natgillin/translations-raw huggingface dataset:
The most common side effects (affecting inbetween 1 to 10 animals in 1,000 animals) were vomiting, diarrhoea, lack of energy, decreased appetite, and itching, which generally were short-lived and resolved spontaneously. 
Najpogostejši neželeni učinki (ki prizadenejo od 1 do 10 živali od 1 000) so bili bruhanje, driska, pomanjkanje energije, zmanjšan tek in srbenje, ki pa so bili na splošno kratkotrajni in so izzveneli sami od sebe.
The European Medicines Agency decided that Nexgard Spectra's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Nexgard Spectra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Nexgard Spectra received a marketing authorisation valid throughout the EU on 15 January 2015. 
Za zdravilo Nexgard Spectra je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
In the case of accidental ingestion, particularly in the case of children, medical advice should be sought immediately and the package leaflet or label shown to the doctor. 
V primeru nenamernega zaužitja, predvsem pri otrocih, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected. 
Ker se morajo bolhe in klopi začeti hraniti s krvjo psa, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti zajedavci lahko okuženi.
The appropriate strength of tablets should be used according to the dog's weight. 
Ustrezna jakost tablete se določi glede na telesno maso psa.
The effectiveness of Nexgard Spectra was investigated in both laboratory and field studies. 
Učinkovitost zdravila Nexgard Spectra so proučevali v laboratorijskih in terenskih študijah.
Tablets should be kept in the blister packs until required, and the blisters should be kept in the carton. 
Tablete je treba shranjevati v pretisnih omotih, dokler jih ne potrebujete, pretisne omote pa je treba shranjevati v škatli.
For prevention of lungworm disease, in areas where infection regularly occurs, and for prevention of eye worm, monthly treatment is given. 
Za preprečevanje okužb s pljučno glisto na območjih, kjer se redno pojavlja, in za preprečevanje okužbe z očesnimi črvi, se izvaja mesečno zdravljenje.
After which, further flea and tick treatment should be continued with a monovalent product containing a single active substance. 
Potem je treba zdravljenje nadaljevati z monovalentnim zdravilom, ki vsebuje samo eno učinkovino.
Nexgard Spectra (afoxolaner/milbemycin oxime) 
Nexgard Spectra (afoksolaner/milbemicin oksim)
The active substances in Nexgard Spectra work by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the parasitic organism. 
Učinkovine v zdravilu Nexgard Spectra delujejo tako, da ovirajo pot, po kateri potujejo signali med živčnimi celicami v živčnem sistemu zajedavcev, kar povzroči paralizo in pogin zajedavskih organizmov.
For more information about using Nexgard Spectra, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila Nexgard Spectra glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
A laboratory study involved 20 dogs artificially infected with lungworm larvae. 
V laboratorijsko študijo je bilo vključenih 20 psov, namerno okuženih z ličinkami pljučne gliste.
Other information about Nexgard Spectra 
Druge informacije o zdravilu Nexgard Spectra
Why is Nexgard Spectra authorised in the EU? 
Zakaj je bilo zdravilo Nexgard Spectra odobreno v EU?
Nexgard Spectra reduced the number of fleas and ticks by at least 95% and was at least as effective as pyriprole. 
Zdravilo Nexgard Spectra je zmanjšalo število bolh in klopov za najmanj 95 % in je bilo vsaj tako učinkovito kot piriprol.
Milbemycin oxime acts as an ‘endoparasiticide'. 
Milbemicin oksim deluje kot „endoparaziticid“.
Nexgard Spectra is available as chewable tablets in five different strengths for use in dogs of different weights. 
Zdravilo Nexgard Spectra je na voljo v obliki žvečljivih tablet petih različnih jakosti, namenjenih za uporabo pri psih z različno telesno maso.
For demodectic mange, treatment should be repeated monthly until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) whereas for sarcoptic mange treatment is given monthly for two months, or longer based on clinical signs and skin scrapings. 
Za zdravljenje garjavice vrste Demodex canis je treba zdravljenje ponavljati enkrat na mesec dokler garjavica ni uspešno odpravljena (kar se potrdi z dvema negativnima ostružkoma kože, vzetima z enomesečnim razmikom), medtem ko je treba pri garjavici vrste Sarcoptes scabiei zdravilo dajati v mesečnih presledkih dva meseca ali dlje, odvisno od kliničnih znakov in ostružkov kože.
The study showed that Nexgard Spectra was effective in treating flea and tick infestations in dogs for up to 30 days after treatment. 
Študija je pokazala, da je bilo zdravilo Nexgard Spectra učinkovito pri zdravljenju infestacij z bolhami in klopi pri psih do 30 dni po zdravljenju.
An overview of Nexgard Spectra and why it is authorised in the EU 
Pregled zdravila Nexgard Spectra in zakaj je odobreno v EU
The study showed that Nexgard Spectra was effective in reducing gut worms and was at least as effective as the milbemycin oxime and praziquantel. 
Študija je pokazala, da je bilo zdravilo Nexgard Spectra učinkovito pri zmanjševanju črevesnih zajedavcev in da je bilo vsaj tako učinkovito kot milbemicin oksim in prazikvantel.
Afoxolaner acts as an ‘ectoparasiticide'. 
Afoksolaner deluje kot „ektoparaziticid“.
In a field study conducted at sites in Europe where cases of eye worm are known to exist, dogs were confirmed free of eye worm at the start of the study. 
Na krajih v Evropi, kjer je znana prisotnost očesnega črva, so izvedli terensko študijo, v katero so bili vključeni psi, ki na začetku študije niso bili okuženi.
Ten dogs were given Nexgard Spectra and the other 10 were untreated. 
Deset psov je nato prejelo zdravilo Nexgard Spectra, deset pa jih niso zdravili.
Flea and tick infestations 
Infestacije z bolhami in klopi
What is Nexgard Spectra and what is it used for? 
Kaj je zdravilo Nexgard Spectra in za kaj se uporablja?
Nexgard Spectra is a veterinary medicine used to treat infestations with fleas, ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs when prevention of heartworm disease (caused by a worm that infects the heart and blood vessels and is transmitted by mosquitoes), lungworm disease, eye worm and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required. 
Nexgard Spectra je zdravilo za uporabo v veterinarski medicini za zdravljenje infestacij z bolhami in klopi ter garjavice vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) pri psih, kadar je treba tudi preprečiti okužbe s srčno glisto (ki jo povzroči glista, ki okuži srce in krvne žile in se prenaša s komarji), okužbe s pljučno glisto, okužbe z očesnimi črvi in/ali zdraviti črevesne zajedavce (trakulje, gliste, bičeglavce).
Nexgard Spectra reduced the number of live mites by 96% 56 days after starting treatment and by 98% 84 days after starting treatment. 
Zdravilo Nexgard Spectra je v 56 dneh po začetku zdravljenja zmanjšalo število živih garjavcev za 96 %, 84 dni po začetku zdravljenja pa za 98 %.
What are the risks associated with Nexgard Spectra? 
Kakšna tveganja so povezana z zdravilom Nexgard Spectra?
Thirty seven dogs were treated with Nexgard Spectra and 42 dogs were treated with afoxolaner alone, which has no action against eye worm. 
Z zdravilom Nexgard Spectra so zdravili 37 psov, 42 psov pa je prejemalo samo afoksolaner, ki proti očesnim črvom ni učinkovit.
Nexgard Spectra reduced the number of live mites by 99% 28 days after starting treatment and by 100% 56 days after starting treatment. 
Zdravilo Nexgard Spectra je v 28 dneh po začetku zdravljenja zmanjšalo število živih garjavcev za 99%, 56 dni po začetku zdravljenja pa za 100%.
What benefits of Nexgard Spectra have been shown in studies? 
Kakšne koristi je zdravilo Nexgard Spectra izkazalo v študijah?
Field studies involving 84 dogs in Japan and 320 dogs in the USA, none of which had heartworm before the treatment started, showed that Nexgard Spectra given monthly for six months prevented heartworm infection. 
Terenske študije s 84 predhodno neokuženimi psi na Japonskem in 320 predhodno neokuženimi psi v ZDA so pokazale, da so bile okužbe s srčno glisto preprečene, če se je zdravilo Nexgard Spectra dajalo šest mesecev zapored enkrat mesečno.
For prevention of heartworm disease, treatment is given monthly during the mosquito season. 
Za preprečevanje okužb s srčno glisto se zdravljenje izvaja vsak mesec v obdobju, ko so dejavni komarji.
Nexgard Spectra contains the active substances afoxolaner and milbemycin oxime. 
Zdravilo Nexgard Spectra vsebuje učinkovini afoksolaner in milbemicin oksim.
In a field study, 408 dogs with gut worm infections were given either a single treatment with Nexgard Spectra or a medicine containing milbemycin oxime and praziquantel (another medicine for worms). 
V terensko študijo glede črevesnih zajedavcev je bilo vključenih 408 psov, okuženih s črevesnimi zajedavci, ki so prejeli bodisi enojni odmerek zdravila Nexgard Spectra bodisi zdravilo, ki vsebuje milbemicin oksim in prazikvantel (drugo zdravilo proti črevesnim zajedavcem).
In a field study, 324 dogs with flea and/or tick infestations were given a single treatment with Nexgard Spectra or a spot-on medicine containing another active substance, pyriprole, that controls fleas and ticks. 
V terenski študiji je 324 psov z infestacijami z bolhami in/ali klopi prejelo bodisi enojni odmerek zdravila Nexgard Spectra bodisi zdravilo za kožni nanos z učinkovino piriprol, ki nadzoruje število bolh in klopov.
How does Nexgard Spectra work? 
Kako zdravilo Nexgard Spectra deluje?
All the dogs treated with Nexgard Spectra were free of eye worm at day 180 compared to 43% in the afoxolaner-treated group. 
Po 180 dneh noben od psov, ki so prejemali zdravilo Nexgard Spectra, ni bil okužen z očesnim črvom, v primerjavi s 43 % v skupini, ki je prejemala samo afoksolaner.
In order to be exposed to afoxolaner, fleas and ticks must attach to the skin and commence feeding on the dog's blood. 
Da bi bili bolhe in klopi izpostavljeni afoksolanerju, se morajo pritrditi na kožo in se začeti hraniti s krvjo psa. Afoksolaner ubije bolhe, preden izležejo jajčeca, s čimer pomaga zmanjšati kontaminacijo okolice psa.
In a field study, 19 dogs with demodectic mange were treated with Nexgard Spectra monthly on three occasions. 
V terensko študijo je bilo vključenih 19 psov z garjavico vrste Demodex canis, ki so prejeli zdravilo enkrat mesečno tri mesece zapored.
In a field study, 27 dogs with sarcoptic mange were treated with Nexgard Spectra monthly for two months. 
Terenska študija je vključevala 27 psov z garjavico vrste Sarcoptes Scabiei, ki so prejeli zdravilo enkrat mesečno dva meseca zapored.
How is Nexgard Spectra used? 
Kako se zdravilo Nexgard Spectra uporablja?
Treatment for fleas and ticks should be repeated at monthly intervals during the flea or tick seasons; Nexgard Spectra can be used as part of the seasonal treatment of fleas and ticks in dogs infected with gut worms. 
Zdravilo Nexgard Spectra se lahko uporablja kot del sezonskega zdravljenja infestacij z bolhami in klopi pri psih, okuženih s črevesnimi zajedavci.
Nexgard Spectra reduced worm counts by 95% at 90-92 days after treatment. 
90-92 dni po zdravljenju zmanjšalo število glist za 95 %.
A single dose of Nexgard Spectra is given to treat gut worms. 
Za zdravljenje okužbe s črevesnimi zajedavci se daje enkraten odmerek zdravila Nexgard Spectra.
Demodectic mange 
Zdravljenje demodikoze (ki jo povzroča Demodex canis)
Oral explanations were heard on 10 October 2007. 
Ustna pojasnila so bila podana 10. oktobra 2007.
The applicability of the following question of the VICH GL6 was considered: 
Preučena je bila uporabnost naslednjega vprašanja VICH GL6:
3 Conclusions and recommendations 
Zaključki in priporočila
A white homogenous paste 
Bela homogena pasta
These points were included in the List of Questions that the Committee for Veterinary Medicinal Products adopted on 11 July 2007. 
Te točke so bile vključene v seznam vprašanj, ki jih je Odbor za zdravila za uporabo v veterinarski medicini sprejel 11. julija 2007.
No risk mitigation measures are considered appropriate. 
Nikakršni ukrepi za zmanjšanje tveganja niso ocenjeni kot primerni.
Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to the CVMP. 
V skladu s členom 33(4) Direktive Sveta 2001/82/ES, kakor je bila spremenjena, je bila zadeva napotena na CVMP.
Czech Republic As above 
Češka republika Kot zgoraj
Ivermectin-containing products are widely used in these species. 
Zdravila, ki vsebujejo ivermektin, se pri teh vrstah široko uporabljajo.
However some consideration to this is given on the document that can be summarised as follows: 
Vendar pa je bil v zvezi s tem podan določen zadržek, ki ga je mogoče povzeti na naslednji način:
The referral procedure started on 11 July 2007. 
Postopek napotitve se je pričel 11. julija 2007.
The Marketing Authorisation Holder submitted written responses to the List of Questions on 12 September 2007. 
Imetnik dovoljenja za promet je predložil pisne odgovore na seznam vprašanj 12. septembra 2007.
The referral relates to the concerns raised by Germany that this veterinary medicinal product may present a potential serious risk to public health on the following grounds: 
Napotitev se nanaša na zadržke Nemčije, da utegne to zdravilo za uporabo v veterinarski medicini predstavljati potencialno resno tveganje za javno zdravje, in sicer na iz naslednjih razlogov:
In addition, he considers that since this is a generic, there will not be an additional risk to the environment. 
Nadalje meni še, da zdravilo zaradi svoje generične narave ne bo predstavljalo dodatnega tveganja za okolje.
The product under referral is intended for horses only. 
Zdravilo, za katero je bil sprožen napotitveni postopek, je namenjeno samo za konje.
The List of Questions was sent to the Marketing Authorisation Holder. 
Seznam vprašanj je bil predložen imetniku dovoljenja za promet.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved at day 90 during the Coordination group procedure. 
Veljavni Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo so končne različice, potrjene 90. dan v okviru postopka Skupine za usklajevanje.
• An updated Environmental Risk Assessment 
• posodobljeno oceno tveganja za okolje
One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight). 
Ena brizga paste na 100 kg telesne mase (na osnovi priporočenega odmerka 200 mikrogramov ivermektina na kg telesne mase).
Although oral paste is not used in major species (cattle, sheep, pigs), oral forms exist. 
Čeprav se peroralna pasta ne uporablja pri pomembnejših vrstah (govedo, ovce, prašiči), so peroralne oblike na voljo.
On the basis of the grounds for referral, the points considered by the CVMP were: 
Na osnovi podlage za napotitev je CVMP obravnaval naslednje točke:
Despite this, Step 16 of the Phase I decision tree would indicate that a Phase II assessment is required for a product of this nature i.e. ecto/endoparasiticide for major species. 
Ne glede na to bi iz koraka 16 odločitvenega drevesa za fazo I sledilo, da je faza II ocenjevanja za tovrstno zdravilo, tj. ekto-/endoparaziticid za pomembnejše vrste, potrebna.
Ecomectin 18.7 mg/g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids: Parascaris equorum, Pinworms: Oxyuris equim, Neck threadworms: Onchocerca spp, Stomach bots: Gasterophilus spp 
Zdravilo Ecomectin 18,7 mg/g peroralna pasta za konje je namenjeno za uporabo pri konjih za zdravljenje okužb z nematodi ali artropodi, ki jih povzročajo Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, mali strongilidi (vključno s sevi, odpornimi na benzimidazol): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., askaridi: Parascaris equorum, podančice: Oxyuris equim, nitasti zajedavci iz rodu Onchocerca : Onchocerca spp, trebušni zolji: Gasterophilus spp.
The applicant does not provide a formal justification for exemption of Phase II. 
Predlagatelj ni predložil formalne utemeljitve za izvzetje faze II.
Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/g Oral Paste for Horses. 
Irska je dne 4. julija 2007 obvestila EMEA, da usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v veterinarski medicini (CMD(v)) ni uspela doseči soglasja glede peroralne paste za konje Ecomectin 18,7 mg/g.
The Marketing Authorisation Holder provided the following information: 
Imetnik dovoljenja za promet z zdravilom je predložil naslednje informacije:
2 Information in respect to environmental risk assessment 
Informacije v zvezi z oceno tveganja za okolje
The time frame agreed by the CVMP on 11 July 2007 was 58 days. 
CVMP je dne 11. julija 2007 določil časovni okvir 58 dni.
• The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment. 
• celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD(v) v zvezi z oceno tveganja za okolje.
Question 4 - Is the VMP intended for use in a minor species that is reared and treated similarly to a major species for which an EIA (Environmental Impact Assessment) already exists? 
Vprašanje 4 - Ali je zdravilo za uporabo v veterinarski medicini namenjeno za uporabo pri manj pomembni vrsti, ki se vzreja in goji podobno kot pomembnejša vrsta, za katero presoja vplivov na okolje (EIA, Environmental Impact Assessment) že obstaja?
PECSOIL- Intensively reared animals = 1.036 µg.kg-1 
PECTLA- živali v intenzivni reji = 1,036 µg.kg-1
Based on this, the applicant argued that the horse should be classed as “minor use/minor species” and that no Phase II risk assessment is required. 
Na podlagi tega je predlagatelj mnenja, da bi konji morali soditi v skupino »manjše uporabe/manj pomembne vrste« ter da faza II ocenjevanja tveganja ni potrebna.
The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-corr). 
Izračunana je bila PEC (predvidena koncentracija v okolju) v prsti za živali v intenzivni reji in pašne živali, v skladu s smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-popr.).
No adequate data for Tier B were provided by the applicant to assess the long-term effects on dung fauna organisms caused by the use of the product. 
Predlagatelj ni predložil ustreznih podatkov za stopnjo B, ki bi omogočali oceno dolgoročnih učinkov uporabe zdravila na organizme, prisotne v gnoju.
For two soil exposure scenarios the PECSOIL values did not exceed the 100 µg/kg threshold value as stated in the VICH Guideline for Phase I assessments of veterinary medicines. 
Pri teh dveh scenarijih izpostavljenosti vrednosti PECTLA nista presegli mejne vrednosti 100 µg/kg, kot je navedeno v smernici VICH za fazo I ocenjevanja za zdravila za uporabo v veterinarski medicini.
A separate file for justification of exemption from phase II was not specifically given. 
Ločena dokumentacija za utemeljitev izvzetja iz faze II ni bila posebej predložena.
The Marketing Authorisation Holder provided an updated environmental risk assessment. 
Imetnik dovoljenja za promet z zdravilom je predložil posodobljeno oceno tveganja za okolje.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S) 
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE IN IMETNIK/PREDLAGATELJ(I) DOVOLJENJA ZA PROMET Z ZDRAVILOM
2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II 
2.1 Posodobljena ocena tveganja za okolje v skladu s smernicami CVMP v zvezi s to tematiko, vključno z morebitno utemeljitvijo za izvzetje faze II
Ecomectin 18.7 mg/g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/82, as amended. 
Ecomectin 18,7 mg/g peroralna pasta za konje spada med generična zdravila, za katera pa se zdaj v skladu z Direktivo 2001/82, kakor je bila spremenjena, zahteva priprava ocene tveganja za okolje.
The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed. 
Imetnik dovoljenja za promet z zdravilom meni, da so bile smernice v prvi vrsti izdelane za nove molekule, katerih tveganje za okolje še ni bilo opredeljeno, in da slednje ne velja za primer veterinarskih zdravil, vsebujočih ivermektin, ki se na široko uporabljajo po vsem svetu že skoraj 25 let, sicer bi bili resnična tveganja ali škodljivi učinki na okolje, ki bi jih bilo mogoče pripisati veterinarskim zdravilom na osnovi invermektina, doslej že opaženi.
The applicant considers that the level of use in horses in terms of animal numbers and dose level, compared to other pasture animals (cattle and sheep) is low and that consequently the use in the horse will have limited impact on the environment. 
Predlagatelj meni, da je stopnja uporabe zdravila pri konjih, kar se tiče števila živali in višine odmerkov, v primerjavi z drugimi pašnimi živalmi (govedo in ovce) majhna, zaradi česar bo imela uporaba tega zdravila pri konjih zgolj omejen učinek na okolje.
PECSOIL- Pasture animals = 0.48 µg.kg-1 
PECTLA- pašne živali = 0,48 µg.kg-1
Oral Paste. 
Peroralna pasta.
The paste is given by oral route. 
Pasta se daje peroralno.
Strength Animal speciesFrequency and route of administration 
Živalska vrsta Pogostost in pot
The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment; 
Imetnik dovoljenja za promet mora predložiti celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD(v) v zvezi z oceno tveganja za okolje;