FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Mjerenjem koncentracije testosterona u plazmi predočen je farmakološki učinak kontinuiranog prisustva deslorelina u cirkulaciji za najmanje 6 mjeseci od aplikacije veterinarsko medicinskog proizvoda.
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.
Croatian: Tijekom aplikacije veterinarsko-medicinskog proizvoda potrebno je izbjegavati nehotično samo injiciranje tako da životinje pravilno sputamo, a igla za aplikaciju ostane zaštićena do trenutka implantacije.
English: Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Croatian: Aplicirati samo jedan implantat, neovisno o veličini psa (također vidi „Posebna upozorenja“).
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.
Croatian: Mjerenjem koncentracije testosterona u plazmi predočen je farmakološki učinak kontinuiranog prisustva desorelina u cirkulaciji za najmanje 12 mjeseci od aplikacije veterinarsko medicinskog proizvoda.
English: Do not use after the expiry date which is stated on the carton.
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na kutiji.
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.
Croatian: U jako velikih pasa (> 40 kg ), podaci su ograničeni, ali trajanje niže razine testosterona se može usporediti sa podacima dobivenim u srednjih i velikih pasa.
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.
Croatian: Kontinuirano mala doza desorelina će smanjiti funkcionalnost muških spolnih organa, libido i spermatogenezu, te smanjiti koncentraciju testoterona od 4-6 tjedana nakon implantacije.
English: Dogs and ferrets:
Croatian: Psi i afrički tvorovi:
English: The recommended dose is one implant per dog, irrespective of the size of the dog (see also point 4.4).
Croatian: Preporučena doza je jedan implantat po psu, bez obzira na veličinu (vidi dio 4.4).
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.
Croatian: Tijekom kliničkih ispitivanja sa Superlorinom 4.7 mg srednje vrijeme supresije testosterona bilo je 1,5 puta dulje u manjih pasa (<10 kg) u usporedbi sa većim psima.
English: If the hair is long, a small area should be clipped, if required.
Croatian: Ako je dlaka duža, trebalo bi ošišati mjesto implantacije.
English: MANUFACTURER'S BATCH NUMBER Batch
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: In certain cases, the implant may be lost from a treated dog.
Croatian: U određenim slučajevima može kod tretiranih pasa doći do gubitka implantata.
English: In very rare cases the temporary infertility may last more than 18 months.
Croatian: Privremena neplodnost može vrlo rijetko trajati duže od 18 mjeseci.
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.
Croatian: Jedan od 75 pasa tretiranih ovim veterinarsko-medicinskim proizvodom tijekom kliničkih pokusa se unutar 6 mjeseci od implantacije ipak spario sa kujom no ovo nije rezultiralo graviditetom.
English: 95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Croatian: 95% pasa vratilo je normalne vrijednosti testosterona u 2,5 godine od implantacije.
English: However, it is not necessary to keep bitches away from treated dogs following subsequent implantations, provided that the veterinary medicinal product is administered every 6 months.
Croatian: Kuje ipak, nije potrebno držati dalje od tretiranih pasa poslije ponovljenih implantacija ukoliko se one obavljaju svakih 6 mjeseci.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin acetate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Suprelorin je bijeli do blijedo žuti cilindrični implantat koji sadrži 4,7 mg desorelina (u obliku deslorelin acetata).
English: The veterinary medicinal product should be implanted subcutaneously in the loose skin on the back between the lower neck and the lumbar area.
Croatian: VMP treba implantirati subkutano u kožni nabor leđa između donjeg dijela vrata i lumbalne regije.
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).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Superlorin je bijeli do blijedo žuti cilindrični implantat koji sadrži 9,4 mg desorelina (u obliku desorelin acetata).
English: Pregnant women should not administer the veterinary medicinal product.
Croatian: Trudnice ne smiju primjenjivati proizvod.
English: It is therefore recommended that dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Croatian: Zbog toga se preporučuje da se psima dozvoli ulazak u pubertet prije nego im bude ugrađen implantat.
English: It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Croatian: Dokazano je da je koncentracija desorelina u plazmi najviša od 7 do 35 dana od aplikacije implantata koji je sadržavao 5 mg radioaktivnog deslorelina.
English: Infertility is achieved from 8 weeks up to at least 12 months after initial treatment.
Croatian: Neplodnost se postiže od 8 tjedana pa sve do najmanje 12 mjeseci nakon početnoga tretmana.
English: In very rare cases, there has been transitory increased sexual interest, increased testicle size and testicular pain immediately after implantation.
Croatian: U veoma rijetkom broju slučajeva postojao je pojačani seksualni interes, povećan obujam testisa i bol u testisima neposredno po implantaciji.
English: The recommended dose is one implant per dog, irrespective of the size of the dog (see also “Special warnings”).
Croatian: Preporučena doza je jedan implantat po psu neovisno od njegovoj veličini (također vidi „Posebna upozorenja“).
English: Should a treated dog mate with a bitch between 8 and 12 weeks after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Croatian: Ukoliko se tretirani pas spari sa kujom u periodu između 8 -12 tjedana po implantaciji, treba poduzeti adekvatne mjere za isključivanje rizika od gravidnosti.
English: Infertility is achieved from 6 weeks up to at least 6 months after initial treatment.
Croatian: Neplodnost se postiže od 6 tjedana pa najmanje do 6 mjeseci nakon početnoga tretmana.
English: Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Croatian: ATCvet kod: QH01CA93
English: During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Croatian: Tijekom kliničkih ispitivanja, većina manjih pasa ( < 10 kg) održali su nižu razinu testosterona duže od 12 mjeseci nakon implantacije.
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.
Croatian: Tijekom kliničkih ispitivanja, većina manjih pasa (< 10 kg tjelesne težine) održali su nižu razinu testosterona duže od 12 mjeseci nakon implantacije.
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.
Croatian: Neplodnost ( supresija spermatogeneze, smanjena veličina testisa, koncentracija testosterona ispod 0,1 ng/ml ) i supresija maskulinog mirisa se u laboratorijskim uvjetima postiže između 5 i 14 tjedana od početnoga tretmana.
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.
Croatian: Sposobnost pasa kojima je apliciran proizvod da stvaraju potomstvo po povratku normalne razine testosterona nije bila istraživana.
English: However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or repeated implantation, are limited.
Croatian: Ipak ograničeni su podaci koji demonstriraju potpunu reverzibilnost kliničkih efekata (reducirana veličina mošnji, smanjeni volumen ejakulata, smanjeni broj spermija i smanjeni libido) uključujući tu i plodnost nakon 12 mjeseci ili ponovnu implantaciju.
English: If lack of treatment efficacy is suspected, then the dog's implant (e.g. presence) should be checked.
Croatian: Ukoliko se posumnja u djelotvornost implantata tada bi trebalo provjeriti njegovu prisutnost.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA
English: The reversibility of effects and ability of treated hobs to produce offspring subsequently has not been investigated.
Croatian: Reverzibilnost efekata te sposobnost mužjaka da dobiju potomstvo nije bila istraživana.
English: Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Croatian: 98% pasa vratilo je normalne vrijednosti testosterona 18 mjeseci od implantacije.
English: However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 6 months, or repeated implantation, are limited.
Croatian: Ipak ograničeni su podaci koji demonstriraju potpunu reverzibilnost kliničkih efekata (reducirana veličina mošnji, smanjeni volumen ejakulata, smanjeni broj spermija i smanjeni libido) uključujući tu i plodnost nakon 6 mjeseci ili ponovnu implantaciju.
English: Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml, and suppression of musky odour) is achieved between 5 weeks and 14 weeks after initial treatment under laboratory conditions.
Croatian: Neplodnost (supresija spermatogeneze, smanjena veličina testisa, koncentracija testosterona ispod 0,1 ng/ml) i supresija maskulinog mirisa se u laboratorijskim uvjetima postiže između 5 i 14 tjedana od početnoga tretmana.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL POUCH
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: It has been shown in dogs that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Croatian: Dokazano je da je koncentracija deslorelina u plazmi najviša od 7 do 35 dana od aplikacije implantata koji je sadržavao 5 mg radioaktivnog desorelina.
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).
Croatian: U rijetkim slučajevima prijavljena je sumnja na izostanak djelotvornosti (za većinu slučajeva prijavljena je manja redukcija obima testisa i/ili su kuje već sparene).
English: The actuator is attached to the implanter using the Luer Lock connection.
Croatian: Aktivator je spojen sa implantatorom preko Luer nastavka.
English: Should a treated dog mate with a bitch between 6 weeks and 6 months after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Croatian: Ukoliko se tretirani pas spari s kujom u periodu između 6 tjedana i 6 mjeseci po implantaciji, treba poduzeti adekvatne mjere za isključivanje rizika od gravidnosti.
English: Do not use the product if the foil pouch is broken.
Croatian: Ne primjenjivati proizvod u slučaju da je vrećica od folije poderana.
English: The implant is supplied in a pre-loaded implanter.
Croatian: Implantat je spremljen u napunjenom implantatoru.
English: The use of Suprelorin in pre-pubertal dogs has not been investigated.
Croatian: Primjena Suprelorina kod pasa prije puberteta još nije ispitivana.
English: VIRBAC Danmark A/S Filial Sverige SE-171 21 Solna
Croatian: Sverige VIRBAC Danmark A/S Filial Sverige
English: Any mating that occurs more than 12 months after the administration of the veterinary medicinal product may result in pregnancy.
Croatian: Svako sparivanje do kojeg dolazi nakon više od 12 mjeseci poslije implantacije veterinarskog medicinskog proizvoda može rezultirati gravidnošću.
English: Treated dogs should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
Croatian: Stoga bi se tretirani psi trebali držati odvojeno od kuja u prvih 8 tjedana od početka tretmana.
English: Deslorelin (as deslorelin acetate)
Croatian: Deslorelin (u obliku deslorelin acetata)
English: During the treatment period, rare clinical effects have been reported: hair coat disorders (e.g. hair loss, alopecia, hair modification), urinary incontinence, down-regulation associated signs (decrease in testicle size, reduced activity).
Croatian: Tokom tretmana su zamijećeni rijetki klinički efekti: promjene na dlaci (npr. gubitak i modifikacija dlake, alopecija) urinarna inkontinencija i povezani znakovi smanjenja (smanjenje obujma testisa,
English: Treated dogs should therefore still be kept away from bitches on heat within the first 6 weeks after initial treatment.
Croatian: Stoga bi se tretirani psi trebali držati odvojeno od kuja u prvih 6 tjedana od početka tretmana.
English: EU/2/07/072/004
Croatian: EU/2/07/072/003 EU/2/07/072/004
English: However, it is not necessary to keep bitches away from treated dogs following subsequent implantations for the initial 8 week period, provided that the veterinary medicinal product is administered every 12 months.
Croatian: Kuje ipak nije potrebno držati dalje od tretiranih pasa poslije ponovljenih implantacija u početnom periodu od 8 tjedana ukoliko se VMP daje svakih
English: Do not use if the foil pouch is broken.
Croatian: Ne koristiti VMP ukoliko je vrećica od folije oštećena.
English: Tissue glue can be used to close the site of administration if required.
Croatian: U slučaju potrebe koristiti tkivno lijepilo za zatvaranje mjesta aplikacije.
English: Uncommonly, lack of expected efficacy has been reported in dogs (in the majority of reports a lack of reduction in testicle size was reported and/or a bitch was mated).
Croatian: Rijetko je prijavljena sumnja na izostanak djelotvornosti u pasa (za većinu slučajeva prijavljena je manja redukcija obima testisa i/ili su kuje već sparene).
English: Select the implant site by locating the area of the back midway between the shoulder blades.
Croatian: Odabrati mjesto implantiranja na sredini hrpta između lopatica.
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.
Croatian: Razlog za ponovnu implantaciju je povećanje veličine testisa i /ili povišena koncentracija testosterona i povratak seksualne aktivnosti.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues.
Croatian: Farmakoterapijska grupa: hormoni hipofize, hipotalamusa i analozi, gonadotropni releasing hormoni, (GnRH)
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.
Croatian: Što se tiče koncentracije testosterona kao potvrđenog indirektnog pokazatelja plodnosti, tijekom kliničkih ispitivanja više od 80% pasa kojima je apliciran jedan ili više implantata vratilo je normalne vrijednosti testosterona ( ≥0.4ng/ml ) unutar 12 mjeseci od implantacije.
English: Attach the actuator to the implanter using the Luer Lock connection.
Croatian: Učvrstiti aktivator na implantator pomoću Luer nastavka.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: Proizvođač odgovoran za puštanje proizvodne serije VIRBAC
English: Dogs: No clinical adverse reactions other than those described in section 4.6 have been observed following subcutaneous administration of up to 6 times the recommended dose.
Croatian: Psi; Klinički nisu primijećene nuspojave drugačije od onih opisanih u dijelu 4.6, ni poslije istovremenog apliciranja 6 puta veće doze.
English: The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Croatian: Neškodljivost poslije ponovljenih impalntacija Superlorina kod afričkih tvorova nije istraživana.
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: A short transient increase in plasma testosterone may be seen immediately after implantation.
Croatian: Odmah nakon implantacije moguć je kratkotrajni porast testosterona u plazmi.
English: Special warnings:
Croatian: 12. POSEBNA UPOZORENJA
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.
Croatian: Zbog nedostatnih podataka o primjeni Suprelorina kod pasa lakših od 10 kg ili težih od 40 kg, kada god su ove kategorije u pitanju veterinar prethodno mora procijeniti odnos koristi i rizika.
English: PHARMACEUTICAL FORM Implant.
Croatian: godine od implantacije.
English: Administer one implant only, irrespective of the size of the ferret.
Croatian: Afrički tvorovi: Aplicirati samo jedan implantat, neovisno o veličini afričkog tvora.
English: PACKAGE LEAFLET FOR: Suprelorin 4.7 mg implant for dogs
Croatian: Suprelorin 4,7 mg implantat za pse
English: It is recommended that the product should be administered under general anaesthesia in ferrets.
Croatian: Kod afričkih tvorova preporučena je implantacija pod općom anestezijom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One implant preloaded in one implanter
Croatian: SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA
English: With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials 68 % of dogs administered one implant, returned to fertility within 2 years of implantation.
Croatian: Što se tiče koncentracije testosterona (kao potvrđenog indirektnog pokazatelja plodnosti), tijekom kliničkih ispitivanja više od 68% pasa kojima je apliciran jedan implantat vratilo je plodnost za 2 godine od implantacije.
English: It is therefore recommended that ferrets should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Croatian: Zbog toga se preporučuje da se dozvoli ulazak u pubertet prije nego im bude ugrađen implantat.
English: Any mating that occurs more than 16 months after the administration of the product may result in pregnancy.
Croatian: Svako sparivanje do kojeg dolazi nakon više od 16 mjeseci poslije implantacije veterinarskog medicinskog proizvoda može rezultirati gravidnošću.
English: The recommended dose is one implant per ferret, irrespective of the size of the ferret.
Croatian: Preporučena doza je jedan implantat po afričkom tvoru neovisno o veličini.
English: Treated ferrets should therefore still be kept away from jills on heat within the first weeks after initial treatment.
Croatian: Tretirani mužjaci bi stoga trebali biti odvajani od ženki tijekom prvih tjedana od početnoga tretmana.
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.
Croatian: Zbog nedostatnih podataka o uporabi ovog VMP kod pasa lakših od 10 kg ili težih od 40 kg, kada god su ove kategorije u pitanju, veterinar prethodno mora procijeniti odnos koristi i rizika.
English: No clinical adverse reactions other than those described in section 4.6 have been observed following simultaneous subcutaneous administration of up to 10 times the recommended dose.
Croatian: Klinički nisu primijećene nuspojave drugačije od onih opisanih u dijelu 4.6 ni poslije istovremenog apliciranja 10 puta veće doze.
English: FR-06516 Carros Prantsusmaa
Croatian: FR-06516 Carros Francúzsko
English: Dogs (male) and ferrets (male).
Croatian: Psi (mužjaci) i afrički tvorovi (mužjaci).
English: In very rare cases, a transient behavioural change has been reported with development of aggression (see “Special warnings”).
Croatian: U veoma rijetkim slučajevima dolazilo je do privremenih promjena u ponašanju uz razvitak agresije.
English: Repeat treatment every 6 months to maintain efficacy.
Croatian: Tretman ponoviti svakih 6 mjeseci radi održavanja djelotvornosti.
English: For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
Croatian: Za indukciju privremene neplodnosti u zdravih, spolno zrelih mužjaka pasa.
English: Treated dogs should therefore still be kept away from bitches on heat within the first 6 weeks after initial treatment 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.
Croatian: Jedan od 75 pasa tretiranih ovim veterinarsko-medicinskim proizvodom tijekom kliničkih pokusa se unutar 6 mjeseci od implantacije ipak spario s kujom no ovo nije rezultiralo graviditetom.
English: Sodium acetate anhydrous 6.2 Major incompatibilities
Croatian: Natrijev acetat, bezvodni
English: Marketing authorisation holder: Virbac S.A.
Croatian: Nositelj odobrenja za stavljanje u promet VIRBAC S.A.
English: Repeat treatment every 12 months to maintain efficacy.
Croatian: Tretman ponoviti svakih 12 mjeseci radi održavanja djelotvornosti.
English: INDICATION(S) For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.
Croatian: Za indukciju privremene neplodnosti u zdravih, ne kastriranih, spolno zrelih mužjaka pasa.
English: Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration following simultaneous subcutaneous administration of up to 6 times the recommended dose.
Croatian: Histološki, radi se o blagoj lokalnoj reakciji s kroničnom upalom vezivnog tkiva i mjestimičnom inkapsulacijom te depozicijom kolagena, što se može zamijetiti 3 mjeseca nakon primjene do 6 puta veće doze.
English: HU-1055 Budapest Tel: +36703387177
Croatian: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21. HU-1055 Budapest Tel: +36703387177
English: The treated hobs may remain infertile up to four years.
Croatian: Tretirani mužjaci mogu ostati neplodni do 4 godine te bi VMP trebali koristiti uz oprez kod onih mužjaka koji su namijenjeni za reprodukciju.