FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects and restrictions with Prolia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Prolia glejte navodilo za uporabo.
English: Bone loss in men receiving treatment for prostate cancer
Slovenian: Izguba kostne mase pri moških, ki se zdravijo zaradi raka prostate
English: Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Slovenian: Zdravilo Prolia se je pokazalo kot učinkovitejše od placeba pri zdravljenju izgube kostne mase v eni glavni študiji, v katero je bilo vključenih 1 468 moških, ki so se zdravili zaradi raka prostate in pri katerih je bilo tveganje za zlom večje.
English: • bone loss in men receiving treatment for prostate cancer that increases their risk of fracture.
Slovenian: • izgube kostne mase pri moških, ki se zdravijo zaradi raka prostate, kar povečuje tveganje za zlome.
English: Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Slovenian: Zdravilo Prolia se je pri povečevanju kostne gostote pokazalo kot učinkovitejše od risedronata (difosfonatnega zdravila) v eni glavni študiji, v katero je bilo vključenih 795 odraslih, zdravljenih s kortikosteroidnimi zdravili.
English: In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
Slovenian: Zdravilo Prolia pri ženskah po menopavzi zmanjšuje tveganje za zlome hrbtenice in drugih kosti v telesu, vključno s kolkom;
English: Bone loss in adults receiving long-term corticosteroid therapy
Slovenian: Izguba kostne mase pri odraslih, ki se dolgotrajno zdravijo s kortikosteroidi
English: In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Slovenian: Pri moških, ki so jemali zdravilo Prolia, se je kostna gostota po enem letu zdravljenja povečala za 5,7 %, pri moških, ki so jemali placebo, pa za 0,9 %.
English: How does Prolia work?
Slovenian: Kako zdravilo Prolia deluje?
English: In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Slovenian: Pri bolnikih, ki so se pred študijo s kortikosteroidi zdravili več kot tri mesece, se je gostota kosti v ledvenem delu hrbtenice po enem letu zdravljenja z zdravilom Prolia povečala za 3,6 %, pri bolnikih, zdravljenih z risedronatom, pa za 2,0 %.
English: In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
Slovenian: V prvi študiji je po treh letih zdravljenja do novega zloma prišlo pri 2 % žensk, ki so jemale zdravilo Prolia, in pri 7 % žensk, ki so jemale placebo.
English: After 2 years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo.
Slovenian: Po dveh letih se je pri moških, ki so jemali zdravilo Prolia, povečala gostota kosti v ledvenem delu hrbtenice in je bila za 7 % večja kot pri tistih, ki so jemali placebo.
English: In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Slovenian: Pri bolnikih, ki so se pred študijo s kortikosteroidi zdravili največ tri mesece, se je gostota kosti v ledvenem delu hrbtenice po enem letu zdravljenja z zdravilom Prolia povečala za 3,1 %, pri bolnikih, zdravljenih z risedronatom, pa za 0,8 %.
English: Women who took Prolia had higher bone density (a measure of how strong the bones are) in the lumbar (lower) spine after 1 year of treatment than women on placebo.
Slovenian: Ženske, ki so jemale zdravilo Prolia, so imele po enem letu zdravljenja večjo kostno gostoto (merilo jakosti kosti) v ledvenem delu hrbtenice kot ženske, ki so jemale placebo.
English: Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Slovenian: Zdravilo Prolia se daje enkrat na šest mesecev v obliki 60-miligramske injekcije v podkožje stegna, trebuha ali zgornjega dela roke.
English: Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
Slovenian: V dveh glavnih študijah, v katere je bilo skupno vključenih več kot 8 000 žensk po menopavzi z osteoporozo, se je pokazalo, da je zdravilo Prolia pri zmanjševanju zlomov učinkovitejše od placeba (zdravila brez učinkovine).
English: None
Slovenian: Nobenih.
English: This summary was last updated in December 2018.
Slovenian: Ta povzetek je bil nazadnje posodobljen decembra 2018.
English: The local reactions lasted up to 25 days.
Slovenian: Lokalne reakcije so trajale do 25 dni.
English: Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Slovenian: Nadaljnje informacije o zdravilu Zulvac BTV so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Slovenian: Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in Quil-A) za povečanje imunskega odziva.
English: The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
Slovenian: Serotip za uporabo v cepivu se izbere pred proizvodnjo, odvisno od vrste virusa, ki takrat kroži in povzroča bolezen.
English: A booster is required after 12 months.
Slovenian: Obnovitveno cepljenje je potrebno po 12 mesecih.
English: They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Slovenian: Pojavijo se lahko tudi otipljivi podkožni noduli v velikosti 60 cm2, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50 dni.
English: Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Slovenian: Zdravilo Zulvac BTV je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2017.
English: The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Slovenian: Cepivo lahko prepreči prisotnost serotipov 1 ali 8 v krvi in zmanjša ravni serotipa 4.
English: The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Zulvac BTV večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Slovenian: Ime zdravila je bilo 21. februarja 2019 spremenjeno v Zulvac BTV.
English: Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
Slovenian: Upoštevali so tudi terenske podatke o učinkovitosti drugih cepiv proti okužbi z virusom bolezni modrikastega jezika, ki so vsebovala posamezne serotipe ali kombinacijo dveh serotipov.
English: The withdrawal period for meat and milk from sheep and cattle treated with Zulvac BTV is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso in mleko ovac in goveda, cepljenih s cepivom Zulvac BTV, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Slovenian: Cepivo je na voljo v obliki suspenzije za injiciranje, njegovo predpisovanje in izdaja pa je le na recept.
English: The vaccine contains inactivated (killed) bluetongue virus.
Slovenian: Cepivo vsebuje inaktivirane (uničene) viruse modrikastega jezika.
English: Protection lasts for one year for both serotype 1 and 8.
Slovenian: Zaščita traja eno leto za serotipa 1 in 8.
English: For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe cepiva Zulvac BTV glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: The vaccine is given as two injections under the skin for sheep and in the muscle for cattle.
Slovenian: Cepivo se daje v obliki dveh injekcij v podkožje pri ovcah in v mišico pri govedu.
English: In most cases the reactions are diffuse swellings at the injection site which last no longer than one week.
Slovenian: V večini primerov je eden od neželenih učinkov difuzna oteklina na mestu injiciranja, ki ne traja več kot sedem dni.
English: Zulvac BTV is a vaccine.
Slovenian: Zdravilo Zulvac BTV je cepivo.
English: The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Slovenian: Najpogostejši neželeni učinki zdravila Zulvac BTV pri govedu (ki lahko prizadenejo več kot 1 žival od 10) so lokalne reakcije na mestu injiciranja in kratkotrajno zvišanje telesne temperature do 2,7 °C v dveh dneh po cepljenju.
English: The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Slovenian: Prva injekcija se daje od 6 tednov starosti za ovce in od starosti 12 tednov za govedo.
English: When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Slovenian: Za ovce se uporablja cepivo, ki vsebuje enega od naslednjih treh sevov cepiva: serotip 1 (BTV-1), serotip 4 (BTV-4) in serotip 8 (BTV-8).Če se uporablja pri govedu, cepivo vsebuje bodisi serotip 1 ali serotip 8.
English: The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Slovenian: Najpogostejši neželeni učinki cepiva Zulvac BTV pri ovcah (ki lahko prizadenejo več kot 1 žival od 10) so prehodno povišanje telesne temperature (do največ 1,6 ˚C) v dveh dneh po cepljenju in lokalne reakcije na mestu injiciranja.
English: An overview of Zulvac BTV and why it is authorised in the EU
Slovenian: Pregled zdravila Zulvac BTV in zakaj je odobreno v EU
English: Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Slovenian: Zdravilo Zulvac BTV je cepivo, ki se uporablja pri ovcah in govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
English: A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Slovenian: Laboratorijske študije z jagnjeti, cepljenimi s serotipom 4, so pokazale, da je cepivo za najmanj 12 mesecev znižalo ravni serotipa 4 v krvi, medtem ko so študije s serotipoma 1 in 8 pokazale, da posamezna serotipa po enem letu nista bila več prisotna.
English: Why is Zulvac BTV authorised in the EU?
Slovenian: Zakaj je zdravilo Zulvac BTV odobreno v EU?
English: Further laboratory studies showed protection lasts for one year for each serotype.
Slovenian: Dodatne laboratorijske študije so pokazale, da zaščita pri vsakem serotipu traja eno leto.
English: What is Zulvac BTV and what is it used for?
Slovenian: Kaj je zdravilo Zulvac BTV in za kaj se uporablja?
English: What benefits of Zulvac BTV have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zulvac BTV izkazalo v študijah?
English: For cattle protection starts 15 days after the initial course of two injections for serotype 1 whilst protection starts 25 days after the initial course of two injections for serotype 8.
Slovenian: Pri govedu se zaščita pojavi 15 dni po začetnem sklopu dveh injekcij za serotip 1, medtem ko se za serotip 8 zaščita pojavi 25 dni po začetnem sklopu dveh injekcij.
English: Further laboratory studies showed protection lasts for one year for the respective serotypes.
Slovenian: Dodatne laboratorijske študije so pokazale, da zaščita pri zadevnih serotipih traja eno leto.
English: What are the risks associated with Zulvac BTV?
Slovenian: Kakšna tveganja so povezana z zdravilom Zulvac BTV?
English: Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Slovenian: Cepivo Zulvac BTV vsebuje inaktivirani virus bolezni modrikastega jezika, ki ne povzroča bolezni.
English: Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype.
Slovenian: Laboratorijske študije so bile opravljene s posameznimi serotipi 1, 4 in 8 ter s kombinacijo vseh treh serotipov pri ovcah ter so pokazale, da se je zaščita pojavila tri tedne po zaključenem začetnem sklopu dveh injekcij za vsak serotip.
English: When it is given to sheep or cattle, their immune system recognises
Slovenian: Ko ovce ali govedo prejmejo cepivo, imunski sistem prepozna virus kot „tujek“ in začne proti njemu tvoriti protitelesa.
English: Other information about Zulvac BTV?
Slovenian: Druge informacije o zdravilu Zulvac BTV
English: Laboratory studies were conducted with the individual serotypes 1 and 8 in cattle which showed that protection starts 15 days after completion on the initial vaccination course of two injections for serotype 1 and 25 days after completion of the initial vaccination course for serotype 8.
Slovenian: Pri govedu so bile izvedene laboratorijske študije s posameznimi serotipi 1 in 8, ki so pokazale, da se je zaščita pojavila 15 dni po zaključenem začetnem sklopu dveh injekcij za serotip 1 in 25 dni po zaključku začetnega cepljenja za serotip 8.
English: For sheep protection starts 3 weeks after the initial course of two injections and lasts for one year.
Slovenian: Zaščita je učinkovita od tretjega tedna po prvem sklopu z dvema injekcijama in traja eno leto.
English: Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8.
Slovenian: Cepivo Zulvac BTV vsebuje enega od serotipov bolezni modrikastega jezika, in sicer 1, 4 ali 8.
English: How does Zulvac BTV work?
Slovenian: Kako zdravilo Zulvac BTV deluje?
English: How is Zulvac BTV used?
Slovenian: Kako se zdravilo Zulvac BTV uporablja?
English: • the CHMP reviewed the available data submitted by the Applicant
Slovenian: • odbor CHMP je pregledal razpoložljive podatke, ki jih je predložil predlagatelj,
English: Overall summary of the scientific evaluation of Simvastatin Vale and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Simvastatin Vale in povezanih imen (glejte Prilogo I)
English: The CHMP noted that the proposed formulations are largely identical qualitatively and quantitatively and are manufactured according to the same process.
Slovenian: Odbor CHMP je zabeležil, da so predlagane oblike kvalitativno in kvantitativno v glavnem identične in da so proizvedene z enakim postopkom.
English: Finally, the CHMP considered the bioanalytical method used to be sufficiently validated and in line with the bioequivalence guideline.
Slovenian: Nazadnje je odbor CHMP menil, da je bila uporabljena bioanalitična metoda zadovoljivo potrjena in v skladu s smernicami biološke enakovrednosti.
English: The CHMP also evaluated the in vitro dissolution data, noting that both products showed rapid and high dissolution levels at pH 7 and that solubility was therefore unlikely to be a limiting factor.
Slovenian: Odbor je prav tako ocenil podatke raztapljanja in vitro ter zabeležil, da sta obe zdravili pokazali hitre in visoke stopnje raztapljanja pri pH 7 in da topnost zato najverjetneje ne bo omejitveni dejavnik.
English: The CHMP considered that the pharmacokinetics of simvastatin are fully linear across the therapeutic dose range, that simvastatin is well absorbed and that no significant differences in absorption between the proposed and the reference product could be identified.
Slovenian: Odbor CHMP je menil, da je farmakokinetika simvastatina popolnoma linearna v razponu terapevtskih odmerkov, da se simvastatin dobro absorbira in da ni bilo mogoče opredeliti nobene pomembne razlike v absorpciji med predlaganim in referenčnim zdravilom.
English: While the CHMP agreed that there was a deviation from the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), which states that for substances with linear pharmacokinetics, bioequivalence should in general be established with the highest strengths, it considered that this deviation should be considered in light of the available data and therefore assessed the Applicant dossier to determine the clinical relevance of the deviation.
Slovenian: Čeprav se je odbor CHMP strinjal, da je prišlo do odklona od Smernic CHMP o raziskavah biološke enakovrednosti (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), v katerih je navedeno, da je treba za snovi z linearno farmakokinetiko biološko enakovrednost v splošnem dokazati za največje jakosti, je odbor menil, da je treba ta odklon upoštevati v okviru razpoložljivih podatkov, in zato ocenil vlagateljevo dokumentacijo, da bi določil klinični pomen odklona.
English: • the CHMP considered that both strengths of the proposed product can be considered bioequivalent to the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Simvastatin Vale and associated names (see Annex I).
Slovenian: • odbor CHMP je menil, da sta obe jakosti predlaganega zdravila biološko enakovredni referenčnemu zdravilu, je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Simvastatin Vale in povezana imena (glejte Prilogo I).
English: • the CHMP considered that the available data allowed extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength
Slovenian: • odbor CHMP je menil, da razpoložljivi podatki omogočajo ekstrapolacijo dokazane biološke enakovrednosti z jakosti 20 mg/5 ml na jakost 40 mg/5 ml,
English: The marketing authorisation application for a generic simvastatin oral suspension to be marketed as Simvastatin Vale 20 mg/5 ml and 40 mg/5 ml and indicated in the treatment of hypercholesterolemia and cardiovascular disease prevention was supported by a single bioequivalence study comparing the 20 mg/5 ml oral suspension to the 20 mg immediate release tablet of the reference product.
Slovenian: Vloga za pridobitev dovoljenja za promet s peroralno raztopino generičnega simvastatina, ki naj bi se tržila kot zdravilo Simvastatin Vale 20 mg/5 ml in 40 mg/5 ml ter bila indicirana za zdravljenje hiperholesterolemije in preprečevanje srčno-žilnih bolezni, je podprta z eno študijo biološke enakovrednosti, v kateri so primerjali peroralno raztopino 20 mg/5 ml z 20-mg tableto s takojšnjim sproščanjem referenčnega zdravila.
English: In conclusion, the CHMP was of the opinion that the benefit-risk ratio of Simvastatin Vale and associated names is favourable.
Slovenian: Odbor CHMP je prav tako menil, da je razmerje med koristmi in tveganji zdravila Simvastatin Vale in povezanih imen pozitivno.
English: Following potential serious risks to public health raised regarding the evidence of bioequivalence for the higher 40 mg/5 ml strength, a referral under Article 29(4) of Directive 2001/83/EC was triggered, requesting the CHMP to give its opinion on whether Simvastatin is bioequivalent to the reference product.
Slovenian: Po potencialno resnem tveganju za javno zdravje, ki se je pojavilo v zvezi z dokazom biološke enakovrednosti za večjo jakost 40 mg/5 ml, je bil v okviru člena 29(4) Direktive 2001/83/ES sprožen napotitveni postopek, ki odbor CHMP poziva, da poda svoje mnenje o tem, ali je zdravilo Simvastatin biološko enakovredno referenčnemu zdravilu.
English: Overall, having considering the totality of the available evidence, the CHMP concluded that while a deviation from the current bioequivalence guideline is acknowledged, no potential serious risk to public health was identified, that extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength is possible and that both strengths of the proposed product can therefore be considered bioequivalent to the reference product.
Slovenian: Glede na skupek razpoložljivih dokazov je odbor CHMP v splošnem zaključil, da kljub zabeleženemu odklonu od trenutnih smernic biološke enakovrednosti resnega tveganja za javno zdravje ni, da je ekstrapolacija dokazane biološke enakovrednosti z jakosti 20 mg/5 ml na jakost 40 mg/5 ml mogoča in da sta obe jakosti predlaganega zdravila zato biološko enakovredni referenčnemu zdravilu.
English: EU (MA) number Invented name
Slovenian: EU številka Izmišljeno ime
English: Packaging Package size
Slovenian: Ovojnina Velikost pakiranja
English: You will therefore need regular blood tests to determine the correct daily dose.
Slovenian: Zato boste potrebovali redne krvne preiskave za določanje pravilnega dnevnega odmerka.
English: Children and Adult
Slovenian: Otroci in odrasli
English: There is no evidence of development of tolerance.
Slovenian: Ni dokazov, da bi se razvijala toleranca.
English: However, Cystadane should not be used during pregnancy unless clearly necessary.
Slovenian: Kljub temu naj se zdravilo Cystadane med nosečnostjo ne uporablja, če ni nujno potrebno.
English: A standard battery of genotoxicity test reveals no specific hazard for humans.
Slovenian: Standardna baterija testov za genotoksičnosti ne kaže posebnega tveganja za človeka.
English: For specific recommendations, see section 4.4.
Slovenian: Za natančna priporočila glejte poglavje 4.4.
English: If you forget to take a dose take it as soon as you remember it and continue the next dose as planned.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, nato pa z naslednjim odmerkom nadaljujte tako, kot je načrtovano.
English: Your doctor will decide if you can use this medicine during pregnancy and breast-feeding.
Slovenian: Zdravnik bo odločil, ali smete med nosečnostjo in dojenjem jemati to zdravilo.
English: You should take Cystadane orally (by mouth).
Slovenian: Zdravilo Cystadane morate jemati peroralno (skozi usta).
English: Frequencies are defined as: very common (≥ 1/10), 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: Pogostnosti so definirane kot: zelo pogoste (≥ 1/10), pogoste (≥ 1/100 do < 1/10), občasne (≥ 1/1.000 do < 1/100), redke (≥ 1/10.000 do < 1/1.000), zelo redke (< 1/10.000).
English: Animal reproduction studies have not been conducted.
Slovenian: Študij razmnoževanja pri živalih niso opravili.