FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, IgE testing should be repeated if symptoms of rabbit allergy develop.
Slovenian: Poleg tega je treba ponoviti testiranje IgE, če se razvijejo simptomi alergije na kunce:
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an Educational pack.
Slovenian: • imetnik dovoljenja za promet z zdravilom mora zagotoviti, da ob začetku dajanja zdravila v promet vsi zdravstveni delavci, ki naj bi predpisovali zdravilo Ruconest, prejmejo izobraževalno gradivo.
English: • The patient card should include an area where patients can record the results of their last IgE anti Rabbit (dander) and the date of the test
Slovenian: • kartica bolnika mora vsebovati prostor, kjer lahko bolniki zabeležijo rezultate svojega zadnjega testa protiteles IgE proti kunčjemu epiteliju (prhljaju) in datum testa;
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Slovenian: • morebitno tveganje preobčutljivostne reakcije tipa III, povzročene z imunskimi kompleksi, zaradi tvorbe protiteles proti nečistotam, povezanim z gostiteljem (HRI).
English: o Information about the appropriate methodology to be used for laboratory testing of serum IgE antibodies against rabbit epithelium (dander)
Slovenian: o informacije o ustrezni metodologiji, ki se uporablja za laboratorijsko testiranje seruma protiteles IgE proti kunčjemu epiteliju (prhljaju);
English: • That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
Slovenian: • da imajo lahko bolniki s klinično dokazano alergijo na kravje mleko protitelesa, ki povzročijo navzkrižno reakcijo z nečistotami kunčjega mleka v zdravilu Ruconest;
English: • That they are receiving Ruconest for treatment of acute attack of hereditary angioedema
Slovenian: • da prejemajo zdravilo Ruconest za zdravljenje akutnih napadov dednega angioedema;
English: • That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins
Slovenian: • da je zdravilo Ruconest pridobljeno iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin;
English: • a reminder that IgE anti rabbit (dander) testing should be repeated once a year or after 10 treatments, whichever occurs first.
Slovenian: • opomnik, da se mora testiranje na protitelesa IgE proti kunčjemu epiteliju (prhljaju) ponoviti enkrat na leto ali po 10 zdravljenjih, kar je prej.
English: • The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
Slovenian: • dejstva, da se zdravilo Ruconest pridobiva iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin (nečistot, povezanih z gostiteljem, HRI - Host Related Impurities);
English: • That Ruconest is contra indicated in all patients with known or suspected rabbit allergy or with positive serum IgE antibodies against rabbit dander due to the risk of major allergic reactions, therefore:
Slovenian: • da je zdravilo Ruconest kontraindicirano pri vseh bolnikih z znano alergijo na kunce ali sumu nanjo ali s pozitivnim serumom protiteles IgE proti kunčjemu prhljaju zaradi tveganja močnih alergijskih reakcij, zaradi česar:
English: • That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema and should be administered by a health care professional.
Slovenian: • da je treba zdravilo Ruconest uvesti po navodilih in pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem dednega angioedema, ter da mora zdravilo dati zdravstveni delavec;
English: • Copies of the patient card to be given to patients before they receive Ruconest
Slovenian: • izvode kartice za bolnika, ki jo mora bolnik prejeti pred začetkom jemanja zdravila Ruconest.
English: • That they have been tested negative for IgE anti rabbit (dander) within the last year.
Slovenian: • da so bili rezultati testiranja na protitelesa IgE proti kunčjemu epiteliju (prhljaju) v zadnjem letu negativni;
English: Advice about the immunogenicity laboratory testing program for detecting these antibodies for following up suspected immune complex-mediated disease, and about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Slovenian: Nasvet glede laboratorijskega programa testiranja imunogenosti za odkrivanje teh protiteles za spremljanje morebitnih bolezni, povzročenih z imunskimi kompleksi, in glede postopka, ki ga je treba upoštevati pri zbiranju in odpremi vzorca krvi v osrednji laboratorij podjetja.
English: o Before initiating treatment with Ruconest all patients should be tested for the presence of IgE antibodies against rabbit epithelium (dander).
Slovenian: o je treba pred začetkom zdravljenja z zdravilom Ruconest vse bolnike testirati na prisotnost protiteles IgE proti kunčjemu epiteliju (prhljaju).
English: Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Slovenian: Nasvet glede laboratorijskega programa testiranja imunogenosti za ta protitelesa, ki ga zagotovi podjetje za spremljanje morebitnega pojava nevtralizirajočih protiteles, in glede postopka, ki ga je treba upoštevati, za zbiranje in odpremo vzorca krvi v osrednji laboratorij podjetja.
English: • Summary of Product Characteristics and Patient Information Leaflet for Ruconest
Slovenian: • povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Ruconest,
English: Only patients who have been shown to have negative test results should be treated with Ruconest.
Slovenian: Z zdravilom Ruconest se sme zdraviti samo bolnike z negativnimi rezultati testa.
English: There were three treatment studies and one prevention study.
Slovenian: Izvedli so tri študije zdravljenja in eno študijo preventivnega zdravljenja.
English: Most of the patients in these two studies were infected with human immunodeficiency virus (HIV).
Slovenian: Večina bolnikov v teh dveh študijah je bila okuženih z virusom humane imunske pomanjkljivosti (HIV).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycamine on 25 April 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Mycamine, veljavno po vsej Evropski uniji, odobrila dne 25. aprila 2008.
English: This checklist will remind prescribers how to use the medicine safely.
Slovenian: Ta seznam bo predpisovalce zdravila opominjal, kako zdravilo varno uporabljati.
English: Mycamine is used in babies, children and adults in the following situations:
Slovenian: Zdravilo Mycamine se uporablja pri dojenčkih, otrocih in odraslih v naslednjih primerih:
English: Mycamine is given once a day as an infusion lasting around one hour.
Slovenian: Zdravilo Mycamine se daje enkrat dnevno kot infuzija, ki traja približno eno uro.
English: What measures are being taken to ensure the safe use of Mycamine?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Mycamine ?
English: It works by interfering with the production of an essential component of the fungal cell wall called 1,3 β D glucan.
Slovenian: Deluje tako, da vpliva na tvorbo osnovne komponente celične stene glive, imenovane 1,3-β-D-glukan.
English: Fungal cells treated with Mycamine have incomplete or defective cell walls, making them fragile and unable to grow.
Slovenian: Celice gliv, ki so izpostavljene zdravilu Mycamine, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
English: The main measure of effectiveness was the number of patients who did not develop a fungal infection during treatment or the following four weeks.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se ni razvila glivična okužba med samim zdravljenjem ali v naslednjih štirih tednih.
English: The company that makes Mycamine will ensure that prescribers in all Member States receive a checklist before the launch of the medicine.
Slovenian: Družba, ki proizvaja zdravilo Mycamine, bo zagotovila, da bodo predpisovalci zdravila v vseh državah članicah še pred pričetkom trženja zdravila prejeli kontrolni seznam ob predpisovanju.
English: Mycamine should only be used after careful assessment of its risks and benefits, particularly in patients who have existing liver problems.
Slovenian: Zdravilo Mycamine je treba uporabljati izključno na podlagi skrbne ocene njegovih tveganj in koristi, zlasti pri bolnikih z obstoječimi težavami z jetri.
English: In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment.
Slovenian: V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih je bilo zdravljenje uspešno, kar se je pokazalo v obliki izboljšanja simptomov in izkoreninjenja glive ob koncu zdravljenja.
English: The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines.
Slovenian: Učinkovitost zdravila Mycamine so preučevali v štirih glavnih študijah, v katerih so ga primerjali z drugimi protiglivičnimi zdravili.
English: EPAR summary for the public micafungin
Slovenian: Povzetek EPAR za javnost mikafungin
English: This is a summary of the European public assessment report (EPAR) for Mycamine.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mycamine.
English: What benefit has Mycamine shown during the studies?
Slovenian: Kakšne koristi je zdravilo Mycamine izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mycamine.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mycamine, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about Mycamine
Slovenian: Druge informacije o zdravilu Mycamine:
English: The dose depends on what it is being used for, the patient's weight, and the response to treatment.
Slovenian: Odmerek je odvisen od namena, bolnikove telesne mase in odziva na zdravljenje.
English: The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
Slovenian: Najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih od 100 bolnikov) so levkopenija (nizka raven levkocitov, vrste belih krvničk), nevtropenija (nizka raven nevtrofilov, vrste belih krvničk), anemija (nizka raven rdečih krvničk), hipokaliemija (nizka raven kalija v krvi), hipomagneziemija (nizka raven magnezija v krvi), hipokalciemija (nizka raven kalcija v krvi), glavobol, flebitis (vnetje ven), navzeja (slabost), bruhanje, driska, bolečine v trebuhu, znaki težav z jetri v krvi (povečane ravni alkalne fosfataze, aspartat-aminotransferaze, alanin-aminotransferaze ali bilirubina), izpuščaj, pireksija (povišana telesna temperature) in tresenje.
English: It contains the active substance micafungin.
Slovenian: Vsebuje zdravilno učinkovino mikafungin.
English: What is the risk associated with Mycamine?
Slovenian: Kakšna tveganja so povezana z zdravilom Mycamine?
English: In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Slovenian: V dveh študijah kandidoze požiralnika je bilo okrog 90 % bolnikov uspešno zdravljenih z zdravilom Mycamine, flukonazolom ali kaspofunginom.
English: Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
Slovenian: Uporaba zdravila Mycamine ni priporočljiva pri bolnikih, ki imajo hude težave z jetri, dolgotrajno bolezen jeter ali ki prejemajo druga zdravila, ki bi lahko škodovala jetrom ali DNA.
English: Treatment with Mycamine should be initiated by a doctor who has experience managing fungal infections, and after considering official or national guidance on the use of antifungal medicines.
Slovenian: Zdravljenje z zdravilom Mycamine mora uvesti zdravnik z izkušnjami pri zdravljenju glivičnih okužb ob upoštevanju uradnih oziroma nacionalnih smernic za uporabo protiglivičnih zdravil.
English: The CHMP decided that Mycamine's benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days.
Slovenian: CHMP je zaključil, da so koristi zdravila Mycamine večje od z njim povezanih tveganj za zdravljenje invazivne kandidoze in kandidoze požiralnika ter za preprečevanje okužbe s Candido pri bolnikih po alogenski presaditvi hematopoetskih matičnih celic ali pri bolnikih, za katere predvidevajo, da bodo imeli 10- ali večdnevno nevtropenijo.
English: Because of a possible risk of liver tumours, Mycamine is only to be used if other antifungal medicines are not appropriate.
Slovenian: Zaradi morebitne nevarnosti razvoja jetrnih tumorjev naj bi se zdravilo Mycamine uporabljalo le, če druga protiglivična zdravila niso primerna.
English: The list of fungi against which Mycamine is active can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Za seznam glivic, proti katerim deluje zdravilo Mycamine, glejte povzetek glavnih značilnosti zdravila (ki je tudi del EPAR).
English: For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in a study involving 531 adults and 106 children, including newborns and premature babies.
Slovenian: Pri zdravljenju invazivne kandidoze so zdravilo Mycamine primerjali z amfotericinom B v študiji, v katero je bilo vključenih 531 odraslih in 106 otrok, vključno z novorojenčki in nedonošenčki.
English: Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
Slovenian: Dodatni pogosti neželeni učinki pri otrocih (opaženi pri 1 do 10 otrocih od 100 otrok) so trombocitopenija (nizka raven krvnih ploščic), tahikardija (hitro utripanje srca), hipertenzija (visok krvni tlak), hipotenzija (nizek krvni tlak), hepatomegalija (povečana jetra), akutna ledvična odpoved in povečane ravni sečnine v krvi.
English: The active substance in Mycamine, micafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Slovenian: Zdravilna učinkovina zdravila Mycamine, mikafungin, je protiglivično zdravilo, ki spada v skupino ehinokandinov.
English: • to prevent infection with Candida in patients who are having a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
Slovenian: • za preprečevanje okužbe z glivo Candida pri bolnikih pred presaditvijo kostnega mozga ali pri bolnikih, za katere predvidevajo, da bodo 10 ali več dni imeli nevtropenijo (nizko raven nevtrofilcev, vrste belih krvničk).
English: Why has Mycamine been approved?
Slovenian: Zakaj je bilo zdravilo Mycamine odobreno?
English: However due to a possible risk of liver tumour, based on results seen in rats, the Committee recommended that Mycamine should only be used if other antifungal medicines are not appropriate.
Slovenian: Vendar je Odbor zaradi morebitne nevarnosti jetrnega tumorja glede na izide študij s podganami priporočil uporabo zdravila Mycamine le, če ni drugih primernih protiglivičnih zdravil.
English: The full EPAR for Mycamine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mycamine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Za več informacij o zdravljenju z zdravilom Mycamine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: When Mycamine is used to prevent Candida infection, treatment should continue for one week after white blood cell counts have recovered.
Slovenian: Ko se zdravilo Mycamine uporablja za preprečevanje okužbe s Candido, mora zdravljenje trajati še en teden po vzpostavitvi normalnih vrednosti belih krvničk.
English: For the full list of all side effects reported with Mycamine, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mycamine, glejte navodilo za uporabo.
English: For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in a study involving 518 adults, and with caspofungin in another study involving 452 adults.
Slovenian: Pri zdravljenju kandidoze požiralnika so zdravilo Mycamine primerjali s flukonazolom v študiji, v katero je bilo vključenih 518 odraslih, ter s kaspofunginom v drugi študiji, v katero je bilo vključenih 452 odraslih.
English: Mycamine should not be used in people who may be hypersensitive (allergic) to micafungin, other echinocandins, or any of the other ingredients.
Slovenian: Zdravila Mycamine ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) mikafungin ali katero koli drugo sestavino zdravila.
English: Mycamine is also used to treat candidiasis in the oesophagus (gullet) in patients over 16 years of age for whom intravenous treatment is suitable.
Slovenian: Zdravilo Mycamine se prav tako uporablja pri zdravljenju kandidoze požiralnika pri bolnikih, starejših od 16 let, za katere je intravensko zdravljenje primerno.
English: Patients being treated for invasive candidiasis should receive Mycamine for at least two weeks, and for a week after symptoms have resolved and there are no signs of fungus in the blood.
Slovenian: Bolniki, ki se zdravijo zaradi invazivne kandidoze, morajo zdravilo Mycamine prejemati najmanj dva tedna ter en teden po tem, ko simptomi izginejo in v krvi ni več znakov glivic.
English: Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein).
Slovenian: Zdravilo Mycamine je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Because liver damage and tumours have been seen in rats receiving Mycamine for long periods, patients should be monitored for liver problems during Mycamine treatment using blood tests.
Slovenian: Ker so pri podganah, ki so daljše obdobje prejemale zdravilo Mycamine, opazili poškodbe jeter in tumorje, je treba med zdravljenjem z zdravilom Mycamine bolnike spremljati s krvnimi testi zaradi morebitnih težav z jetri.
English: Treatment should be stopped if there are persistent increases in liver enzymes.
Slovenian: V primeru trajnega povišanja jetrnih encimov je treba zdravljenje ustaviti.
English: For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant.
Slovenian: Pri preprečevanju kandidoze so zdravilo Mycamine primerjali s flukonazolom pri 889 odraslih in otrocih po presaditvi kostnega mozga.
English: Mycamine was as effective as the comparator medicines in the treatment of candidiasis.
Slovenian: Zdravilo Mycamine se je pri zdravljenju kandidoze izkazalo za enako učinkovito kot primerjalna zdravila.
English: Patients being treated for oesophageal candidiasis should continue to receive Mycamine for at least one week after symptoms have resolved.
Slovenian: Bolniki, ki se zdravijo zaradi kandidoze požiralnika, morajo zdravilo Mycamine prejemati še najmanj teden dni po prenehanju simptomov.
English: In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated.
Slovenian: V študiji invazivne kandidoze je bilo uspešno zdravljenih 90 % odraslih, ki so prejemali bodisi zdravilo Mycamine bodisi amfotericin B. Podobni rezultati so bili ugotovljeni pri otrocih.
English: Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant: 80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
Slovenian: Zdravilo Mycamine je bilo učinkovitejše od flukonazola pri preprečevanju glivične okužbe pri bolnikih, ki so prestali presaditev kostnega mozga: pri 80 % bolnikov (340 od 425), ki so prejemali zdravilo
English: How has Mycamine been studied?
Slovenian: Kako je bilo zdravilo Mycamine raziskano?
English: What is Mycamine used for?
Slovenian: Za kaj se uporablja zdravilo Mycamine?
English: How does Mycamine work?
Slovenian: Kako zdravilo Mycamine deluje?
English: How is Mycamine used?
Slovenian: Kako se zdravilo Mycamine uporablja?
English: • to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called
Slovenian: • za zdravljenje invazivne kandidoze (vrste glivične okužbe, ki jo povzroča kvasovkam podobna gliva, imenovana Candida); „invazivna“ pomeni, da se je gliva razširila v tkivo in krvne žile;
English: What is Mycamine?
Slovenian: Kaj je zdravilo Mycamine?
English: EU/1/18/1310/001
Slovenian: EU/1/18/1310/001 Deferipron Lipomed
English: Blister (aluminium/PVC/PVDC)
Slovenian: 500 mg filmsko obložena tableta peroralna uporaba pretisni omot (alu/PVC/PVDC)
English: Oral use
Slovenian: Jakost
English: 2 tubes 12 tubes 20 tubes 40 tubes
Slovenian: 2 tubi 12 tub 20 tub 40 tub
English: Repeat the administration after 7 days.
Slovenian: Dajanje ponovite po 7 dneh.
English: EU/2/14/170/0001 (2 tubes) EU/2/14/170/0002 (12 tubes) EU/2/14/170/0003 (20 tubes) EU/2/14/170/0004 (40 tubes)
Slovenian: EU/2/14/170/0001 (2 tubi) EU/2/14/170/0002 (12 tub) EU/2/14/170/0003 (20 tub) EU/2/14/170/0004 (40 tub)
English: Instructions for proper use:
Slovenian: Navodila za pravilno uporabo:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/07/2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 31/07/2014
English: 1 mg For the full list of excipients, see section 6.1.
Slovenian: 1 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: ATC-vet code: QS02CA90.
Slovenian: Oznaka ATC vet: QS02CA90
English: These findings were not associated with clinical signs.
Slovenian: Ta opažanja niso bila povezana s kliničnimi znaki.
English: Do not use in dogs with generalised demodicosis.
Slovenian: Ne uporabite pri psih z generalizirano demodikozo.
English: To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Slovenian: Da bi se lastniki izognili temu tveganju, se priporoča, da se to zdravilo za uporabo v veterinarski medicini daje samo s strani veterinarja ali pod njegovim strogim nadzorom.