natgillin/translations-raw huggingface dataset:
Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating. 
Dicural filmsko obložene tablete vsbujejo difloksacinijev klorid.
Measuring lines indicate the volume supplied. 
Na njej so oznake za določanje volumna.
Skilarence is available as tablets (30 and 120 mg). 
Zdravilo Skilarence je na voljo v obliki tablet (30 mg in 120 mg).
The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity. 
Glavno merilo učinkovitosti je bil delež bolnikov, ki so dosegli 75-odstotno zmanjšanje rezultata resnosti bolezni.
What measures are being taken to ensure the safe and effective use of Skilarence? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Skilarence?
The full EPAR for Skilarence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Skilarence je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Psoriasis results from over-activity of the body's immune (defence) system. 
Psoriaza je posledica čezmerne aktivnosti telesnega imunskega (obrambnega) sistema.
Tablets should be swallowed whole during or immediately after a meal. 
Tablete je treba pogoltniti cele med obrokom ali takoj po njem.
This is a summary of the European public assessment report (EPAR) for Skilarence. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Skilarence.
Most side effects are mild or moderate. 
Večina neželenih učinkov je bila blaga ali zmerna.
Other information about Skilarence 
Druge informacije o zdravilu Skilarence
The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day. 
Začetni odmerek je 30 mg enkrat dnevno, odmerek pa se povečuje vsak teden po urniku, prikazanem v navodilu za uporabo, dokler se stanje psoriaze ne začne izboljševati oziroma dokler bolnik ne prejema največjega odmerka 240 mg trikrat dnevno.
It must also not be used by women during pregnancy or if breast-feeding. 
Prav tako ga ne smejo uporabljati nosečnice ali doječe matere.
It is not intended to provide practical advice on how to use Skilarence. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm . 
Po 16 tednih zdravljenja je takšno zmanjšanje doseglo 37 % bolnikov, ki so jemali zdravilo Skilarence, v primerjavi s 15 % bolnikov, ki so jemali placebo, in 40 % bolnikov, ki so jemali zdravilo Fumaderm.
The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use. 
Odbor CHMP je presodil, da je glavna študija dokazala kratkotrajno učinkovitost zdravila Skilarence, objavljene študije s podobnimi zdravili pa kažejo, da se učinkovitost z nadaljnjo uporabo ohranja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Skilarence večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk. 
Družba, ki trži zdravilo Skilarence, bo zdravstvenim delavcem priskrbela izobraževalno gradivo o tveganju za resne okužbe, vključno s PML, in o zmanjševanju tega tveganja.
Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary. 
Ker zdravilo Skilarence zavira delovanje imunskega sistema, obstaja tveganje za resne okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML; okužbo možganov), vendar se tveganje lahko zmanjša z rednimi preiskavami števila belih krvnih celic in prekinitvijo zdravljenja, če je potrebno.
What benefits of Skilarence have been shown in studies? 
Kakšne koristi je zdravilo Skilarence izkazalo v študijah?
What is Skilarence and what is it used for? 
Kaj je zdravilo Skilarence in za kaj se uporablja?
It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough. 
Uporablja se pri bolnikih z zmerno ali resno obliko bolezni, pri katerih zdravila za neposredni nanos na kožo niso dovolj učinkovita.
It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis. 
Delovala naj bi na celice T (vrsto belih krvnih celic, ki so del imunskega sistema) in preprečila nastajanje snovi, ki povzročajo vnetje in privedejo do psoriaze.
What are the risks associated with Skilarence? 
Kakšna tveganja so povezana z zdravilom Skilarence?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Skilarence upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Skilarence approved? 
Zakaj je bilo zdravilo Skilarence odobreno?
A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate). 
V glavni študiji, ki je vključevala 704 bolnike z zmerno do hudo psoriazo v plakih, so ugotovili, da je zdravilo Skilarence pri zdravljenju bolezni učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in enako učinkovito kot zdravilo Fumaderm (zdravilo za psoriazo, ki vsebuje dimetilfumarat in monoetilfumarat).
Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches. 
Skilarence je zdravilo, ki se uporablja za zdravljenje psoriaze v plakih, bolezni, ki povzroča odebeljena, rdeča in vneta področja na koži z luskastimi zaplatami.
The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general. 
Najpogostejši neželeni učinki zdravila Skilarence (ki se lahko pojavijo pri več kot 1 bolniku od 10) so učinki na prebavila (driska, napihnjenost, bolečina v trebuhu in navzea), rdečica (pordelost kože) in nizke vrednosti limfocitov (vrste belih krvnih celic) ali belih krvnih celic na splošno.
For more information about treatment with Skilarence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Skilarence preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Skilarence naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys. 
Zdravila Skilarence ne smejo uporabljati bolniki s hudimi težavami s prebavili, jetri ali ledvicami.
The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system. 
Zdravilna učinkovina zdravila Skilarence, dimetilfumarat, zavira delovanje imunskega sistema.
For the full list of all side effects reported with Skilarence, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Skilarence, glejte navodilo za uporabo.
Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis. 
Predpisovanje in izdaja zdravila Skilarence je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem psoriaze.
How does Skilarence work? 
Kako zdravilo Skilarence deluje?
The doctor may reduce the dose when the psoriasis has been brought under control. 
Ko je psoriaza pod nadzorom, zdravnik lahko odmerek zmanjša.
Skilarence contains the active substance dimethyl fumarate. 
Zdravilo Skilarence vsebuje zdravilno učinkovino dimetilfumarat.
How is Skilarence used? 
Kako se zdravilo Skilarence uporablja?
Teva Hungary PLC Pallagi street 13., Debrecen 
Madžarska Teva Hungary PLC Pallagi street 13., Debrecen
Member State in EEA 
Država članica (v EGP)
Bayer Hungaria ltd Alkotás street 50. 
Madžarska Bayer Hungaria ltd Alkotás street 50.
Merck Sharp & Dohme, Lda. 
Portugalska Merck Sharp & Dohme, Lda.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Combined hormonal contraceptives 
Priloga I Seznam poimenovanj, farmacevtskih oblik, jakosti, poti uporabe, imetnikov dovoljenj za promet v državah članicah
Sandoz Hungary LTD Bartók Béla street 4347. 
Madžarska Sandoz Hungary LTD Bartók Béla street 43-47.
Bayer Portugal, S.A. Rua Quinta do Pinheiro 
Portugalska Bayer Portugal, S.A. Rua Quinta do Pinheiro 5
Vaginal use 
Vaginalna uporaba
Laboratórios EFFIK, Sociedade Unipessoal, Lda. 
Portugalska Laboratórios EFFIK, Sociedade Unipessoal, Lda.
Laboratórios Pfizer, Lda. 
Portugalska Laboratórios Pfizer, Lda.
Italfarmaco - Produtos Farmacêuticos, Lda. 
Portugalska Italfarmaco - Produtos Farmacêuticos, Lda.
Vaginal delivery system 
Vaginalni dostavni sistem
Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris France 
Portugalska Medimpex France, S.A 1-3, Rue Caumartin F-75009 Paris
Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78 
Portugalska Actavis Group PTC ehf Reykjavikurvegi 76-78
Germany betapharm Arzneimittel GmbH Kobelweg 95 
Nemčija betapharm Arzneimittel GmbH Kobelweg 95
Sandoz Farmaceutica, Lda. 
Portugalska Sandoz Farmaceutica, Lda.
Czech Republic LadeePharma Kft Lajos utca 48-66. 
Madžarska LadeePharma Kft Lajos utca 48-66
Slovak Republic Ratiopharm GmbH Graf-Arco-Strasse 3 
Madžarska Ratiopharm GmbH Graf-Arco-Strasse 3
Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda. 
Portugalska Lusal, Produção Químico Farmacêutica Luso Alemã, Lda.
Slovak Republic Zentiva, k.s. 
Madžarska Zentiva, k.s.
Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary gestodene ethinylestradiol 
Madžarska Aramis Pharma Kft. Mester u. 28B III/5
540306 Târgu Mureş România 
Str. Cuza-Vodă, nr. 99-105 540306 Târgu Mureş România
Deutschland 
Nemčija
Slovensko 
Slovaška
0.12 mg/0.015 mg Vaginal delivery system 
0.12 mg/0.015 mg Vaginalni dostavni sistem
Teva PharmaProdutos 
Farmacevtska oblika
BerlifarmaEspecialidades Farmacêuticas, Lda. 
Portugalska Berlifarma, Especialidades Farmacêuticas, Lda.
Berlex - Especialidades Farmaceuticas, Lda. 
Portugalska Berlex Especialidades Farmacêuticas Lda.
FAES FARMA, S.A. Maximo Aguirre, 14. 
FAES FARMA, S.A. Maximo Aguirre, 14. 48940 Lamiaco-Lejona (Vizcaya)
SANOFI AVENTIS FRANCE 
Slovenija sanofi-aventis d.o.o.
Czech Republic Medico Uno Pharma Kft. 
Madžarska Medico Uno Pharma Kft. Viadukt u. 12
Slovak Republic mibe GmbH Arzneimittel 
Slovaška mibe GmbH Arzneimittel Münchener Str. 15
Slovak Republic Bayer Pharma AG Müllerstraße 178 
Madžarska Bayer Pharma AG Müllerstrasse 170-178.
Czech Republic mibe GmbH Arzneimittel 
Češka mibe GmbH Arzneimittel Münchener Str. 15
89150 Laichingen Germany 
85737 Ismaning Germany
Germany mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany 
Nemčija mibe GmbH Arzneimittel Münchener Str. 15
Gedeon Richter Plc. 
Madžarska Gedeon Richter Plc.
Czech Republic Laboratorios Leon Farma SA 
Madžarska Laboratorios Leon Farma SA Calle La Vallina S/N
Belgium Gedeon Richter Plc. 
Nizozemska Gedeon Richter Plc.
This was also supported by the SAG AI. 
To je podprla tudi skupina SAG AI.
No new safety risk was identified and the safety profile remains overall unchanged for these products. 
Prepoznali niso nobenega novega tveganja za varnost, varnostni profil teh zdravil pa na splošno ostaja nespremenjen.
It remains unknown whether these differences translate into different clinical effects of the medicinal products; this conclusion was also supported by the scientific advisory group expert group meeting on antiinfectives (SAG AI). 
Še vedno ni znano, ali te razlike pomenijo tudi drugačne klinične učinke zdravil; ta zaključek so podprli tudi na srečanju znanstvene posvetovalne skupine strokovnjakov za antiinfektive (SAG AI).
The Italian National Competent Authority (AIFA) considered that results of recent studies cast doubt on the efficacy of these products in respiratory infections. 
Italijanski pristojni nacionalni organ (AIFA) je presodil, da rezultati nedavnih študij vzbujajo dvom o učinkovitosti teh zdravil pri okužbah dihal.
It is noted that serious hypersensitivity reactions may occur. 
Opozoriti je treba, da lahko pride do resnih preobčutljivostnih reakcij.
No robust study was conducted for Polyvaccinum and no data in adults was identified. 
Z zdravilom Polyvaccinum ni bila opravljena nobena zanesljiva študija in podatkov za odrasle niso našli.
Further in view of the size of the Buccalin tablet, it should not be used in children below 2 years of age; the indication should be revised accordingly. 
Nadalje se zdravilo Buccalin zaradi velikosti tablet ne sme uporabljati pri otrocih, mlajših od 2 let; indikacijo je treba ustrezno popraviti.
The composition, the manufacturing, the formulation, the administered dose, the treatment schedule and the route of administration of different bacterial lysates available in human therapy are heterogeneous. 
Sestava, izdelava, formulacija, dani odmerek, razpored zdravljenja in pot uporabe različnih bakterijskih lizatov, ki so na voljo za zdravljenje ljudi, so raznoliki.
On 8 June 2018 the Italian National Competent Authority (AIFA) therefore triggered a referral under Article 31 of Directive 2001/83/EC and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of bacterial lysates-containing medicinal products for respiratory conditions and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Zato je italijanski pristojni nacionalni organ (AIFA) 8. junija 2018 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosil, naj oceni vpliv zgoraj navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo bakterijske lizate, za bolezni dihal ter izda mnenje o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
The products have different names in the MS and whilst the most common name is used herein it should be understood as applying to all associated names. 
Zdravila imajo v državah članicah različna imena; tu se sicer uporablja najpogostejše ime, vendar se nanaša na vsa povezana imena.
The scope of this procedure is limited to respiratory tract conditions. 
Obseg tega postopka je omejen na bolezni dihal.
• The Committee for Medicinal Products for Human Use (CHMP) considered the procedure under Article 31 of Directive 2001/83/EC for bacterial lysates based medicinal products for use in respiratory conditions. 
• Odbor za zdravila za uporabo v humani medicini (CHMP) je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila na osnovi bakterijskih lizatov za uporabo pri boleznih dihal;
This included the responses submitted by the marketing authorisation holders in writing and during Oral Explanations, the information submitted by a third party, as well as the views expressed by the scientific advisory group on anti-infectives. 
To je vključevalo tudi odgovore, ki so jih pisno in med ustno obrazložitvijo predložili imetniki dovoljenj za promet z zdravilom, informacije, ki so jih predložile tretje osebe, ter mnenja znanstvene posvetovalne skupine strokovnjakov za antiinfektive;
Depending on MS, the paediatric indication covers children from 1 year, 6 months, or without restrictions. 
Odvisno od države članice pediatrična indikacija zajema otroke, stare 1 leto in več, 6 mesecev ali brez omejitve.
Having reviewed the appropriateness of the formulations and pharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection. 
Po pregledu ustreznosti formulacij in farmacevtskih oblik za uporabo pri odobrenih pediatričnih populacijah do starosti 5 let je odbor CHMP menil, da je treba za zdravila Respivax, Buccalin in Ismigen ter suspenzijo za injiciranje Polyvaccinum opraviti študije sprejemljivosti pri otrocih, mlajših od 5 let.
Some indications currently specify that the products should be used for bacterial infections only; however, there are no grounds for this claim as in the available studies no diagnosis of the pathogen was performed. 
Pri nekaterih indikacijah je trenutno navedeno, da je treba zdravila uporabljati samo pri bakterijskih okužbah, vendar ta trditev ni utemeljena, saj v razpoložljivih študijah niso izvajali diagnostike povzročiteljev.
It is noted that the authors of a review article on immunomodulators for the prevention of RTI in children (Cardinale, 2015) concluded that no sufficient evidence for the efficacy of Luivac in the paediatric field was available. 
Treba je opozoriti, da so avtorji preglednega članka o imunomodulatorjih za preprečevanje okužb dihal pri otrocih (Cardinale, 2015) zaključili, da na pediatričnem področju ni na voljo dovolj dokazov o učinkovitosti zdravila Luivac.
The safety information from both clinical trials and pharmacovigilance data was in line with the known safety profile, as described in the product information; rare hypersensitivity/allergic reactions have been reported. 
Informacije o varnosti iz obeh kliničnih preskušanj in farmakovigilančnih podatkov so bile v skladu z znanim varnostnim profilom, kot je opisan v informacijah o zdravilu; poročali so o redkih preobčutljivostnih/alergijskih reakcijah.
Therefore, the CHMP considered that the treatment indication is not appropriate and should be removed. 
Zato je menil, da indikacija za zdravljenje ni primerna in jo je treba izbrisati;
Of note, the Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases does not recommend oral bacterial lysates for the management of adult LRTI (Woodhead, 2011). 
Opozoriti je treba, da delovna skupina Evropskega združenja za dihala (European Respiratory Society) in Evropskega združenja za klinično mikrobiologijo in prenosljive bolezni (European Society for Clinical Microbiology and Infectious Diseases) ne priporoča peroralnih bakterijskih lizatov za obravnavo okužb spodnjih dihal pri odraslih (Woodhead, 2011).
It was also agreed that the treatment indication was not intended to indicate a curative effects but rather to that the products could be used to prevent complications of RTIs or further infections. 
Dogovorjeno je bilo tudi, da indikacija za zdravljenje ne pomeni kurativnih učinkov, pač pa, da se zdravila lahko uporabljajo za preprečevanje zapletov okužb dihal ali nadaljnjih okužb.
Therefore, and taking into account the known very rare risk of serious immunological reactions associated to these products, AIFA considered it to be in the interest of the Union to review the impact of these concerns on the benefit-risk balance of the class of bacterial lysates-based products in their authorised indications for respiratory infections. 
Zato in ob upoštevanju znanega, zelo redkega tveganja za resne imunološke reakcije, povezane s temi zdravili, je organ AIFA ocenil, da je pregled vpliva teh pomislekov na razmerje med tveganji in koristmi razreda zdravil na osnovi bakterijskih lizatov pri njihovih odobrenih indikacijah za okužbe dihal v interesu Unije.
Bacterial lysates-based medicinal products contain several strains of inactivated whole bacteria/bacterial lysates/bacterial fractions claimed to stimulate the immune system to recognise and fight infections. 
Zdravila na osnovi bakterijskih lizatov vsebujejo več sevov inaktiviranih celih bakterij/bakterijskih lizatov/bakterijskih frakcij, ki naj bi stimulirali imunski sistem k prepoznavanju okužb in boju proti njim.
Bacterial lysates-based medicinal products are authorised in various indications including the prevention and/or treatment of different types of respiratory infections. 
Zdravila na osnovi bakterijskih lizatov so odobrena za različne indikacije, vključno s preprečevanjem in/ali zdravljenjem različnih vrst okužb dihal.
The MAHs are encouraged to seek scientific advice to the relevant competent authorities to design these studies. 
Imetnike dovoljenj za promet z zdravilom se spodbuja, naj pri snovanju teh študij uporabijo znanstveno svetovanje pri pristojnih organih.
Overall the data available are of poor quality and do not provide robust evidence of the efficacy of these products in their authorised indications. 
V celoti so razpoložljivi podatki slabe kakovosti in ne zagotavljajo zanesljivih dokazov o učinkovitosti teh zdravil pri njihovih odobrenih indikacijah.
• The CHMP considered that the safety data reviewed was in accordance with the known profile of the products. 
• odbor CHMP je menil, da so pregledani podatki o varnosti v skladu z znanim profilom zdravil;
The analysis of the scientific data concerning bacterial lysates used for the prophylaxis and treatment of RTI was not able to elucidate the mechanism of action of these products. 
Z analizo znanstvenih podatkov o bakterijskih lizatih, ki se uporabljajo za profilakso in zdravljenje okužb dihal, ni bilo mogoče pojasniti mehanizma delovanja teh zdravil.
In one MS the indication in children is limited to bacterial RURTI, while in five others it is also generally authorised as immunotherapy. 
V eni državi članici je indikacija pri otrocih omejena na ponavljajoče se bakterijske okužbe zgornjih dihal, v petih drugih pa je zdravilo na splošno odobreno kot imunoterapija.
Finally the CHMP noted that Polyvaccinum-containing products contain phenol, an excipient that should be avoided. 
Končno je odbor CHMP opozoril, da izdelki, ki vsebujejo zdravilo Polyvaccinum, vsebujejo fenol, pomožno snov, ki se ji je treba izogibati.
The MAH will register reformulated products without phenol by Q1 2022. 
Imetnik dovoljenja za promet z zdravilom bo reformulirana zdravila brez fenola registriral do prvega četrtletja leta 2022.
Respiratory tract infections may be differentiated in upper and lower respiratory tract infections. 
Okužbe dihal lahko ločimo na okužbe zgornjih in spodnjih dihal.
The CHMP noted that underreporting is probable. 
Odbor CHMP je opozoril, da obstaja verjetnost pomanjkljivega poročanja.