natgillin/translations-raw huggingface dataset:
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Trimetazidin je pri odraslih bolnikih indiciran kot dodatno zdravilo za simptomatsko zdravljenje bolnikov s stabilno angino pektoris, pri katerih z zdravili prve izbire te bolezni ni mogoče zadovoljivo nadzorovati oziroma bolniki zdravljenja z njimi ne prenašajo.
Arterial Hypotension , Orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing
Žilne bolezni redki arterijska hipotenzija, ortostatska hipotenzija, ki je lahko povezana s splošnim slabim počutjem, omotico ali padcem, zlasti pri bolnikih, zdravljenih z antihipertenzivi, zardevanje
If you get any side effects, talk to your doctor or pharmacist.
Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
Patients with renal impairment
Bolniki z ledvično okvaro:
In a 426-patients randomized, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p<0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
V randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 426 bolnikih (TRIMPOL-II) je trimetazidin (60 mg/dan) poleg metoprolola v odmerku 100 mg dnevno (50 mg dvakrat dnevno) v 12 tednih statistično značilno izboljšal parametre obremenitvenih testov in klinične simptome v primerjavi s placebom: trajanje celotne vadbe +20,1 s, p = 0,023, skupna obremenitev +0,54 MET, p = 0,001, čas do nastopa za 1 mm znižane veznice ST +33,4 s, p = 0,003, čas do nastopa angine pektoris +33,9 s, p < 0,001, število anginoznih napadov/teden -0,73, p = 0,014, in poraba kratko delujočih nitratov/teden, -0,63, p = 0,032, brez hemodinamičnih sprememb.
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2).
Pri starejših bolnikih je zaradi s starostjo povezanega zmanjšanega delovanja ledvic izpostavljenost trimetazidinu lahko večja (glejte poglavje 5.2).
What you need to know before you take <invented name> Do not take <invented name> - if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section - if you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture,
Ne jemljite zdravila <Izmišljeno ime> - če ste alergični na trimetazidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate Parkinsonovo bolezen: bolezen možganov, ki vpliva na gibanje (tresenje, okorela drža, počasni gibi in negotova, neuravnotežena hoja), - če imate hude težave z ledvicami.
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
V primeru pojava motenj gibanja, kot so simptomi Parkinsonove bolezni, sindrom nemirnih nog, tremor, nestabilna hoja, je treba zdravljenje s trimetazidinom dokončno ukiniti.
What <invented name>is and what it is used for This medicine is intended for use in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease).
To zdravilo je pri odraslih bolnikih skupaj z drugimi zdravili namenjeno za zdravljenje angine pektoris (bolečine v prsih, ki jo povzroča koronarna bolezen).
Palpitations, extrasystoles, tachycardia
Srčne bolezni redki palpitacije, ekstrasistole, tahikardija
This medicine can cause or worsen symptoms such as trembling, rigid posture, slow movements and a shuffling, unbalanced walk, especially in elderly patients, which should be investigated and reported to your doctor who could reassess the treatment.
To zdravilo lahko povzroči ali poslabša simptome, kot so tresenje, okorela drža, počasni gibi in negotova, neuravnotežena hoja, zlasti pri starejših bolnikih.
In a 1962 patients three-month randomised, double-blinded study (Vasco study) on top of atenolol 50 mg/d, two dosages of trimetazidine (70 mg/d and 140 mg/d) were tested versus placebo.
V randomizirani, dvojno slepi trimesečni študiji pri 1962 bolnikih (študija VASCO) so dve odmerjanji trimetazidina (70 mg/dan in 140 mg/dan) poleg atenolola 50 mg/dan primerjali s placebom.
The recommended dose of <invented name> 35mg is one tablet to be taken two times a day during meals in the morning and evening.
Priporočeni odmerek zdravila <Izmišljeno ime> 35 mg je ena tableta dvakrat na dan med obrokom, zjutraj in zvečer.
However, in the subgroup of symptomatic patients (n= 1574) defined in a post-hoc analysis, trimetazidine (140 mg) significantly improved total exercise duration (+23.8 s versus +13.1 s placebo; p=0.001) and time to onset of angina (+46.3 s versus +32.5 s placebo; p=0.005).
Kljub temu je trimetazidin (140 mg) pri podskupini simptomatskih bolnikov (n=1574), določeni v naknadni analizi, značilno izboljšal trajanje celotne vadbe (+23,8 s v primerjavi s +13,1 s pri placebu; p=0,001) in čas do nastopa angine pektoris (+46,3 s v primerjavi s +32,5 s pri placebu; p=0,005).
Driving and using machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
Sleep disorders (insomnia, drowsiness)
Bolezni živčevja neznana pogostnost motnje spanja (nespečnost, zaspanost)
In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels.
Trimetazidin pri bolnikih z ishemično boleznijo srca deluje na presnovo celic srčne mišice in v njih ohranja visoko raven energetsko bogatih fosfatov.
4.3 Contraindications [the currently approved contraindications should be deleted and replaced by the following]
[trenutno odobrene kontraindikacije je treba izbrisati ter jih nadomestiti z naslednjimi]
Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
Trimetazidin lahko povzroči ali poslabša simptome Parkinsonove bolezni (tremor, akinezijo, hipertonijo).
B. Package Leaflet
B. Navodilo za uporabo
Acute generalized exanthematus pustulosis (AGEP), angioedema
Bolezni kože in podkožja neznana pogostnost akutna generalizirana eksantematozna pustuloza (AGEP), angioedem
The dose is one tablet of 20mg or 1 ml (20 drops) of oral drop solution of trimetazidine three times a day during meals.
Odmerek je ena tableta z 20 mg trimetazidina ali 1 ml (20 kapljic) peroralne raztopine trimetazidina trikrat dnevno med obrokom.
The recommended dose of <invented name> 20mg/ml solution is 20 drops to be taken three times a day during meals.
Priporočeni odmerek zdravila <Izmišljeno ime> 20 mg/ml raztopina je 20 kapljic trikrat na dan med obrokom.
No significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Za druge sekundarne opazovane dogodke (trajanje celotne vadbe, skupno obremenitev in klinične opazovane dogodke) med skupinama niso našli značilnih razlik.
Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restlessleg syndrome, other related movement disorders, usually reversible after treatment discontinuation
Prednostni izraz omotica, glavobol neznana pogostnost simptomi Parkinsonove bolezni (tremor, akinezija, hipertonija), nestabilna hoja, sindrom nemirnih nog, druge podobne motnje gibanja, simptomi so običajno reverzibilni po prekinitvi zdravljenja
The recommended dose of <invented name> 20mg is one tablet to be taken three times a day during meals.
Priporočeni odmerek zdravila <Izmišljeno ime> 20 mg je ena tableta trikrat na dan med obrokom.
Talk to your doctor or pharmacist before taking <invented name>
Kaj morate vedeti, preden boste vzeli zdravilo <Izmišljeno ime>
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 - 60 ml/min) (glejte poglavji 4.4 in 5.2) je priporočeni odmerek 1 tableta s 35 mg trimetazidina zjutraj med zajtrkom.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 - 60 ml/min) je priporočeni odmerek 1 tableta s 35 mg trimetazidina zjutraj med zajtrkom.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 - 60 ml/min) (glejte poglavji 4.4 in 5.2) je priporočeni odmerek 1 tableta z 20 mg trimetazidina ali 1 ml (20 kapljic) peroralne raztopine trimetazidina dvakrat dnevno, t.j.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Pri bolnikih z zmerno ledvično okvaro (očistek kreatinina 30 - 60 ml/min) je priporočeni odmerek 1 tableta z 20 mg trimetazidina ali 1 ml (20 kapljic) peroralne raztopine trimetazidina dvakrat dnevno, t.j.
Dizziness, headache, abdominal pain, diarrhoea, indigestion, feeling sick, vomiting, rash, itching, hives and feeling of weakness.
Bolezni prebavil bolečine v trebuhu, diareja, dispepsija, navzea in bruhanje neznana pogostnost zaprtje pogosti izpuščaj, pruritus, urtikarija
- Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, - Severe renal impairment (creatinine clearance < 30ml/min).
- Parkinsonova bolezen, simptomi Parkinsonove bolezni, tremor, sindrom nemirnih nog in druge podobne motnje gibanja.
Agranulocytosis Thrombocytopenia Thrombocytopenic purpura
Bolezni krvi in limfatičnega sistema neznana pogostnost agranulocitoza trombocitopenija trombocitopenična purpura
added to 50 mg atenolol (o.d.) for 8 weeks produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a subgroup of patients (n=173), when compared to placebo, 12 hours after taking the drug.
V randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 223 bolnikih (Sellier) je ena tableta s prirejenim sproščanjem s 35 mg trimetazidina (dvakrat dnevno) poleg 50 mg atenolola (enkrat dnevno) pri podskupini bolnikov (N=173) v 8 tednih povzročila značilno podaljšanje (+34,4 s, p = 0,03) časa do nastopa za 1 mm znižane veznice ST med obremenitvenim testom v primerjavi s placebom, 12 ur po jemanju zdravila.
4.7 Effects on ability to drive and use machines [the currently approved wording of this section should be deleted and replaced by the following]
[trenutno odobreno besedilo v tem poglavju je treba izbrisati ter ga nadomestiti z naslednjim]
The reference Member State is the United Kingdom.
Referenčna država članica je Združeno kraljestvo.
Direct therapeutic benefit
Neposredna terapevtska korist
The concerned Member States involved are Germany and the Netherlands.
Zadevni državi članici v postopku sta Nemčija in Nizozemska.
No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Dodatnih študij, s katerimi bi podrobneje opredelili to tveganje, niso opravili, saj navodila na tem področju trenutno niso na voljo.
4.5 Special precautions for use iii.
4.5 Posebni previdnostni ukrepi iii.
Assessment of the data submitted
Ocena predloženih podatkov
The ERA was full and complete in terms of data requirements.
OTO je bila z vidika zahtevanih podatkov celovita in popolna.
Quality, target animal safety, user safety, residues and resistance were not assessed in this referral procedure, but all risks were addressed during the decentralised procedure.
Kakovosti, varnosti zdravila za ciljno živalsko vrsto, varnosti za uporabnika, ostankov in odpornosti v okviru tega napotitvenega postopka niso ocenjevali, so pa vsa tveganja obravnavali med decentraliziranim postopkom.
Other precautions
Drugi previdnostni ukrepi
The active substance is well known and is included in veterinary medicinal products currently authorised in the EU for use in cattle.
Ta zdravilna učinkovina je dobro znana in je prisotna v zdravilih za uporabo v veterinarski medicini, ki so trenutno odobrena v EU za uporabo pri govedu.
Risk management or mitigation measures
Ukrepi za obvladovanje ali zmanjšanje tveganja
The benefit-risk for the product can be considered to be positive.
Razmerje med tveganji in koristmi zdravila se lahko oceni kot pozitivno.
It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of this product.
Ocena je zagotovila vse podatke, ki so bili potrebni za sprejetje zaključkov o tveganju za okolje, ki ga predstavlja uporaba tega zdravila.
Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms.
Tako kot drugi makrociklični laktoni, lahko ima eprinomektin neželene učinke pri neciljnih organizmih.
5.3 Environmental properties
5.3 Okoljski podatki
The valid Summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine, z naslednjimi spremembami:
The amended summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Spremenjeni povzetek glavnih značilnosti zdravila in navodilo za uporabo referenčne države članice sta opredeljena v Prilogi III.
Eprinomectin residues will be introduced into the environment following direct excretion onto pasture.
Ostanki eprinomektina bodo v okolje vneseni po neposrednem izločanju na pašnik.
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Po proučitvi predloženih podatkov je odbor glede vprašanj, ki jih je v uradnem obvestilu poslala Nemčija, podal zaključke, ki so navedeni v nadaljevanju.
Eprinomectin has a n-octanol/water partition coefficient (KOW, expressed as log KOW) of 6.5 which was tested in a valid KOW study according to guideline 117 of the Organisation for Economic Co-operation and Development (OECD)4.
Eprinomektin ima porazdelitveni koeficient n-oktanol/voda (KOW, izražen kot log KOW), ki znaša 6,5, kar so preverili v veljavni študiji KOW v skladu s smernicami 117 Organizacije za gospodarsko sodelovanje in razvoj (OECD)4.
In conclusion eprinomectin was not considered to be a PBT compound.
Posledično so zaključili, da eprinomektin ni snov PBT.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalske vrste, pot uporabe, vlagatelj v državi članici
Evaluation of secondary poisoning showed the risk quotient values for terrestrial and aquatic predators were <1 and further assessment was not required.
Ocena možnosti sekundarne zastrupitve je pokazala, da so vrednosti količnika tveganja za zemeljske in vodne plenilce manj kot 1, zato nadaljnje ocene niso bile potrebne.
Strength Pharmaceutical form
Jakost FARMACEVTSKA OBLIKA
Add the following text in the relevant sections of the product information:
V zadevna poglavja informacij o zdravilu se doda naslednje besedilo:
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.
Tveganje za vodne ekosisteme in v iztrebkih živeče organizme zmanjšamo z izogibanjem prepogosti in ponavljajoči se uporabi eprinomektina (in antihelmintikov istega razreda) pri govedu.
Potential serious risks were identified during the decentralised procedure by Germany who considered that eprinomectin might potentially be a PBT (persistent, bioaccumulative and toxic) substance.
Med decentraliziranim postopkom je Nemčija ugotovila možnost resnega tveganja, saj je menila, da bi eprinomektin lahko bil snov, ki je obstojna, strupena in se lahko kopiči v organizmih (persistent, bioaccumulative and toxic - PBT).
Results from a bioaccumulation study according to OECD guideline 3055 demonstrate that eprinomectin is not likely to concentrate to levels that would pose a risk to aquatic organisms.
Rezultati študije o kopičenju v organizmih, skladne s smernicami OECD 3055, kažejo, da ni verjetno, da bi koncentracija eprinomektina postala tako velika, da bi predstavljala tveganje za vodne organizme.
An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Predložena je bila ocena tveganja za okolje, skladna s smernicami VICH in odbora CVMP, ki je vsebovala objavljene študije in študije po naročilu predlagatelja ter je obravnavala vse vidike tveganja za okolje.
Germany Norbrook Laboratories Limited
Nemčija Norbrook Laboratories Limited
In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Da bi odpravil zadržke, zaradi katerih je bil sprožen napotitveni postopek, je predlagatelj predložil oceno tveganja za okolje (OTO), skladno s smernicami VICH GL61 in GL382 ter smernicami odbora CVMP v podporo smernicam VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005)3.
A screening for PBT properties as required by the CVMP guidelines indicated that eprinomectin fulfils the criteria for 'P' and 'T' but it was considered not to be 'B'.
Pregled za ugotavljanje lastnosti PBT v skladu z zahtevami smernic odbora CVMP je pokazal, da eprinomektin izpolnjuje kriterije za „P“ in „T“, ne pa tudi za „B“.
The benefit of the products is treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages, mange mites, lice and horn flies by using this product.
Uporaba tega zdravila je koristna za zdravljenje in nadzorovanje okužb z želodčno-črevesnimi glistami (odraslimi in ličinkami v četrti fazi razvoja), pljučnimi črvi (odraslimi in ličinkami v četrti fazi razvoja), govejimi zolji (v parazitskem stadiju), garjami, ušmi in muhami Haematobia irritans.
The application in question, submitted via the decentralised procedure, is a ‘hybrid' application according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex Pour-On Solution for Beef and Dairy Cattle authorised in the United Kingdom.
Obravnavana vloga, predložena po decentraliziranem postopku, je v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, „hibridna vloga“, ki se nanaša na referenčno zdravilo Eprinex kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, ki je odobreno v Združenem kraljestvu.
4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en duration of eprinomectin excretion and the keep off from water bodies two to five weeks after treatment.
4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en tudi za živali, prisotne v gnoju.
The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Tveganje za vodne ekosisteme in v iztrebkih živeče organizme se dodatno zmanjša, če se zdravljenim živalim v obdobju dva do pet tedne po zdravljenju prepreči neposreden dostop do vodotokov.
Based on the fate data of eprinomectin and the outcome of the PBT assessment it was additionally considered to address the persistency in soil.
Na podlagi podatkov o usodi eprinomektina v okolju in izida ocenjevanja lastnosti PBT so naknadno razmislili tudi o vključitvi informacij o obstojnosti v tleh.
Annex II
Dodatek II
Amendments in the relevant sections of the Summary of product characteristics and package leaflet
Spremembe zadevnih poglavij Povzetka glavnih značilnosti zdravila in navodil za uporabo
Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.
Eprinomektin je zelo toksičen za vodne organizme, obstojen v zemlji in se lahko kopiči v usedlinah.
Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
Potem ko je proučil vso predloženo pisno dokumentacijo, je odbor CVMP zaključil, da OTO za Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, kaže, da ni pričakovati, da bi zdravilo predstavljalo tveganje za okolje, če se bo uporabljalo tako, kot je priporočeno v povzetku glavnih značilnosti zdravila, kar vključuje upoštevanje priporočenih ukrepov za zmanjšanje tveganja.
Valid data on the acute and developmental toxicity of eprinomectin to dung beetle larvae were provided which indicated that risk quotient values for dung insects were >1.
Predloženi so bili utemeljeni podatki o akutni in reproduktivni toksičnosti eprinomektina za ličinke hroščev, prisotnih v gnoju, ki kažejo, da so vrednosti količnika tveganja za žuželke, prisotne v gnoju, večje od 1.
The deriving bioaccumulation potential and the potential for being considered a PBT compound and secondary poisoning were addressed as required by VICH and CVMP guidelines.
Možnost, da bi se zato snov lahko kopičila v organizmih in da bi jo lahko uvrstili med snovi PBT, ter možnost sekundarne zastrupitve so proučili v skladu z zahtevami smernic VICH in odbora CVMP.
Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Da bi zmanjšali tveganje za žuželke, prisotne v gnoju, so bili zato v informacije o zdravilu vključeni ukrepi za zmanjšanje tveganja.
Annex III
Dodatek III
Eprinomectin fulfils the 'P' criterion as a conclusion from the PBT assessment and has a high adsorption coefficient (KOC).
Na podlagi ocene lastnosti PBT je bilo zaključeno, da eprinomektin izpolnjuje kriterij „P“ in ima visok absorpcijski koeficient (KOC).
On the basis of the ERA no other RMMs were proposed by the applicant.
Na osnovi OTO predlagatelj ni predlagal nobenih drugih ukrepov za zmanjšanje tveganja.