FrancophonIA/ELRC3.0 huggingface dataset:
English: This assessment was based on an estimated tolerable upper daily intake in humans corresponding to 0.6 mg selenium/person/day (10 µg/kg bw) and the assumption that oral bioavailability of selenium from barium selenate would be very low (although no quantitative estimate was performed).
Croatian: Ova procjena temelji se na procijenjenoj gornjoj granici podnošljivosti dnevnog unosa u ljudi od 600 µg/osobi/danu (10 µg/kg tjelesne težine) i pretpostavci da je peroralna bioraspoloživost barijeva selenata niska (iako nije provedena kvantitativna procjena).
English: The upper tolerable level for selenium intake was established in the EU by the Scientific Committee on Food (in 2000) at a lower level of 0.3 mg selenium/person/day (5 µg/kg bw) and was in 2006 confirmed by the Scientific Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority (EFSA).
Croatian: Znanstveno povjerenstvo za hranu (SCF) (2000. godine) utvrdilo je gornju granicu podnošljivosti za unos selena pri nižoj razini od 0,3 µg/osobi/danu (5 µg/kg tjelesne težine) na razini EU, te je u 2006. godini ova vrijednost potvrđena od strane Znanstvenog panela EFSA-e o dijetetskim proizvodima, prehrani i alergijama (NDA).
English: • the fact that ingestion of barium selenate injection sites will be a rare event and consequently the use of the acceptable daily intake (ADI) as the relevant health based guidance value in the
Croatian: • činjenica je da će ingestija mjesta injekcije barijeva selenata biti rijedak događaj te kao posljedica toga upitna je upotreba prihvatljivog dnevnog unosa (ADI) kao relevantne referentne vrijednosti za zdravlje u procjeni sigurne primjene u potrošača te bi prikladnija vrijednost bila izračunani LD50;
English: The risk mitigation measures used at present are not suitable to prevent consumer risk for the reasons described above.
Croatian: Zbog prethodno navedenih razloga, mjere smanjenja rizika koje se trenutno koriste nisu prikladne za sprječavanje rizika za potrošače.
English: • the CVMP considered that all residue depletion studies consistently show that, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and virtually no depletion of residues from the injection site occurs, resulting in high levels of barium selenate at injection site;
Croatian: • CVMP smatra da sva ispitivanja razgradnje rezidua dosljedno dokazuju da, nakon liječenja pri preporučenim dozama barijev selenata ostaje u mjestu injekcije tijekom dugo vremena nakon liječenja i praktički nema razgradnje rezidua u mjestu injekcije što uzrokuje visoke razine barijeva selenata u mjestu injekcije;
English: Therefore the CVMP has recommended to suspend the existing marketing authorisations of all longacting injectable veterinary medicinal products containing barium selenate until data ensuring consumer safety following use of the products are provided.
Croatian: Stoga je CVMP preporučio suspenziju postojećih odobrenja za stavljanje VMP-a u promet za sve dugodjelujuće injektabilne VMP-ove koji sadrže barijev selenat dok se ne dostave podaci koji osiguravaju sigurnost potrošača nakon primjene ovih VMP-ova.
English: When weighing the benefit for animal health in prevention and treatment of selenium deficiencies against the risk to public health via residues in food, the benefit-risk balance for long-acting injectable veterinary medicinal products containing barium selenate is considered to be negative.
Croatian: Prilikom uspoređivanja koristi za zdravlje životinja u prevenciji i liječenju deficita selena i rizika za javno zdravstvo zbog rezidua u hrani, omjer koristi i rizika za dugodjelujuće injektabilne VMP-ove koji sadrže barijev selenat smatrao se negativan.
English: Barium selenate fulfils a valuable role in the treatment and prevention of nutritional muscular dystrophy (white muscle disease), poor reproductive performance and ill thrift due to selenium deficiency.
Croatian: Barijev selenat ima vrijednu ulogu u liječenju i prevenciji nutritivne mišićne distrofije (bolest bijelih mišića), slabe reprodukcije i usporenog rasta u odnosu na unesenu hrani zbog nedostatka selena u goveda i ovaca.
English: The veterinary medicinal products concerned in the referral are given as single subcutaneous injections and contain 177.48 mg barium selenate/ml suspension for injection, equivalent to 50 mg selenium.
Croatian: Predmet ove procjene su veterinarsko-medicinski proizvodi koji se primjenjuju kao pojedinačne potkožne injekcije i sadrže suspenzije za injekciju od 177,48 mg barijeva selenata/ml što odgovara 50 mg selena.
English: Oral bioavailability of selenium from barium selenate
Croatian: Peroralna bioraspoloživost selena iz barijeva selenata
English: Following the CVMP opinion of 10 April 2013 on this referral procedure, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) requested a reexamination of that CVMP opinion.
Croatian: Limited i Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) zahtijevali su ponovnu procjenu mišljenja CVMP-a.
English: It was noted in the MRL summary report that measures should be in place to avoid consumption of injection sites.
Croatian: Međutim, u sažetku izvješća o MRL-u navedeno je da je potrebno poduzeti mjere kako bi se izbjeglo konzumiranje dijelova životinje u mjestu primijene injekcije.
English: The withdrawal period of 31 days does not guarantee depletion of residues from the injection site to safe levels as barium selenate residues remain at injection sites for long periods and if ingested, would provide orally bioavailable selenium.
Croatian: Karencija od 31 dana ne jamči razgradnju rezidua u mjestu davanja injekcije do sigurnih razina jer se rezidui barijeva selenata zadržavaju u mjestima injekcije tijekom dugih vremenskih razdoblja, te ako se ingestiraju omogućuju peroralnu bioraspoloživost selena.
English: • the CVMP considered that the benefit-risk balance for the long-acting formulations for injection containing barium selenate for all food producing species is negative as the products could pose a significant threat to human health,
Croatian: • CVMP smatra da je omjer koristi i rizika za dugodjelujuće formulacije za injekciju koje sadrže barijev selenat za životinjske vrste od kojih se proizvodi hrana negativan jer VMP-ovi mogu predstavljati značajnu prijetnju za ljudsko zdravlje.
English: Therefore, from an animal husbandry perspective it is therefore unfortunate if the long acting injectables containing barium selenate are not available.
Croatian: Stoga, iz perspektive gospodarenja životinjama nije povoljno ako dugodjelujući injektabilni VMP-ovi koji sadrže barijev selenat nisu dostupni.
English: Data has been provided to estimate the oral bioavailability of selenium following ingestion of residues of barium selenate.
Croatian: Dostavljeni su podaci za procjenu peroralne bioraspoloživosti selena nakon ingestije rezidua barijeva selenata.
English: Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from use of long-acting barium selenate containing injectable veterinary medicinal products.
Croatian: Njemačka je prijavila predmet Povjerenstvu za veterinarsko-medicinske lijekove zbog ozbiljne zabrinutosti za ljudsko zdravlje povezane s izloženošću reziduima u mjestu davanja injekcije od injektabilnih veterinarskih lijekova dugog djelovanja koji sadrže barijev selenat.
English: This implies that the colourant has the same distribution behaviour and residence time as barium selenate.
Croatian: To implicira da se boja distribuira na isti način kao i barijev selenat te da ima isto vrijeme zadržavanja.
English: For the injection site however, all residue depletion studies consistently show that following treatment at recommended doses of barium selenate there is virtually no depletion of residues, which remain at the injection site for a prolonged period of time.
Croatian: No, u mjestu injekcije, sva su ispitivanja razgradnje rezidua konstanto dokazivala da nakon tretiranja preporučenim dozama barijeva selanata doslovce nema pražnjenja rezidua, koji ostaju u mjestu injekcije tijekom produljenog razdoblja.
English: In relation to the comments that barium selenate injection sites will be trimmed off and discarded at the slaughter house, the CVMP
Croatian: U vezi s komentarima da će mjesta injekcije barijeva selenata biti izrezana i odbačena u
English: Co. Kerry
Croatian: Kerry Irska
English: the CVMP has recommended the refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations for long-acting formulations for injection containing barium selenate for all food producing species (see annex I).
Croatian: CVMP je preporučio odbijanje davanja odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet i suspenziju odobrenja za stavljanje u veterinarsko-medicinskog proizvoda promet za dugodjelujuće formulacije za injekciju koji sadrže barijev selenat za sve vrste koje se koriste u proizvodnji hrane (vidjeti Dodatak I.).
English: The condition for lifting the suspension of the marketing authorisations is described in annex III.
Croatian: Uvjet za ukidanje suspenzije odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda opisan je u Dodatku III.
English: Condition for lifting the suspension of the marketing authorisations
Croatian: Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Proc. Aust.
Croatian: Aust.
English: However, the available information indicates that the use of veterinary medicinal products containing barium selenate administered subcutaneously pose a significant threat to human health due to persistent selenium residues at the injection site.
Croatian: Međutim, dostupne informacije ukazuju da upotreba veterinarsko-medicinskih proizvoda za potkožnu primjenu koji sadrže barijev selenat predstavljaju značajnu prijetnju za ljudsko zdravlje.
English: Annex III
Croatian: Dodatak III.
English: Grounds for refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations
Croatian: Temelji za odbijanje izdavanja odobrenja za stavljanje VMP-a u promet i za suspenziju odobrenja za stavljanje lijeka u promet
English: Killarney
Croatian: Karencija
English: Applicant/Marketing Authorisation Holder
Croatian: Podnositelj zahtjeva / Nositelj odobrenja za stavljanje lijeka u promet
English: Germany
Croatian: Belgija
English: Background (MRL status)
Croatian: Osnovne informacije (status maksimalne dopuštene koncentracije rezidua)
English: Soc. Anim.
Croatian: Soc.
English: Marketing authorisation not granted
Croatian: Nije dano odobrenje za stavljanje VMP-a u promet
English: Sweden Cross Vetpharm Group Limited
Croatian: Švedska Cross Vetpharm Group Limited
English: Romania Cross Vetpharm Group Limited
Croatian: Rumunjska Cross Vetpharm Group Limited
English: Estonia Cross Vetpharm Group Limited
Croatian: Estonija Cross Vetpharm Group Limited
English: Poland Cross Vetpharm Group Limited
Croatian: Poljska Cross Vetpharm Group Limited
English: Slovakia Cross Vetpharm Group Limited
Croatian: Slovačka Cross Vetpharm Group Limited
English: France Cross Vetpharm Group Limited
Croatian: Francuska Cross Vetpharm Group Limited
English: Spain Cross Vetpharm Group Limited
Croatian: Španjolska Cross Vetpharm Group Limited
English: Denmark Cross Vetpharm Group Limited
Croatian: Danska Cross Vetpharm Group Limited
English: B.V.P.
Croatian: Prod.
English: These signs resolved without treatment.
Croatian: Ovi su znaci nestali bez liječenja.
English: The actuator can be re-used.
Croatian: Aktivator može biti ponovno upotrebljen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Croatian: Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
English: See also point 4.4.
Croatian: Također vidi dio 4.4.
English: Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
Croatian: 13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση
English: The metabolism of deslorelin is rapid.
Croatian: Metabolizam deslorelina je brz.
English: Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressive behaviour.
Croatian: Kirurška ili medicinska kastracija može imati neočekivane posljedice (tj. poboljšanje ili pogoršanje) agresivnog ponašanja.
English: In very rare cases, a testicle may be able to ascend the inguinal ring.
Croatian: U vrlo rijetkim slučajevima testis se može popeti kroz ingvinalni prsten.
English: Only testosterone levels (i.e. an established surrogate marker of fertility) could definitely confirm a lack of efficacy of the treatment.
Croatian: Jedino razina testosterona (tj. utvrđeni indirektni pokazatelj plodnosti) može definitivno potvrditi manjak djelotvornosti tretmana.
English: The biocompatible implant does not require removal.
Croatian: Biokompatibilni implantat nije potrebno uklanjati.
English: See also “Special warnings”.
Croatian: Vidi „posebna upozorenja“.
English: Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.
Croatian: Pritisnuti kožu na mjestu aplikacije nakon izvlačenja igle i držati pritisnuto 30 sekundi.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2 ºC - 8 ºC).
English: Not all pack sizes may be marketed.
Croatian: Ne moraju svi veličine pakovanja biti u prometu.
English: White to pale yellow cylindrical implant.
Croatian: Bijeli do blijedo žuti cilindrični implantat.
English: 2 implants preloaded in implanters + 1 actuator 5 implants preloaded in implanters + 1 actuator
Croatian: 2 implantata, napunjena u implantatore + 1 aktivator 5 implantata, napunjena u implantatore + 1 aktivator
English: Implants may be located using ultrasound.
Croatian: Implantat se može locirati ultrazvukom.
English: In both of these circumstances a replacement implant should be administered.
Croatian: U oba slučaja treba ugraditi zamjenski implantat.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako primijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo javite se veterinaru.
English: Dogs (male).
Croatian: Psi (mužjaci).
English: Hydrogenated palm oil Lecithin
Croatian: Hidrogenizirano palmino ulje Lecitin
English: Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin.
Croatian: Mada je malo vjerojatno da će doći do kontakta VMP-a s kožom, ukoliko se to ipak dogodi, izloženi dio treba odmah oprati pošto se GnRH analozi mogu apsorbirati kroz kožu.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI UPOTREBE
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Croatian: Rok valjanosti veterinarsko medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
English: Date of latest renewal: 17/05/2017
Croatian: Datum prvog odobrenja 10/07/2007 Datum posljednje obnove: 17/05/2017
English: Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised.
Croatian: Svaki napunjeni implantator je pakovan u zavarenu vrećicu od folije koja se naknadno sterilizira.
English: Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
Croatian: Izbjegavati implantaciju u masno tkivo jer oslobađanje djelatne tvari može biti oslabljeno u slabo prokrvljenim područjima.
English: 4.8 Interaction with other medicinal products and other forms of interaction None known.
Croatian: 4.8 Interakcije s drugim VMP i drugi oblici interakcija
English: Examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
Croatian: Pregledati brizgaljku i iglu da bi se uvjerili da u njima nije ostao implantat i da se vidi razmaknica.
English: This suppression results in the failure of treated animals to synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the hormones responsible for the maintenance of fertility.
Croatian: Ova supresija sprečava tretirane životinje da sintetiziraju i/ili otpuštaju folikulo-stimulirajući hormon (FSH) i luteinizirajući hormon (LH), oba odgovorna za održavanje plodnosti.
English: In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals were not capable of successfully siring offspring.
Croatian: U dva od 30 pasa, tijekom kliničkih pokusa, neplodnost nije postignuta približno 12 tjedana od početnoga tretmana, no u većini slučajeva životinje nisu bile sposobne za uspješno stvaranje potomstva.
English: Levels of testosterone remain below 0.1 ng/ml for at least 16 months.
Croatian: Koncentracija testosterona ostaje ispod 0,1 ng/ml kroz najmanje 16 mjeseci.
English: Not all parameters of sexual activity have been tested specifically (seborrhoea, urine marking and aggressiveness).
Croatian: Nisu svi znakovi seksualne aktivnosti posebno provjeravani; (seboreja,obilježavanje teritorija urinom i agresivnost).
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati u hladnjaku
English: However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian.
Croatian: No, ukoliko je neophodno potrebno prekinuti tretman veterinar može ukloniti implantat kirurškim putem.
English: In case of accidental self-injection, seek medical advice immediately, with a view to having the implant removed.
Croatian: U slučaju nehotičnog samo-injiciranja odmah potražiti liječničku pomoć s ciljem uklanjanja implantata.
English: Another GnRH analogue has been shown to be foetotoxic in laboratory animals.
Croatian: Za drugi analog GnRH je dokazano na laboratorijskim životinjama da je fetotoksičan.
English: For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u djelu 6.1.
English: Treatment in ferrets should be initiated at the beginning of the breeding season.
Croatian: Afričke tvorove bi trebalo tretirati na početku sezone parenja.
English: Thus, dogs with sociopathic disorders and showing episodes of intra-specific (dog to dog) and/or inter-specific (dog to another species) aggressions should not be castrated either surgically or with the implant.
Croatian: Zbog toga psi sa sociopatskim poremećajima ili oni koji pokazuju epizode interspecifične (pas-pas) i /ili intraspecifične (pas-ostale vrste) agresije ne bi trebali biti kastrirani bilo kirurškim putem ili implantatom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija
English: Therefore, the use of Suprelorin should be subject to a benefit/risk assessment performed by the responsible veterinarian.
Croatian: Stoga bi primjena Superlorina trebala biti predmet procjene odnosa koristi i rizika od strane veterinara.
English: Cardboard carton containing either two or five individually foil wrapped implanters that have been sterilised, together with an implanting device (actuator) that is not sterilised.
Croatian: Kartonska kutija sadrži ili 2 ili 5 individualno upakiranih i sterilnih implantatora zajedno sa uređajem za implantaciju ( aktivatorom ) koji nije sterilan.
English: It may be possible to palpate the implant in situ.
Croatian: Moguće je napipati implantat in situ.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA OBZIROM NA OPSKRBU I UPOTREBU
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Croatian: Farmakoterapijska grupa: hormoni hipofize, hipotalamusa i analozi, gonadotropni releasing hormoni (GnRH), ATCvet kod: QH01CA93
English: Data demonstrate that treatment with the product will reduce the libido of the dog.
Croatian: Podaci pokazuju da će tretman VMP-om reducirati libido pasa.
English: Show the package leaflet or the label to the physician.
Croatian: Liječniku pokazati uputu ili etiketu.
English: Insert the entire length of the needle subcutaneously.
Croatian: Iglu uvesti cijelom dužinom subkutano.
English: Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
Croatian: 4. Do kraja pritisnuti klip aktivatora i u isto vrijeme lagano izvući iglu.
English: The substance can be directly measured in the plasma up to approximately 2.5 months post implantation.
Croatian: Deslorelin se može direktno izmjeriti u plazmi do približno 2,5 mjeseca od implantacije.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton.
Croatian: Ne koristiti ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji
English: In rare cases (>0.01 % to < 0.1%), suspected lack of expected efficacy has been reported (in the majority of cases a lack of reduction of testicle size was reported and/or a bitch was mated).
Croatian: U rijetkim slučajevima (>0,01% do <0,1% ) prijavljena je sumnja na izostanak djelotvornosti (za većinu slučajeva prijavljena je manja redukcija obima testisa i/ili su kuje već sparene).
English: Lift the loose skin between the shoulder blades.
Croatian: Podići kožni nabor između lopatica.
English: In very rare cases, a transient behavioural change has been reported with the development of aggression (see section 4.4).
Croatian: Još rjeđe prijavljene su i promjene u ponašanju uz razvitak agresije (vidi dio 4.4).
English: Remove Luer Lock cap from the implanter.
Croatian: Ukloniti Luer zatvarač s implantatora.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan dosega i pogleda djece.
English: In very rare cases (< 0.01 %) the temporary infertility may last more than 18 months.
Croatian: Privremena neplodnost može vrlo rijetko (< 0,01 %) trajati duže od 18 mjeseci.
English: The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
Croatian: Kao GnRH agonist, desorelin djeluje tako da prekida vezu između hipofize i spolnih žlijezda kada se aplicira u manjim kontinuiranim dozama.
English: Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction of infection.
Croatian: Prije zahvata treba dezinficirati kožu na mjestu implantacije da bi se izbjegla infekcija.
English: Specific studies to evaluate the effect of deslorelin when administered during pregnancy have not been conducted.
Croatian: Specifična ispitivanja procjene učinka deslorelina u slučajevima aplikacije tijekom trudnoće nisu bile provedena.