FrancophonIA/ELRC3.0 huggingface dataset:
English: Some VMPs that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their activity and use.”
Slovenian: Pri nekaterih zdravilih za uporabo v veterinarski medicini, pri katerih bi se lahko postopek končal po I. fazi, je treba pridobiti dodatne okoljske podatke, da se lahko obravnavajo posebni pomisleki, povezani z njihovim delovanjem in uporabo.“
English: Within this referral the submission of further ecotoxicity and environmental fate data are expected.
Slovenian: V sklopu tega napotitvenega postopka se pričakuje predložitev dodatnih podatkov o ekotoksičnosti in vplivu na okolje.
English: Lastly, an expert report was provided which discusses the need for altrenogest-containing products in pig farming.
Slovenian: Predloženo je bilo tudi strokovno poročilo, ki opisuje potrebo po zdravilih, ki vsebujejo altrenogest, v prašičereji.
English: These scenarios led to a PECsurfacewater ranging from 0.641 ng/l (for a closed system with 80% metabolism) up to 8.98 ng/l (for an open system with 0% metabolism).
Slovenian: Na podlagi teh scenarijev so dobili vrednost PECpovršinska voda od 0,641 ng/l (za zaprt sistem z 80-odstotno presnovo) do 8,98 ng/l (za odprt sistem z 0-odstotno presnovo).
English: 1 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf order to assess the potential risk of Suifertil 4 mg/ml Oral Solution for Pigs to the environment.
Slovenian: 1 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
English: The applicant used Quantitative structure-activity relationship models (QSAR models) to calculate excretion levels of altrenogest and compared them with the measured total gestagen excretion by pigs reported in public literature.
Slovenian: Predlagatelj je za izračun ravni izločanja altrenogesta uporabil modele kvantitativnega razmerja med strukturo in delovanjem (modele QSAR) ter jih primerjal z izmerjenimi skupnimi ravnmi izločanja gestagenov pri prašičih, o katerih so poročali v javni literaturi.
English: Surface water for altrenogest was modelled using FOCUS simulation models, using the two scenarios (open and closed models) with 0% and 80% metabolism each.
Slovenian: Vrednosti altrenogesta v površinskih vodah so bile oblikovane z uporabo simulacijskih modelov FOCUS, ki so vključevali dva scenarija (odprte in zaprte modele) z 0- oziroma 80-odstotno presnovo.
English: Germany expressed concerns regarding a potential serious risk for the environment as the active ingredient is a steroid hormone and data from publicly available literature show a high risk to aquatic organisms arising from other steroids with a similar molecular structure at environmental concentrations far below the trigger value in nanogram range.
Slovenian: Nemčija je izrazila pomisleke glede morebitnega resnega tveganja za okolje, saj je zdravilna učinkovina steroidni hormon, podatki iz javno dostopne literature pa kažejo na veliko tveganje za morske organizme, ki izhaja iz drugih steroidov s podobno molekulsko strukturo pri okoljskih koncentracijah, ki so veliko manjše od vrednosti za sprožitev ocene v razponu v nanogramih.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Suifertil 4 mg/ml Oral Solution for Pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Slovenian: Napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES je bil sprožen zaradi pomislekov, da predlagatelj ni zadostno dokazal okoljske varnosti pri zdravilu Suifertil 4 mg/ml peroralna raztopina za prašiče, saj manjkajo ključni podatki, brez katerih ni mogoče sklepati na okoljsko varnost pri uporabi tega zdravila.
English: The calculated values for altrenogest were 13.5 (in the case of 80% metabolism) and 2.7 (in the case of 0% metabolism) times lower than the total gestagen excretion by pigs.
Slovenian: Izračunane vrednosti za altrenogest so bile 13,5-krat (pri 80-odstotni presnovi) in 2,7-krat (pri 0-odstotni presnovi) manjše kot skupne ravni izločanja gestagenov pri prašičih.
English: Within the ongoing Article 35 referral for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, further ecotoxicity and environmental fate data are expected to be submitted.
Slovenian: V sklopu potekajočega napotitvenega postopka v skladu s členom 35 za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest in se bodo peroralno dajala prašičem ter konjem, se pričakuje, da bodo predloženi dodatni podatki o ekotoksičnosti in vplivu na okolje.
English: A Phase I environmental risk assessment in compliance with the relevant guidelines was provided, which showed that the PECsoil value for pigs does not exceed the VICH threshold of 100 μg/kg.
Slovenian: Skladno z zadevnimi smernicami je bila predložena ocena okoljskega tveganja I. faze, ki je pokazala, da vrednost PECtla pri prašičih ne presega mejne vrednosti VICH 100 μg/kg.
English: Furthermore, Germany considered that appropriate risk mitigation measures (RMM) are missing in the SPC as a consequence of the identified unacceptable risk to aquatic organisms.
Slovenian: Poleg tega Nemčija meni, da v povzetku glavnih značilnosti zdravila manjkajo ustrezni ukrepi za zmanjševanje tveganja, kar je posledica ugotovljenega nesprejemljivega tveganja za vodne organizme.
English: In this procedure, the Committee was asked to consider whether in the case of Suifertil 4 mg/ml Oral Solution for Pigs, containing as the active substance a synthetic hormone (altrenogest), the ‘however clause' should be applied and a tailored Phase II environmental risk assessment should be provided in
Slovenian: Pri tem postopku so odbor prosili, naj presodi, ali je treba pri zdravilu Suifertil 4 mg/ml peroralna raztopina za prašiče, ki kot zdravilno učinkovino vsebuje sintetični hormon (altrenogest), uporabiti „klavzulo vendar“ in predložiti prilagojeno oceno okoljskega tveganja II.
English: Altrenogest is a synthetic steroidal hormone, an orally active (pro)gestagen.
Slovenian: Altrenogest je sintetični steroidni hormon, peroralno aktivni (pro)gestagen.
English: It is included in veterinary medicinal products currently authorised in the European Union for gilts and mares for zootechnical purposes (oestrus synchronisation).
Slovenian: Spada med zdravila za uporabo v veterinarski medicini, ki so v Evropski uniji trenutno odobrena pri mladicah in kobilah za zootehnične namene (sinhronizacijo estrusa).
English: Altrenogest is a synthetic steroidal hormone, an orally active progestogen.
Slovenian: Altrenogest je sintetični steroidni hormon, peroralno aktivni progestagen.
English: A class referral under Article 35 of Directive 2001/82/EC has been initiated in April 2013 for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, the scope of which also includes Suifertil.
Slovenian: V skladu s členom 35 Direktive 2001/82/ES je bil aprila 2013 uveden napotitveni postopek za razred vseh zdravil za uporabo v veterinarski medicini, ki vsebujejo altrenogest in so namenjena peroralni uporabi pri prašičih in konjih.
English: Using the total residue approach for intensively reared animals the PECsoil for pigs was determined to be 3.01 μg/kg and refining by means of FOCUS models led to values of 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems.
Slovenian: Z uporabo pristopa s skupnimi ostanki pri živalih v intenzivni reji so ugotovili, da je vrednost PECtla pri prašičih 3,01 μg/kg, prečiščevanje z modeli FOCUS pa je pokazalo vrednosti 0,93µg/kg za odprte sisteme in 0,36 µg/kg za zaprte sisteme.
English: Based on the currently available data, and in anticipation of a more in-depth assessment of the environmental risk assessment under an ongoing Article 35 referral, the benefit-risk ratio is considered positive for Suifertil 4 mg/ml Oral Solution for Pigs at present.
Slovenian: Na podlagi trenutno razpoložljivih podatkov in v pričakovanju dodatnega podrobnega vrednotenja ocene okoljskega tveganja v skladu z napotitvenim postopkom iz člena 35 je razmerje med tveganji in koristmi zdravila Suifertil 4 mg/ml peroralna raztopina za prašiče trenutno pozitivno.
English: The applicant argued that the environmental load of altrenogest is comparable to other hormones measured and provided public available literature regarding effect concentrations of different hormones in the low ng/l range, but none with altrenogest.
Slovenian: Predlagatelj je dokazoval, da je okoljsko breme altrenogesta primerljivo z drugimi hormoni, kar je izmerjeno in objavljeno v javno dostopni literaturi o koncentracijah različnih hormonov z učinkom znotraj spodnjega razpona v ng/l, vendar nobena publikacija ne vključuje altrenogesta.
English: In order to address the concerns raised by the referral, the applicant provided a Phase I ERA, references from public literature and a scientific justification why the ERA can stop at Phase I and the ‘however clause' should not be invoked.
Slovenian: Za obravnavo pomislekov v napotitvenem postopku je predlagatelj predložil oceno tveganja za okolje I. faze, reference iz javne literature in znanstveno utemeljitev, zakaj se lahko ocena tveganja za okolje konča pri I. fazi in se ni treba sklicevati na „klavzulo vendar“.
English: The referenced ‘however clause' is a provision in the introduction section of VICH GL6 which states “Phase I also identifies VMPs that require a more extensive EIA under Phase II.
Slovenian: Zadevna „klavzula vendar“ je določba v uvodnem delu smernice VICH GL6, ki navaja:„V I. fazi so določena tudi zdravila za uporabo v veterinarski medicini, ki zahtevajo obširnejšo oceno EIA v sklopu II.
English: The applicant provided a Phase I ERA, in which PECsoil initial for the active ingredient was calculated to be 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems, which is considered plausible and acceptable.
Slovenian: Predlagatelj je predložil oceno tveganja za okolje I. faze, pri kateri je bila izračunana koncentracija PECtla prvotna za zdravilno učinkovino 0,93 µg/kg pri odprtih sistemih in 0,36 µg/kg pri zaprtih sistemih, kar je videti verjetno in sprejemljivo.
English: The application in question, submitted via the decentralised procedure, is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Slovenian: Zadevna vloga, predložena v decentraliziranem postopku, je skladno s členom 13(1) Direktive 2001/82/ES, kot je bila spremenjena, generična vloga, ki se nanaša na referenčno zdravilo Regumate oljna raztopina 4 mg/ml.
English: The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in gilts and mares for synchronisation of oestrus.
Slovenian: Zdravilna učinkovina spada med zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah Evropske unije za uporabo pri mladicah in kobilah za sinhronizacijo estrusa.
English: The two studies with the most sensitive results display effects in amphibians and fish already at the lowest test concentration of 1.3 and 0.8 ng/l, respectively.
Slovenian: Rezultati dveh študij z najobčutljivejšimi rezultati so pokazali učinke na dvoživke in ribe že pri najmanjši preiskovani koncentraciji 1,3 oziroma 0,8 ng/l, zato iz teh študij ni mogoče izpeljati koncentracije NOEC (brez opaznega učinka).
English: This is a generic application according to Art. 13(1) of Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Slovenian: Skladno s členom 13(1) Direktive 2001/82/ES, kot je bila spremenjena, je to generična vloga, ki se nanaša na referenčno zdravilo Regumate oljna raztopina 4 mg/ml.
English: Application of the ‘however clause' or can the ERA stop at Phase I
Slovenian: Uporaba „klavzule vendar“ oziroma ali se lahko ocena tveganja za okolje konča pri I. fazi
English: The Phase I environmental risk assessment (ERA) conducted by the applicant for Suifertil indicated a predicted environmental concentration (PEC) in soil below the value of 100 µg active substance per kg soil which triggers a Phase II ERA, therefore no further assessment was carried out.
Slovenian: Ocena tveganja za okolje (ERA) I. faze, ki jo je opravil predlagatelj za zdravilo Suifertil, je pokazala predvideno okoljsko koncentracijo (PEC) v tleh pod vrednostjo 100 µg zdravilne učinkovine na kg tal, kar sproži oceno tveganja za okolje II.
English: The concerns expressed by the objecting CMS in respect to the risk to aquatic organisms do not relate specifically to the product Suifertil 4 mg/ml Oral Solution for Pigs, but equally to all relevant veterinary medicinal products containing the active substance altrenogest.
Slovenian: Pomisleki, ki jih je zadevna država članica izpostavila glede tveganja za vodne organizme, se ne nanašajo izrecno na zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče, ampak na vsa zadevna zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino altrenogest.
English: Studies in the published literature on effects of several hormones other than altrenogest on aquatic organisms indicate adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Slovenian: Študije v objavljeni literaturi o učinkih številnih hormonov, ki niso altrenogest, na vodne organizme kažejo na neželene učinke pri koncentracijah, ki so veliko manjše od vrednosti 100 µg/kg tal, ki zahteva sprožitev dodatne ocene.
English: As there is no product specific concern identified for Suifertil 4 mg/ml Oral Solution for Pigs that is different from the other, already authorised altrenogest containing veterinary medicinal products, it is considered appropriate to await the outcome of the ongoing Article 35 referral before any different conclusions regarding the environmental risk assessment or specific measures would be envisaged for Suifertil 4 mg/ml Oral Solution for Pigs.
Slovenian: Ker z zdravilom Suifertil 4 mg/ml peroralna raztopina za prašiče, ki se razlikuje od drugih, že odobrenih zdravil za uporabo v veterinarski medicini, ki vsebujejo altrenogest, ni povezan noben pomislek, ki bi bil specifičen za to zdravilo, je primerno, da počakamo na izid potekajočega napotitvenega postopka iz člena 35, preden se za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče predvidijo kakršni koli drugačni zaključki glede ocene okoljskega tveganja ali posebnih ukrepov.
English: The submitted published literature on effect studies for three other hormones, the gestagens levonorgestrel, drosperinone and progestrerone, is indicating adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Slovenian: Predložena objavljena literatura o študijah učinkov treh drugih hormonov gestagenov, levonorgestrela, drosperidona in progestrerona, kaže na neželene učinke pri koncentracijah, veliko manjših od vrednosti 100 µg/kg tal, ki zahteva sprožitev dodatne ocene.
English: It is considered appropriate to await the outcome of the ongoing Article 35 referral before any specific measures would be envisaged for Suifertil 4 mg/ml Oral Solution for Pigs.
Slovenian: Meni, da je primerno počakati na izid potekajočega napotitvenega postopka iz člena 35, preden se za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče predvidijo kakršni koli posebni ukrepi.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs and associated names
Slovenian: Znanstveni zaključki in podlaga za odobritev dovoljenja za promet z zdravilom Suifertil 4 mg/ml peroralna raztopina za prašiče in povezanimi imeni
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Slovenian: V tem napotitvenem postopku je bilo sklenjeno, da niso potrebni nobeni dodatni ukrepi za obvladovanje ali zmanjševanje tveganja.
English: Consequently, the applicant concluded that the ERA can stop at Phase I. Additionally, the applicant provided a scientific justification why the ‘however clause' of VICH GL6 should not be invoked.
Slovenian: Poleg tega je predlagatelj predložil znanstveno utemeljitev, zakaj ni treba uveljaviti „klavzule vendar“ v smernici VICH GL6.
English: The applicant submitted an application for a decentralised procedure for Suifertil 4 mg/ml Oral Solution for Pigs.
Slovenian: Predlagatelj je predložil vlogo za decentralizirani postopek za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče.
English: The proposed indication for Suifertil 4 mg/ml Oral Solution for Pigs is to synchronise oestrus in sexually mature gilts.
Slovenian: Predlagana indikacija za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče je sinhronizacija estrusa pri spolno zrelih mladicah.
English: The Netherlands
Slovenian: Država članica
English: Germany considered that the data provided are inadequate to conclude that altrenogest will not pose a risk to the environment and that a tailored Phase II ERA based on the so called ‘however clause' of VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I1 is necessary.
Slovenian: Nemčija je menila, da so predloženi podatki nezadostni, da bi lahko zaključili, da altrenogest ne bo predstavljal tveganja za okolje in da prilagojena ocena tveganja za okolje II.
English: Suifertil 4 mg/ml Oral Solution for Pigs is intended for synchronisation of oestrus in sexually mature pigs.
Slovenian: Zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče je namenjeno sinhronizaciji estrusa pri spolno zrelih prašičih.
English: Overall summary of the scientific evaluation of Suifertil 4 mg/ml Oral Solution for Pigs
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Suifertil 4 mg/ml peroralna raztopina za prašiče
English: Grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs
Slovenian: Podlaga za odobritev dovoljenja za promet z zdravilom Suifertil 4 mg/ml peroralna raztopina za prašiče
English: EU Number
Slovenian: EU (MA) številka Izmišljeno ime
English: Median time to event (days)
Slovenian: Mediana časa do dogodka (dnevi)
English: • Take the tablets in the morning and evening as prescribed by your doctor.
Slovenian: • Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
English: This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Slovenian: To je pomembno, ker lahko jemanje več zdravil hkrati poveča ali oslabi njihov učinek.
English: • It is important that you take all your medicine as prescribed by your doctor.
Slovenian: • Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
English: Ethnic factors
Slovenian: Etnični dejavniki
English: DPD deficiency
Slovenian: Pomanjkanje DPD
English: • Fever: if you have a temperature of 38 °C or greater.
Slovenian: • Zvišana telesna temperatura: če imate telesno temperaturo 38 °C ali več.
English: • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
Slovenian: • Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje); tablete pogoltnite cele z vodo.
English: • if you have a history of eye problems as you may need extra monitoring of your eyes,
Slovenian: • če ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči,
English: Also, you need to be particularly careful if you are taking any of the following:
Slovenian: Posebno previdni morate biti tudi pri uporabi:
English: • loss of appetite (anorexia)
Slovenian: • izguba apetita (anoreksija).
English: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Slovenian: Pomanjkanje DPD je redko prirojeno stanje, ki navadno ne povzroča težav z zdravjem, razen če prejmete določena zdravila.
English: • unusual bleeding from the vagina
Slovenian: • neobičajna krvavitev iz vagine,
English: • blurred or double vision
Slovenian: • zamegljen ali dvojni vid,
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
Slovenian: C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
English: • specific changes in the electrocardiogram (QT prolongation)
Slovenian: • specifične spremembe elektrokardiograma (podaljšanje intervala QT),
English: Date of latest renewal: 16 June 2017
Slovenian: Datum prve pridobitve dovoljenja za promet: 19. november 2012 Datum zadnjega podaljšanja: 16. junij 2017
English: Rare/Very rare (Post-marketing experience)
Slovenian: Redki/zelo redki (izkušnje po prihodu zdravila na trg)
English: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na kapecitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Interrupt until resolved to grade 0-1
Slovenian: 1. pojav prekinitev, dokler ni dosežena stopnja 0-1
English: The AUC of 5-FU was 30 % - 35 % higher on day 14.
Slovenian: AUC 5-FU je bila od 30 do 35 % višja štirinajstega dne.
English: Capecitabine medac tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Slovenian: Tablete zdravila Kapecitabin medac se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
English: • if you have brain diseases (for example cancer that has spread to the brain) or nerve damage
Slovenian: • če imate možgansko bolezen (na primer raka, ki se širi v možgane) ali poškodbo živcev
English: • if you have a severe skin reaction.
Slovenian: • imate hudo kožno reakcijo.
English: • difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Slovenian: • težave z govorjenjem, moten spomin, izguba koordinacije gibanja, motnja ravnotežja,
English: Finally, β-ureido-propionase cleaves FUPA to FBAL which is cleared in the urine.
Slovenian: Na koncu β-ureido-propionaza cepi FUPA v FBAL, ki se izloči z urinom.
English: ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Slovenian: ** Na podlagi izkušenj po prihodu zdravila na trg lahko vztrajen ali hud sindrom palmarno-plantarne eritrodisestezije sčasoma privede do izgube prstnih odtisov (glejte poglavje 4.4).
English: The AUC of FBAL increased with age (20 % increase in age results in a 15 % increase in the AUC of FBAL).
Slovenian: AUC za FBAL je z leti naraščala (20 % povečanje v letih daje 15 % povečanje AUC za FBAL).
English: Parameter: Overall survival
Slovenian: Parameter: Celokupno preživetje
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects).
Slovenian: Nemudoma obvestite zdravnika, če vas skrbi kateri koli od neželenih učinkov ali če opazite kateri koli dodatni neželeni učinek, ki ni naveden v tem navodilu (glejte poglavje 4 Možni neželeni učinki).
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Slovenian: (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: • inflammation of the skin causing red scaly patches due to an immune system illness
Slovenian: • vnetje kože, ki povzroči rdeče srbeče zaplate zaradi bolezni imunskega sistema.
English: • difficulty in urination, blood or protein in the urine
Slovenian: • težave pri uriniranju, kri ali beljakovine v urinu,
English: • ringing or buzzing in the ears (tinnitus), loss of hearing
Slovenian: • zvonjenje ali brnenje v ušesih (tinitus), izguba sluha,