: - Depending upon the results of these tests, your doctor may change/adjust the number of tablets you or the child you are caring for take, prescribe a different pack size of Ribavirin BioPartners, and/or change the length of time to take this treatment.
Slovenian: - Glede na izvide teh preiskav bo lahko spremenil/prilagodil število tablet, ki jih vi ali otrok, za katerega skrbite, jemljeta in vam predpisal drugo velikost pakiranja zdravila Ribavirin BioPartners in/ali spremenil dolžino zdravljenja.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Slovenian: Kadarkoli je mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zavoro rasti.
English: - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Slovenian: − hude obstoječe srčne bolezni v anamnezi, vključno z nestabilno ali nenadzorovano srčno boleznijo v preteklih šestih mesecih (glejte poglavje 4.4);
English: If it gets worse, your doctor will decide whether or not your Ribavirin BioPartners treatment needs to be changed.
Slovenian: Če se poslabša, se bo vaš zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Ribavirin BioPartners ali ne.
English: - Blood tests will be done regularly to help your doctor to know if this treatment is working.
Slovenian: - Redno boste opravljali krvne preiskave, da bo zdravnik ugotovil, ali je zdravljenje pri vas
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Slovenian: Poleg tega so bile pri 98 % bolnikov (51/52), ki so imeli normalne vrednosti ALT v 24. tednu spremljanja, ob njihovem zadnjem obisku ohranjene
English: The MAH must ensure that the system of pharmacovigilance, as described in version 5 dated 27 April 2009 presented in Module 1.8.2 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 5 z dne 27. aprila 2009 in predložen v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in ves čas trženja
English: You or your female partner must use an effective contraceptive during the time you are taking Ribavirin BioPartners and for 7 months after stopping treatment.
Slovenian: Vi ali vaša partnerka morata uporabljati učinkovito kontracepcijo v času, ko uporabljate zdravilo Ribavirin BioPartners in še 7 mesecev po koncu zdravljenja.
English: This will lessen the possibility for ribavirin to be left in the woman's body.
Slovenian: S tem se zmanjša možnost vnosa ribavirina v žensko telo.
English: Nucleoside analogs: Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Slovenian: Nukleozidni analogi: Uporaba nukleozidnih analogov, samih ali v kombinaciji z drugimi nukleozidi, je povzročila laktacidozo.
English: Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Slovenian: Anemija se pojavi kmalu po začetku dajanja zdravila, vendar je hitro reverzibilna po koncu zdravljenja.
English: This should be discussed with your doctor (see section “Do not take Ribavirin BioPartners”).
Slovenian: O tem se posvetujte s svojim zdravnikom (glejte poglavje „Ne uporabljajte zdravila Ribavirin BioPartners“).
English: The attempt to harm yourself has also been reported in adults, children, and adolescents.
Slovenian: O poskusih samopoškodovanja so poročali pri odraslih, otrocih in mladostnikih.
English: Sustained response was assessed by the response rate six months
Slovenian: Trajni virološki odziv so ocenjevali na podlagi odziva šest mesecev
English: Adults: ≥ 12 g/dl (females); ≥ 13 g/dl (males) Children and adolescents: ≥ 11 g/dl (females); ≥ 12 g/dl (males)
Slovenian: Odrasli: ≥ 12 g/dl (ženske); ≥ 13 g/dl (moški) Otroci in mladostniki ≥ 11 g/dl (ženske); ≥ 12 g/dl (moški)
English: The majority of adverse reactions reported in the study were mild or moderate in severity.
Slovenian: Neželeni učinki, prijavljenih v tej študiji, so bili po jakosti večinoma blagi ali zmerni.
English: If you have any questions about the dose, ask your doctor.
Slovenian: Če imate kakršnakoli vprašanja glede odmerka, se posvetujte s svojim zdravnikom.
English: If any of the following apply to you or your child you are caring for, do not take Ribavirin BioPartners, and tell your doctor if you:
Slovenian: Če karkoli od navedenega velja za vas ali vašega otroka, za katerega skrbite, ne jemljite zdravila Ribavirin BioPartners in povejte svojemu zdravniku:
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Slovenian: Vloga temelji na referenčnem zdravilu za katereganiso niso bile ugotovljene varnostna vprašanja, ki bi zahtevale dodatne aktivnosti za zmanjšanje tveganja.
English: At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Slovenian: Ob koncu obdobja okrevanja so bile spremembe na tibialni in femoralni kosti minimalne, čeprav so bile na splošno statistično značilne v primerjavi s kontrolno skupino samcev pri vseh velikostih odmerka ter pri samicah, ki so prejemale dva največja odmerka v primerjavi s kontrolno skupino.
English: The PSUR submission schedule should follow the PSUR schedule for the reference medicinal product.
Slovenian: Časovnica za predložitev PSUR mora slediti časovnici oddajanja PSUR za referenčno zdravilo.
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Slovenian: Vrednost HCV-RNA morate med zdravljenjem meriti periodično (glejte poglavje 4.2).
English: Ribavirin BioPartners can be very damaging to your unborn baby (embryo).
Slovenian: Zdravilo Ribavirin BioPartners lahko močno škoduje vašemu nerojenemu otroku (embriu)
English: If you take more Ribavirin BioPartners than you should Tell your doctor or pharmacist as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Ribavirin BioPartners, kot bi smeli Obvestite svoje zdravnika ali farmacevta takoj, ko bo to mogoče.
English: do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Slovenian: Zato ne vozite avtomobila in ne upravljajte z orodji ali stroji, če zaradi tega zdravljenja postanete utrujeni, zaspani ali zmedeni.
English: Caution should be exercised when both medicines are co-administered.
Slovenian: Pri sočasni uporabi obeh zdravil je torej potrebna previdnost.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Slovenian: Bolniki naj si temeljito ščetkajo zobe dvakrat na dan in redno hodijo na preglede k zobozdravniku.
English: 3 tablets a
Slovenian: 3 tabletea
English: Children and adolescents weighing less than 47 kg: The use of Ribavirin BioPartners tablets is not recommended.
Slovenian: Otroci in mladostniki s telesno maso pod 47 kg: Uporaba zdravila Ribavirin BioPartners tablet ni priporočljiva.
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Slovenian: Pri vsakem bolniku, ki toži zaradi poslabšanja vida ali o izgubi vida, je treba nemudoma opraviti celoten pregled oči.
English: Case by case benefit/risk assessment in children:
Slovenian: Individualna ocena razmerja med koristmi in tveganji pri otrocih: