FrancophonIA/ELRC3.0 huggingface dataset:
English: Specific studies to evaluate the effect of deslorelin when administered during pregnancy have not been conducted.
Slovenian: Specifičnih raziskav, s katerimi bi ocenili učinek dislorelina pri dajanju v nosečnosti, niso opravili.
English: Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
Slovenian: Ne vbrizgajte implantata v maščevje, ker bo sproščanje aktivne učinkovine v predelih z majhno vaskularizacijo morda zmanjšano.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu za uporabo v veterinarski medicini se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Slovenian: Farmakoterapevtska skupina: Hipofizni in hipotalamični hormoni ter sorodne učinkovine, gonadotropin sproščujoči hormoni (GnRH), oznaka ATC vet: QH01CA93.
English: Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
Slovenian: Do konca potisnite bat aktivatorja in hkrati počasi izvlecite iglo.
English: The reversibility of effects and ability of treated hobs to produce offspring subsequently has not been investigated.
Slovenian: Reverzibilnost učinkov in sposobnosti obravnavanih samcev, da zaplodijo potomce ni bila raziskana.
English: The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
Slovenian: Agonist GnRH deslorelin deluje tako, da zavira delovanje hipofizno-gonadne osi, če ga dajemo v majhnem, stalnem odmerku.
English: If the hair is long, a small area may be clipped, if required.
Slovenian: Če je dlaka dolga, je treba mogoče majhen predel postriči.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/07/2007
Slovenian: Datum pridobitve dovoljenja za promet: 10/07/2007 Datum zadnjega podaljšanja dovoljenja za promet: 17/05/2017
English: Dogs and ferrets:
Slovenian: Psi in beli dihurji:
English: However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian.
Slovenian: Če pa bi bilo treba prekiniti učinkovanje zdravila, lahko veterinar implantate kirurško odstrani.
English: It may be possible to palpate the implant in situ.
Slovenian: Mogoče boste lahko otipali implantat in situ.
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.
Slovenian: Kartonasta škatla, ki vsebuje bodisi dva bodisi pet implantatorjev, posamič zapakiranih v folijo in steriliziranih, skupaj s pripravo za implantacijo (aktivatorjem), ki ni sterilizirana.
English: In ferrets: Transient moderate swelling, pruritus and erythema at the implant site were commonly observed during clinical studies.
Slovenian: Pri belih dihurjih: Prehodno zmerno oteklino, srbenje in pordelost na mestu implantata so pogosto opazili med kliničnimi študijami.
English: Treatment in ferrets should be initiated at the beginning of the breeding season.
Slovenian: Pri belih dihurjih je z uporabo treba začeti na začetku paritvene sezone.
English: Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressive behaviour.
Slovenian: Kirurška ali kastracija z zadrilom lahko nepredvideno vpliva (t. j. izboljša ali poslabša) na agresivno obnašanje.
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.
Slovenian: Dva od 30 psov v kliničnih preskusih nista postala neplodna do približno 12 tednov po prvi uporabi zdravila, vendar v večini primerov te živali niso bile sposobne uspešno zaploditi zaroda.
English: Data demonstrate that treatment with the product will reduce the libido of the dog.
Slovenian: Podatki kažejo, da bo dajanje zdravila zmanjšalo libido psa.
English: The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Slovenian: Varnost po večkratni implantaciji s Suprelorinom pri belih dihurjih ni bila raziskana.
English: Only testosterone levels (i.e. an established surrogate marker of fertility) could definitely confirm a lack of efficacy of the treatment.
Slovenian: Pomanjkljivo učinkovitost postopka bi lahko z gotovostjo potrdila samo raven testosterona (t. j. določen nadomestni marker plodnosti).
English: In both of these circumstances a replacement implant should be administered.
Slovenian: V obeh primerih je treba uporabiti nadomestni implantat.
English: Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressiveness.
Slovenian: Kirurška ali kastracija z zdravilom lahko nepredvideno vpliva (t. j. izboljša ali poslabša) na agresivno obnašanje.
English: Pregnant women should not administer the veterinary medicinal product.
Slovenian: Nosečnice zdravila za uporabo v veterinarski medicini ne smejo dajati.
English: In very rare cases the temporary infertility may last more than 18 months.
Slovenian: V zelo redkih primerih lahko začasna neplodnost traja več kot 18 mesecev.
English: Polska VIRBAC Sp. z o.o.
Slovenian: VIRBAC Sp. z o.o.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton.
Slovenian: Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti
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).
Slovenian: V redkih primerih (>0,01 % do < 0,1%) je prišlo do suma pomanjkljive učinkovitosti (v večini primerov je prišlo do premajhnega zmanjšanja velikosti mod in/ali paritve psice).
English: Infertility is achieved from 6 weeks up to at least 6 months after initial treatment.
Slovenian: Neplodnost se doseže za čas od 6 tednov do najmanj 6 mesecev po začetni uporabi.
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.
Slovenian: Zato psov s sociopatskimi motnjami ali z epizodami intra-specifičnih (psa na psa) in/ali inter-specifičnih (psa na drugo vrsto) agresij ni dovoljeno kastrirati tako kirurško kot z implantatom.
English: Administer one implant only, irrespective of the size of the ferret.
Slovenian: Dajte samo en implantat, ne glede na velikost belega dihurja.
English: If lack of treatment efficacy is suspected, then the dog's implant (e.g. presence) should be checked.
Slovenian: V primeru pomanjkljive učinkovitosti postopka je treba preveriti pasji implantat (t. j. prisotnost).
English: Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Psi
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali), - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)), - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali), - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali), - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: The recommended dose is one implant per dog, irrespective of the size of the dog (see also point 4.4).
Slovenian: Priporočeni odmerek je en implantat na psa ne glede na velikost psa (glej tudi poglavje 4.4).
English: Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised.
Slovenian: Vsak napolnjen implantator je zapakiran v neprodušno zaprto vrečko iz folije in je, nato steriliziran.
English: It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Slovenian: Koncentracija deslorelina v plazmi je najvišja 7 do 35 dni po vsaditvi implantata, ki vsebuje 5 mg radioaktivno označenega deslorelina.
English: During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs (<10 kg) compared with all larger dogs.
Slovenian: Med kliničnimi preskusi s Suprelorinom 4,7 g, je bilo povprečje znižane koncentracije testosterona 1,5-krat daljše pri manjših psih (<10 kg) kot pri vseh večjih psih.
English: Dogs (male) and ferrets (male).
Slovenian: Psi (samci) in beli dihurji (samci).
English: The use of the veterinary medicinal product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore, should be subject to a risk/benefit assessment performed by the veterinarian.
Slovenian: Pri uporabi zdravila za uporabo v veterinarski medicini pri psih s telesno težo, manjšo od 10 kg ali večjo od 40 kg, je zato potrebna ocena razmerja med tveganjem in koristjo, ki jo opravi veterinar.
English: Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least 12 months following administration of the veterinary medicinal product.
Slovenian: Meritve plazemskih koncentracij testosterona so pokazale trajen farmakološki učinek stalne prisotnosti deslorelina v krvnem obtoku vsaj 12 mesecev po vsaditvi zdravila.
English: Do not use after the expiry date which is stated on the carton.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
English: Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least six months following administration of the veterinary medicinal product.
Slovenian: Meritve plazemskih koncentracij testosterona so pokazale trajen farmakološki učinek stalne prisotnosti deslorelina v krvnem obtoku vsaj šest mesecev po vsaditvi zdravila.
English: Tissue glue can be used to close the site of administration if required.
Slovenian: Priporočljivo je uporabiti lepilo za tkivo, da zaprete mesto implantacije, če je to potrebno.
English: During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Slovenian: Med kliničnimi preskusi je večina manjših psov (<10 kg) vzdrževala znižane koncentracije testosterona več kot 12 mesecev po implantaciji.
English: Infertility is achieved from 8 weeks up to at least 12 months after initial treatment.
Slovenian: Neplodnost se doseže za čas od 8 tednov do 12 mesecev po začetni uporabi.
English: In very rare cases, there has been transitory increased sexual interest, increased testicle size and testicular pain immediately after implantation.
Slovenian: V zelo redkih primerih je takoj po implantaciji prišlo do prehodnega povečanega spolnega zanimanja, povečane velikosti mod in bolečin v modih.
English: Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight should be subject to a risk/benefit assessment performed by the veterinarian.
Slovenian: Zaradi omejenih podatkov je uporaba Suprelorina pri psih, lažjih od 10 kg in težjih od 40 kg, odvisna od ocene razmerja med tveganjem in koristjo, ki jo opravi veterinar.
English: The need for subsequent implantations should be based on the increase in testis size and/or increase in plasma testosterone concentrations and return to sexual activity.
Slovenian: Potreba po naslednji implantaciji mora temeljiti na povečanju velikosti testisov in/ali povečanju plazemske koncentracije testosterona ter vrnitvi spolne aktivnosti.
English: For very large dogs (>40 kg), data are limited but duration of testosterone suppression was comparable to that seen in medium and large dogs.
Slovenian: Za zelo velike pse (>40 kg) so podatki omejeni, vendar je bilo trajanje supresije testosterona primerljivo s trajanjem, ugotovljenim pri srednjih in velikih psih.
English: 06516 Carros France
Slovenian: 06516 Carros FRANCIJA
English: In certain cases, the implant may be lost from a treated dog.
Slovenian: V nekaterih primerih lahko zdravljen pes izgubi implantat.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hydrogenated palm oil Lecithin
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: White to pale yellow cylindrical implant.
Slovenian: Implantat Bel do svetlo rumen valjast implantat.
English: The recommended dose is one implant per ferret, irrespective of the size of the ferret.
Slovenian: Priporočeni odmerek je en implantat na belega dihurja, ne glede na njegovo velikost.
English: Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml, and suppression of musky odor) is achieved between 5 weeks and 14 weeks after initial treatment under laboratory conditions.
Slovenian: Neplodnost (zavrtje spermatogeneze, zmanjšana velikost testisov, raven testosterona pod 0,1 ng/ml, in zavrtje vonja mošusa) se v laboratorijskih pogojih doseže v času od 5 do 14 tednov po začetni uporabi.
English: For very large dogs (>40 kg bodyweight), data are limited but duration of testosterone suppression was comparable to that seen in medium and large dogs.
Slovenian: Za zelo velike pse (>40 kg telesne mase) so podatki omejeni, vendar je bilo trajanje supresije testosterona primerljivo s trajanjem, ugotovljenim pri srednjih in velikih psih.
English: In very rare cases, a transient behavioural change has been reported with the development of aggression (see “Special warnings”).
Slovenian: V zelo redkih primerih je prišlo do prehodne spremembe obnašanja z razvojem agresije (glej »Posebna opozorila«).
English: The substance can be directly measured in the plasma up to approximately 2.5 months post implantation.
Slovenian: Učinkovino lahko neposredno merimo v plazmi še približno poltretji mesec po implantaciji.
English: The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the veterinary medicinal product, has not been investigated.
Slovenian: Sposobnosti psov, da zaplodijo potomstvo, potem ko se jim po uporabi zdravila za uporabo v veterinarski medicini plazemska koncentracija testosterona vrne na normalno vrednost, niso raziskovali.
English: 95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Slovenian: Pri 95 % psov so se plazemske koncentracije testosterona v 2,5 letih po implantaciji vrnile na normalne vrednosti.
English: The actuator is attached to the implanter using the Luer Lock connection.
Slovenian: Aktivator pritrdite na implantator s konektorjem z nastavkom po Luerju.
English: Overdose (symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
English: In case of accidental self-injection, seek medical advice immediately, with a view to having the implant removed.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom, da vam bo implantat odstranil.
English: The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs, libido and spermatogenesis and lower the plasma testosterone levels, from 4-6 weeks after implantation.
Slovenian: Stalen majhen odmerek deslorelina bo 4-6 tednov po implantaciji zmanjšal funkcionalnost moških reprodukcijskih organov, libido in spermatogenezo in znižal plazemsko koncentracijo testosterona.
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.
Slovenian: Čeprav stik kože z veterinarskim zdravilom ni verjeten, je treba, če do njega pride, nemudoma sprati izpostavljeni predel, ker se analogi GnRH lahko absorbirajo skozi kožo.
English: With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials more than 80 % of dogs administered one or more implants, returned to normal plasma testosterone levels (≥0.4 ng/ml) within 12 months of implantation.
Slovenian: Plazemska koncentracija testosterona (ki je uveljavljen nadomestni označevalec plodnosti) se je med kliničnimi preskusi pri več kot 80 % psov, ki so jim dali po enega ali več implantatov, v 12 mesecih po implantaciji vrnila na normalne vrednosti (≥0,4 ng/ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA
English: Data demonstrate that treatment with the veterinary medicinal product will reduce the libido of the dog.
Slovenian: Podatki kažejo, da bo dajanje zdravila za uporabo v veterinarski medicini zmanjšalo libido psa. Beli dihurji
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each implant contains Deslorelin (as deslorelin acetate) 4.7 mg
Slovenian: Vsak implantant vsebuje deslorelin (v obliki deslorelinijevega acetata) 4,7 mg
English: One out of 75 dogs treated with the veterinary medicinal product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Slovenian: Eden od 75 psov, ki so prejeli zdravilo za uporabo v veterinarski medicini v kliničnih preskusih, se je v šestih mesecih po implantaciji uspešno sparil s psico, ki se je gonila, vendar temu ni sledila brejost.
English: Manufacturers responsible for the batch release: Virbac S.A.
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Virbac S.A.
English: Do not use the veterinary medicinal product if the foil pouch is broken.
Slovenian: Ne uporabite zdravila za uporabo v veterinarski medicini, če je vrečka iz folije odprta ali poškodovana.
English: The veterinary medicinal product should be implanted subcutaneously in the loose skin on the back between the lower neck and the lumbar area.
Slovenian: Zdravilo za uporabo v veterinarski medicini implantirajte subkutano v ohlapno kožo na hrbtu med spodnjim delom vratu in ledvenim predelom.
English: Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Slovenian: Pri 98 odstotkih psov so se plazemske koncentracije testosterona v 18 mesecih po implantaciji vrnile na normalne vrednosti.
English: During clinical trials, most of the smaller size dogs (<10 kg bodyweight) maintained suppressed levels of testosterone for more than 12 months following implantation.
Slovenian: Med kliničnimi preskusi so se pri večini manjših psov (<10 kg telesne mase) vzdrževale znižane koncentracije testosterona več kot 12 mesecev po implantaciji.
English: It is recommended that the product should be administered under general anaesthesia in ferrets.
Slovenian: Pri belih dihurjih je priporočljivo, da implantat vsadite pod splošno anestezijo.
English: In certain cases, the implant may be lost from a treated ferret.
Slovenian: V nekaterih primerih lahko zdravljen dihur implantat izgubi.
English: The implant is supplied in a pre-loaded implanter.
Slovenian: Implantat je na voljo v napolnjenem implantatorju.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician, with a view to having the implant removed.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino, da vam bo implantat odstranil.
English: Select the implant site by locating the area of the back midway between the shoulder blades.
Slovenian: Izberite mesto implantacije v predelu hrbta sredi med lopaticama.
English: The use of Suprelorin in pre-pubertal dogs has not been investigated.
Slovenian: Uporabe Suprelorina pri psih pred puberteto niso raziskali.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sproščanje serije
English: See also “Special warnings”.
Slovenian: Glej tudi »Posebno(a) opozorilo(a)«.
English: The implant should be administered subcutaneously between the shoulder blades of the dog or ferret.
Slovenian: Implantat je treba subkutano aplicirati med lopatici psa ali belega dihurja.
English: In very rare cases there has been transitory increased sexual interest, increased testicle size and testicular pain immediately after implantation.
Slovenian: V zelo redkih primerih je prišlo takoj po implantaciji do prehodnega povečanega spolnega zanimanja, povečane velikosti mod in bolečin v modih.
English: Remove Luer Lock cap from the implanter.
Slovenian: Odstranite pokrovček z nastavkom po Luerju z implantatorja.
English: EU/2/07/072/004
Slovenian: EU/2/07/072/003 EU/2/07/072/004
English: PHARMACEUTICAL FORM Implant
Slovenian: FARMACEVTSKA OBLIKA
English: In rare cases, 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).
Slovenian: Občasno je bilo pri psih zaznano pomanjkanje pričakovane učinkovitosti (v večini primerov je prišlo do premajhnega zmanjšanja velikosti mod in/ali paritve psice).
English: In very rare cases, a transient behavioural change has been reported with the development of aggression (see section 4.4).
Slovenian: V zelo redkih primerih je prišlo do prehodne spremembe obnašanja z razvojem agresije (glej poglavje
English: When administering the veterinary medicinal product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation.
Slovenian: Pri dajanju zdravila za uporabo v veterinarski medicini pazite, da bodo živali primerno imobilizirane in da bo igla za dajanje zdravila zaščitena s pokrovčkom vse do trenutka implantacije, da si zdravila ne bi nehote samoinjicirali.
English: Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Slovenian: Dajajte samo po en implantat, ne glede na velikost psa (glej tudi »Posebna opozorila«).
English: Ferrets: There is no information available in ferrets concerning overdose.
Slovenian: Beli dihurji: Informacije za bele dihurje niso na voljo.
English: PACKAGE LEAFLET FOR: Suprelorin 4.7 mg implant for dogs
Slovenian: NAVODILO ZA UPORABO: Suprelorin 4,7 mg implantat za pse
English: Any mating that occurs more than 12 months after the administration of the veterinary medicinal product may result in pregnancy.
Slovenian: Vsako parjenje, do katerega pride več kot 12 mesecev po uporabi zdravila za uporabo v veterinarski medicini, lahko povzroči brejost.
English: In very rare cases, a testicle may be able to ascend the inguinal ring.
Slovenian: V zelo redkih primerih se lahko modo dvigne skozi dimeljski obroček.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 9.4 mg deslorelin (as deslorelin acetate).
Slovenian: Suprelorin je bel do svetlo rumen valjast implantat, ki vsebuje 9,4 mg deslorelina (v obliki deslorelinijevega acetata).