FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtske oblike, jakosti zdravil za uporabo v veterinarski medicini, živalske vrste, način dajanja zdravila, vlagatelj v državah članicah
English: Scientific justifications were provided for the cases of deviations from guidelines and a number of peer reviewed publications were submitted.
Slovenian: Za primere odstopanja od smernic je predložil znanstvene utemeljitve in številne strokovno pregledane objave.
English: A new study was carried out on earthworms according to the recommended OECD guideline and a predicted no effect concentration (PNEC) was derived using the accepted assessment factor (10).
Slovenian: Nova študija, izvedena na deževnikih v skladu s priporočeno smernico OECD in predvideno koncentracijo brez učinka (PKBU), je bila izpeljana z uporabo sprejetega faktorja ocenjevanja (10).
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Slovenian: Ostanki deltametrina bodo v okolje vneseni z neposrednim izločanjem na pašnikih.
English: Data from an acceptable study gave a bioconcentration factor of 510 l/kg which is below the value of 2000 l/kg which would indicate a potential to bioaccumulate.
Slovenian: Po podatkih sprejemljive študije je bil bioakumulacijski faktor 510 l/kg, kar je pod vrednostjo 2 000 l/kg, ki bi lahko nakazovala možnost kopičenja v organizmih.
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Slovenian: Dodajte, kjer je primerno, »Deltametrin je strupen za vodne organizme in medonosne čebele ter se lahko kopiči v usedlini.«
English: The RQ values for surface water were <1 for all target animal types.
Slovenian: Vrednosti količnika tveganja za površinske vode so bile za vse ciljne vrste živali manj kot 1.
English: 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.
Slovenian: Predložena je bila ocena tveganja za okolje v skladu s smernicami VICH in CVMP, ki je vsebovala objavljene študije in študije po naročilu predlagatelja ter je obravnavala vse vidike tveganja za okolje.
English: Furthermore, appropriate risk mitigation measures (RMMs) were considered missing in the product information as a consequence of the identified unacceptable risk to aquatic organisms.
Slovenian: Poleg tega sta bili mnenja, da v informacijah o zdravilu manjkajo ustrezni ukrepi za zmanjšanje tveganja zaradi ugotovljenega nesprejemljivega tveganja za vodne organizme.
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 Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the products.
Slovenian: Ta napotitev v skladu s členom 33(4) Direktive 2001/82/ES je bila izvedena zaradi pomislekov, da predlagatelj ni zadovoljivo dokazal varnosti za okolje za zdravili Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo, ker ni predložil ključnih podatkov, brez katerih ni mogoče sklepati, ali je zdravilo varno za okolje.
English: Published data from a field study using a pour-on deltamethrin product indicated that the effects of deltamethrin can persist for a number of weeks and have the potential to affect dung insect populations in some circumstances.
Slovenian: Objavljeni podatki terenske študije o uporabi kožnega poliva z deltametrinom so pokazali, da se lahko učinki deltametrina ohranijo še kar nekaj tednov in da lahko v določenih okoliščinah vplivajo na populacije žuželk, ki se hranijo z iztrebki.
English: No degradation rate for deltamethrin in sediment was required in order to complete the ERA, but some information in the published literature suggests that in some sediments degradation occurs with a half-life in soil of about 10 days (Åkerblom et al. 2008)4.
Slovenian: Stopnja razgradnje za deltametrin v usedlinah ni bila potrebna za dokončanje ocene tveganja za okolje, vendar pa nekatere informacije v objavljeni literaturi nakazujejo, da je v nekaterih usedlinah razpolovna doba približno 10 dni (Åkerblom in drugi 2008)4.
English: 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.
Slovenian: Da bi predlagatelj odpravil pomisleke, izražene v napotitvi, je predložil oceno tveganja za okolje v skladu s smernicama VICH GL 61 in GL 382 ter smernico CVMP v podporo smernicama VICH GL 6 in GL 38 (EMEA/CVMP/ERA/418282/2005)3.
English: As the PECgroundwater was below 0.1 µg/l no further assessment for the water compartment was required.
Slovenian: Ker je bila vrednost predvidene koncentracije v podtalnici manj kot 0,1 µg/l, nadaljnja ocena za vodno okolje ni bila potrebna.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands who considered no acceptable data in the environmental risk assessment has been provided on: n-octanol:water partition coefficient (KOW); soil adsorption coefficient (KOC); soil degradation; bioaccumulation (BCF); toxicity to dung insects, and therefore the environmental risk assessment cannot be finalised.
Slovenian: Med decentraliziranim postopkom sta Nemčija in Nizozemska ugotovili možnost resnega tveganja, saj sta menili, da pri oceni tveganja za okolje niso bili zagotovljeni sprejemljivi podatki o: porazdelitvenem koeficientu n-oktanol/voda (KOW), koeficientu adsorpcije v tla (KOC), degradaciji tal, kopičenju v organizmih (BCF) in toksičnosti za žuželke, ki se hranijo z iztrebki, ter da zato ni mogoče dokončati presoje tveganja za okolje.
English: The applications in question, submitted via the decentralised procedure, are generic applications according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose authorised in the United Kingdom.
Slovenian: Zadevni vlogi, predloženi po decentraliziranem postopku, sta vlogi za generična zdravila v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, v zvezi z referenčnima zdraviloma Pfizer insekticid v polivu 1 % w/v dermalna raztopina in insekticid za kožni nanos 1% w/v večodmerna dermalna raztopina, odobrenima v Združenem kraljestvu.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as CMS.
Slovenian: Za zdravilo za kožni nanos pa so zadevne države članice Belgija, Francija, Nemčija in Nizozemska.
English: New acute OECD studies were carried out on aquatic organisms followed by an OECD chronic study with daphnia.
Slovenian: Na vodnih organizmih so bile opravljene nove študije OECD o akutni izpostavljenosti, ki jim je sledila študija OECD o dolgotrajni izpostavljenosti na vodni bolhi.
English: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
Slovenian: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Slovenian: Ker je aktivna snov sredstvo proti zunanjim zajedavcem, je bila predstavljena ocena tveganja za okolje za fazo II.
English: Acceptable data on the acute toxicity of deltamethrin to dung fly larvae and adult beetles were provided which indicated that RQ values for dung insects were in the order of 90 - 10 000.
Slovenian: Predloženi so bili sprejemljivi podatki o akutni strupenosti deltametrina za ličinke muhe in odraslih hroščev, ki se prehranjujejo z iztrebki, in ti podatki so pokazali, da so bile vrednosti količnika tveganja pri teh žuželkah v redu velikosti med 90 in 10 000.
English: Using these data PNECs were derived using the appropriate assessment factors.
Slovenian: Z uporabo teh podatkov so bili izpeljani podatki o predvideni koncentraciji brez učinka na podlagi ustreznih faktorjev ocenjevanja.
English: The high soil adsorption coefficient (KOC, expressed as logKOC) of >4.2 suggests that any deltamethrin which enters the aquatic environment will move to the sediment.
Slovenian: Visok koeficient adsorpcije v tla (KOC, izražen kot logKOC), in sicer več kot 4,2, nakazuje, da bo šel ves dektametrin, ki se vnaša v vodno okolje, v usedline.
English: An ERA was provided for the Deltanil products, which was in accordance with VICH and CVMP guidelines.
Slovenian: Za zdravilo Deltanil je bila predložena ocena tveganja za okolje, ki je bila v skladu s smernicami VICH in CVMP.
English: Consequently in order to mitigate the risk for dung insects RMMs were included in the SPC in sections 4.5.iii and 5 (Environmental properties).
Slovenian: iztrebki, so bili posledično v Povzetku glavnih značilnosti zdravila v poglavjih 4.5.iii in 5 (Okoljske značilnosti) vključeni ukrepi za zmanjšanje tveganja.
English: 5 Environmental properties
Slovenian: 5 Okoljski podatki
English: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
Slovenian: guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf.
English: The adsorption/desorption of deltamethrin was determined by the HPLC method which showed that deltamethrin was expected to be non-mobile in soil.
Slovenian: Adsorpcija/desorpcija deltametrina je bila določena z visoko ločljivo tekočinsko kromatografijo (HPLC), ki je pokazala, da naj deltametrin ne bi bil mobilen v tleh.
English: These PNECs were compared with the PEC values (calculated using agreed methods) for surface water exposed via drainage through soil, via direct excretion by cattle and via loss from the fleece of sheep.
Slovenian: Podatki o predvideni koncentraciji brez učinka so bili primerjani z vrednostmi predvidene koncentracije v okolju (izračunanimi na dogovorjen način) za površinske vode, izpostavljene s pronicanjem vode skozi tla, prek neposrednega izločanja goveda in z odpadanjem volne pri ovcah.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Deltanil Pour-On and Spot-on products shows that the products are not expected to pose a risk for the environment when used as recommended in the product information including the recommended RMMs.
Slovenian: CVMP je po preučitvi vseh pisno predloženih podatkov sklenil, da ocena tveganja za okolje za kožni poliv in kožni nanos Deltanil kaže, da naj zdravilo ne bi povzročilo tveganja za okolje, če se uporablja po priporočilu v informacijah o zdravilu, vključno s priporočenimi ukrepi za zmanjšanje tveganja.
English: Amendments in the relevant sections of the Summaries of Product Characteristics and package leaflets
Slovenian: Spremembe poglavij v povzetkih glavnih značilnosti zdravila ter v navodilih za uporabo
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Slovenian: Na podlagi ocene tveganja za okolje predlagatelj ni predlagal drugih ukrepov za zmanjšanje tveganja.
English: The benefit of the products is that treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs can be carried out using the products.
Slovenian: Zdravilo se uporablja za zdravljenje in preprečevanje napadov uši in muh na govedu, ugrizov klopov, uši, muhe melophagus ovinus in mesarskih muh na ovcah ter klopov in uši pri jagnjetih.
English: Comparison of the predicted environmental concentration (PEC) value for soil with the PNEC showed that the RQ for the soil compartment was <1 and no further assessment was required.
Slovenian: Primerjava vrednosti predvidene koncentracije v okolju (PKO) za tla s predvideno koncentracijo brez učinka je pokazala, da je vrednost količnika tveganja za tla manj kot 1, zato nadaljnja ocena ni bila potrebna.
English: As deltamethrin has a n-octanol/water partition coefficient (KOW, expressed as logKOW) of >5.1, its bioaccumulation potential, potential for being considered a persistent, bioaccumulative and toxic (PBT) compound and secondary poisoning were addressed as required by the VICH and CVMP guidelines.
Slovenian: Ker ima deltametrin porazdelitveni koeficient n-oktanol/voda (KOW, izražen kot logKOW) več kot 5,1, so se v skladu s smernicami VICH in CVMP obravnavali njegova možnost kopičenja v organizmih, možnost, da se šteje za obstojno spojino, se kopiči v organizmih in je strupena, ter možnost sekundarne zastrupitve.
English: Package leaflet:
Slovenian: Navodilo za uporabo/vloženi listič:
English: As a result of this referral it was considered that due to the high adsorption coefficient (KOC) of deltamethrin the following environmental information should also be added to the previously agreed warning sentence in the SPC (section 5 Environmental Properties) and the package leaflet (section 15 Environmental Properties) "...and may accumulate in sediment".
Slovenian: Po mnenju odbora bi bilo tako treba zaradi visokega adsorpcijskega faktorja (KOC) deltametrina prej dogovorjenemu opozorilu v povzetku glavnih značilnosti zdravila (oddelek 5 Okoljske značilnosti) in navodilu za uporabo (oddelek 15 Okoljske značilnosti) dodati naslednjo okoljsko informacijo „in se lahko kopiči v usedlinah“.
English: Applicant
Slovenian: vlagatelj
English: Evaluation of secondary poisoning showed the risk quotient (RQ) values for terrestrial and aquatic predators were <1 and further assessment was not required.
Slovenian: Ocena možnosti sekundarne zastrupitve je pokazala, da je vrednost količnika tveganja za zemeljske in vodne plenilce manj kot 1, zato nadaljnje ocene niso bile potrebne.
English: A screening for PBT properties as required by the CVMP guidelines indicated that deltamethrin did not fulfil the criteria for either 'P' or 'B' although it is considered to be 'T'.
Slovenian: Presejevanje za značilnosti, da je „obstojen, se kopiči v organizmih in je strupen“, kot se zahteva s smernicami CVMP, je pokazalo, da deltametrin ni izpolnjeval meril za zdravilo, ki je “obstojno” ali “se kopiči v organizmu”, čeprav se šteje za “strupeno”.
English: Strength Pharmaceutical form
Slovenian: Farmacevtska oblika živalske vrste
English: The RMMs and warnings in the Summary of Product Characteristics (SPC) and package leaflet address the risk to dung insects by advising on the frequency of re-treatments and the duration of deltamethrin excretion.
Slovenian: Tveganje za žuželke, ki se hranijo z iztrebki, se je obravnavalo v ukrepih za zmanjšanje tveganja in opozorilih, povzetku glavnih značilnosti zdravila in navodilih za uporabo z nasveti o pogostosti ponovnega zdravljenja in trajanju izločanja deltametrina.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle with amendment to the Summaries of Product Characteristics and package leaflets of the reference Member State.
Slovenian: Zato je odbor CVMP priporočil izdajo dovoljenj za promet z zdraviloma Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo, s spremembo referenčne države članice v povzetkih glavnih značilnosti zdravila in navodilih za uporabo.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin, a synthetic pyrethroid.
Slovenian: Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo, vsebujeta sintetični piretroid deltametrin.
English: Evaluation of the benefit-risk balance
Slovenian: Ocenjevanje razmerja med tveganji in koristmi
English: A risk for dung insects was identified by the ERA and RMMs were proposed to address the risk.
Slovenian: Z oceno tveganja za okolje je bilo ugotovljeno tveganje za žuželke, ki se hranijo z iztrebki, za odpravo tveganja pa so bili predlagani ukrepi za njegovo zmanjšanje.
English: Deltamethrin was shown to have a half-life in soil of 72 days based on acceptable published data.
Slovenian: Na podlagi sprejemljivih objavljenih podatkov je razpolovna doba deltametrina v tleh 72 dni.
English: ENVIRONMENTAL PROPERTIES
Slovenian: OKOLJSKI PODATKI
English: Additionally, RMMs have been considered and proposed for the risk identified for dung insects.
Slovenian: Poleg tega so bili za ugotovljena tveganja za žuželke, ki se hranijo z iztrebki, preučeni in predlagani ukrepi za zmanjšanje
English: Deltamethrin is used topically (dip, spray or pouron) for the control of ectoparasites in cattle and sheep.
Slovenian: Ta se uporablja lokalno (kopel, pršilo ali poliv) za zatiranje zunanjih zajedavcev pri govedu in ovcah.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Slovenian: Znanstveni zaključki in razlogi za izdajo dovoljenja za promet z zdraviloma Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo
English: Overall summary of the scientific evaluation of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Deltanil 10 mg/ml, raztopine za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopine za kožni nanos za govedo
English: Overall deltamethrin was not considered to be a PBT compound.
Slovenian: Na splošno se deltametrin ne šteje za spojino, ki je obstojna, se kopiči v organizmu in je strupena.
English: The benefit-risk balance is considered positive for both Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Slovenian: Razmerje med koristmi in tveganji za zdravili Deltanil 10 mg/ml, raztopino za poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo, se šteje za ugodno.
English: Grounds for the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Slovenian: Razlogi za izdajo dovoljenj za promet z zdraviloma Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo
English: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Slovenian: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCIJA
English: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Slovenian: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCIJA
English: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Slovenian: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCIJA
English: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Slovenian: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCIJA
English: No further assessment of risks to surface water and sediment was necessary and no RMMs were needed.
Slovenian: Na podlagi sprejemljivih objavljenih podatkov za vrste v usedlinah je bila vrednost količnika tveganja manj kot 1, zato niso bile potrebne nadaljnje ocene tveganja za površinske vode in usedline niti ukrepi za zmanjšanje tveganj.
English: What measures are being taken to ensure the safe and effective use of Halaven?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Halaven?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Halaven, veljavno po vsej Evropski uniji, izdala 17. marca 2011.
English: The full EPAR for Halaven can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Halaven je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Halaven.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Halaven.
English: What benefit has Halaven shown during the studies?
Slovenian: Kakšne koristi je zdravilo Halaven izkazalo med študijami?
English: Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.
Slovenian: Ženske v skupini, ki je prejemala zdravilo Halaven, so živele povprečno 13,1 meseca v primerjavi z 10,6 meseca v skupini, ki je prejemala druga zdravila.
English: Halaven must not be used in women who are breastfeeding.
Slovenian: Zdravilo Halaven se ne sme uporabljati pri ženskah, ki dojijo.
English: Other information about Halaven
Slovenian: Druge informacije o zdravilu Halaven
English: The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.
Slovenian: Najpogostejši neželeni učinki zdravila Halaven (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizka raven nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam), levkopenija (nizko število belih krvnih celic), anemija (nizko število rdečih krvnih celic), zmanjšan tek, periferna nevropatija (poškodbe živcev v okončinah, ki povzročajo otopelost, ščemenje ali zbadanje), glavobol, dispneja (oteženo dihanje), kašelj, navzeja (slabost), zaprtost, driska, bruhanje, alopecija (izguba las), bolečine v mišicah in sklepih ali bolečine v hrbtu in okončinah, utrujenost, pireksija (povišana telesna temperatura) in izguba telesne mase.
English: The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Slovenian: Izračunani odmerek se daje kot 2- do 5-minutna intravenska injekcija 1. in 8. dan vsakega cikla.
English: Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.
Slovenian: Varnost pri tej populaciji zdravnikov je bila sprejemljiva in podobna tisti, ki so jo opazili pri obolelih za rakom dojke.
English: A risk management plan has been developed to ensure that Halaven is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Halaven je bil pripravljen načrt obvladovanja tveganj.