FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Danish: Farmakoterapeutisk gruppe: Hypofyse og hypothalamus hormoner og analoger, Gonadotrophinfrigørende hormoner (GnRH), ATCvet-kode: QH01CA93.
English: Administer one implant only, irrespective of the size of the ferret.
Danish: Indgiv kun ét implantat, uanset ilderens størrelse.
English: The implant is supplied in a pre-loaded implanter.
Danish: Implantatet leveres i en på forhånd fyldt implantator.
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.
Danish: Hvis en behandlet hund parrer sig med en tæve mellem 8 og 12 uger efter behandling, bør der tages passende forholdsregler for at udelukke risikoen for drægtighed..
English: Do not use the veterinary medicinal product if the foil pouch is broken.
Danish: Anvend ikke veterinærlægemidlet, hvis folieposen er i stykker.
English: In very rare cases, there has been transitory increased sexual interest, increased testicle size and testicular pain immediately after implantation.
Danish: I meget sjældne tilfælde har der været forbigående øget seksuel interesse, øget testikelstørrelse og testikelsmerter umiddelbart efter implantation.
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.
Danish: Når man indgiver veterinærlægemidlet, skal man være forsigtig for at undgå selvinjektion, ved at sikre sig, at dyrene er passende fastholdt, og at applikationskanylen er skærmet indtil implantationsøjeblikket.
English: Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Danish: Indgiv kun ét implantat, uanset hundens størrelse (se også ”Særlige advarsler”).
English: The recommended dose is one implant per dog, irrespective of the size of the dog (see also point 4.4).
Danish: Den anbefalede dosis er ét implantat pr. hund, uden hensyn til hundens størrelse (se også afsnit 4.4).
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.
Danish: Den kontinuerlige lave dosis deslorelin vil reducere funktionen af de hanlige kønsorganer, libido og spermatogenese og sænke plasmatestosteronniveauet fra 4-6 uger efter implantationen.
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.
Danish: Hvis der skulle forekomme hudkontakt med dette veterinærlægemiddel, selv om dette er usandsynligt, vaskes det eksponerede område straks, da GnRH-analoger kan absorberes gennem huden.
English: ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: INDGIVELSESVEJ(E) Subkutan anvendelse.
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).
Danish: I sjældne tilfælde (>0,01 % til < 0,1%) er der rapporteret mistanke om manglende forventet effekt (i de fleste af tilfældene er der rapporteret om manglende reduktion af testikelstørrelse og/eller parring med en tæve har fundet sted).
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.
Danish: Det er blevet vist hos hunde, at niveauet af plasmadeslorelin topper 7 til 35 dage efter indgift af et implantat indeholdende 5 mg radioaktivt mærket deslorelin.
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.
Danish: Data for meget store hundes vedkommende (>40 kg legemsvægt) er begrænsede, men varigheden af testosteronsuppressionen var sammenlignelig med den, der blev set hos middelstore og store hunde.
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.
Danish: På grund af begrænset mængde data, bør anvendelsen af veterinærlægemidlet hos hunde under 10 kg eller over 40 kg, baseres på en risk- benefit vurdering, foretaget af en dyrlæge.
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.
Danish: Papæske indeholdende enten to eller fem implantatorer pakket enkeltvist i folie, som er blevet steriliseret, sammen med et implantationsudstyr (aktivator), som ikke er blevet steriliseret.
English: It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Danish: Det er blevet vist, at niveauet af plasmadeslorelin topper 7 til 35 dage efter indgift af et implantat indeholdende 5 mg radioaktivt mærket deslorelin.
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.
Danish: Under kliniske forsøg med Suprelorin 4,7 mg var den gennemsnitlige varighed af suppression af testosteron 1,5 gange længere hos små hunde (< 10 kg) sammenlignet med større hunde.
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.
Danish: Det er dog ikke nødvendigt at holde tæver væk fra behandlede hunde efter senere implantationer, forudsat at veterinærlægemidlet indgives hver 12. måned.
English: The veterinary medicinal product should be implanted subcutaneously in the loose skin on the back between the lower neck and the lumbar area.
Danish: Veterinærlægemidlet skal implanteres subkutant i det løse skind på ryggen mellem den nederste del af halsen og det lumbale område.
English: The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Danish: Sikkerheden efter gentagne implantationer med veterinærlægemidlet hos ildere er ikke blevet undersøgt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL POUCH
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER FOLIEPOSE
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.
Danish: I kliniske forsøg opretholdt de fleste hunde af mindre størrelse (<10 kg legemsvægt) supprimerede testosteronniveauer i mere end 12 måneder efter implantation.
English: 95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Danish: 95 % af hundene vendte tilbage til normale plasmatestosteronniveauer inden for 2,5 år efter implantation.
English: Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Danish: Otteoghalvfems procent af hundene vendte tilbage til normale plasmatestosteronniveauer inden for 18 måneder efter implantation.
English: Marketing authorisation holder: Virbac S.A.
Danish: Indehaver af markedsføringstilladelsen: VIRBAC S.A.
English: The actuator is attached to the implanter using the Luer Lock connection.
Danish: Aktivatoren er sat på implantatoren ved hjælp af en forbindelse med luer-lock.
English: Manufacturers responsible for the batch release: Virbac S.A.
Danish: Fremstiller ansvarlig for batchfrigivelse: VIRBAC S.A.
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.
Danish: Derfor bør hunde med adfærdsmæssige forstyrrelser og med tilfælde af uhensigsmæssig adfærd over for andre hunde eller andre dyrearter ikke kastreres hverken kirurgisk eller med implantat.
English: It is therefore recommended that dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Danish: Det anbefales derfor, at man skal lade hunde nå puberteten, før de behandles med præparatet.
English: In certain cases, the implant may be lost from a treated dog.
Danish: I enkelte tilfælde kan en behandlet hund miste sit implantat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE
English: The recommended dose is one implant per ferret, irrespective of the size of the ferret.
Danish: Den anbefalede dosis er ét implantat pr. ilder, uden hensyn til frittens størrelse.
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.
Danish: Det er dog ikke nødvendigt at holde tæver væk fra behandlede hunde efter reimplantationer i den indledende 8 ugers periode, forudsat at veterinærlægemidlet indgives hver 12. måned.
English: One implant should be administered subcutaneously between the shoulder blades of the dog.
Danish: Et implantat skal indgives subkutant mellem hundens skulderblade.
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.
Danish: Imidlertid er de data begrænsede, der viser den fuldstændige reversibilitet af de kliniske virkninger (reduceret testikelstørrelse, reduceret ejakulationsvolumen, reduceret antal spermatozoer og reduceret libido), herunder fertilitet efter 12 måneder eller gentaget implantation.
English: Insert the entire length of the needle subcutaneously.
Danish: Indfør kanylen subkutant i hele dens længde.
English: 06516 Carros France
Danish: 06516 Carros Frankrig
English: Dogs (male).
Danish: Hunde (hanner).
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Danish: De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette veterinærlægemiddel.
English: The recommended dose is one implant per dog, irrespective of the size of the dog (see also “Special warnings”).
Danish: Den anbefalede dosis er ét implantat pr. hund, uden hensyn til hundens størrelse (se også ”Særlige advarsler”).
English: Attach the actuator to the implanter using the Luer Lock connection.
Danish: Sæt aktivatoren på implantatoren ved hjælp af luer-lock-forbindelsen.
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.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp og indlægssedlen eller etiketten bør vises til lægen med henblik på at få fjernet implantatet,.
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.
Danish: Imidlertid er de data begrænsede, der viser den fuldstændige reversibilitet af de kliniske virkninger (reduceret testikelstørrelse, reduceret ejakulationsvolumen, reduceret antal spermatozoer og reduceret libido), herunder fertilitet efter seks måneder eller gentaget.
English: Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
Danish: Tryk aktivatorstemplet helt ned og træk samtidigt kanylen tilbage.
English: Any mating that occurs more than 12 months after the administration of the veterinary medicinal product may result in pregnancy.
Danish: Enhver parring, der finder sted mere end 12 måneder efter indgift af veterinærlægemidlet, kan resultere i drægtighed.
English: Do not use if the foil pouch is broken.
Danish: Må ikke anvendes, hvis folieposen er i stykker.
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).
Danish: I behandlingsperioden har der været rapporteret om sjældne kliniske effekter; påvirkning af pels (f.eks. hårtab, alopeci, forandringer af hårstruktur), inkontinens, nedreguleringsrelaterede tegn (f.eks. reduceret testikelstørrelse, reduceret aktivitet).
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).
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Suprelorin er et hvidt til bleggult cylindrisk implantat indeholdende 9,4 mg deslorelin (som deslorelinacetat).
English: Dogs (male) and ferrets (male).
Danish: Hunde (hanner) og ildere (hanner).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each implant contains Deslorelin (as deslorelin acetate) 4.7 mg
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hvert implantat indeholder deslorelin (som deslorelinacetat) 4,7 mg
English: Do not use the product if the foil pouch is broken.
Danish: Anvend ikke præparatet, hvis folieposen er i stykker.
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.
Danish: Med hensyn til testosteronniveauer (en anerkendt surrogatmarkør for fertilitet) vendte mere end 80 % af hunde, der havde fået en eller flere implantationer, tilbage til normale plasmatestosteronniveauer (≥0,4 ng/ml) inden for 12 måneder efter implantation i kliniske forsøg.
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).
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Suprelorin er et hvidt til bleggult cylindrisk implantat indeholdende 4,7 mg deslorelin (som deslorelinacetat).
English: Treated dogs should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
Danish: Behandlede hunde skal derfor holdes væk fra tæver i løbetid inden for de første 8 uger efter den første behandling.
English: The implant should be administered subcutaneously between the shoulder blades of the dog or ferret.
Danish: Implantatet skal indgives subkutant mellem hundens eller ilderens skulderblade.
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).
Danish: I sjældne tilfælde er der rapporteret mistanke om manglende forventet effekt (i de fleste af tilfældene er der rapporteret om manglende reduktion af testikelstørrelse og/eller parring med en tæve har fundet sted).
English: In certain cases, the implant may be lost from a treated ferret.
Danish: I enkelte tilfælde kan en behandlet ilder miste sit implantat.
English: Treated dogs should therefore still be kept away from bitches on heat within the first 6 weeks after initial treatment.
Danish: Behandlede hunde skal derfor holdes væk fra tæver i løbetid inden for de første 6 uger efter den første behandling.
English: The use of the veterinary medicinal product in pre-pubertal dogs has not been investigated.
Danish: Brugen af veterinærlægemidlet til hunde før puberteten er ikke blevet undersøgt.
English: Treated ferrets should therefore still be kept away from jills on heat within the first weeks after initial treatment.
Danish: Behandlede ildere skal derfor holdes væk fra tæver i løbetid inden for de første uger efter den første behandling.
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.
Danish: Behovet for re-implantationer skal baseres på testikelstørrelse og/eller stigning plasmatestosteronniveauet og genoptagelse af seksuel aktivitet.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/072/001-002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/072/001-002
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suprelorin 4.7 mg implant for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Suprelorin 4,7 mg implantat til hunde
English: Therefore, the use of Suprelorin should be subject to a benefit/risk assessment performed by the responsible veterinarian.
Danish: Derfor bør veterinærlægemidlet først anvendes efter at dyrlægen har foretaget en vurdering af risk-benefit forholdet.
English: Moderate swelling at the implant site was observed observed for 14 days during safety/efficacy studies.
Danish: En moderat hævelse på implantationsstedet blev set i 14 dage under studierne af sikkerhed/virkning.
English: The need for subsequent implantations should be based on the increase of testis size and/or increase in plasma testosterone concentrations as well as return to sexual activity.
Danish: Behov for re-implantationer skal baseres på forøget testikelstørrelse og/eller plasmatestosteronniveau samt genoptaget seksuel aktivitet.
English: With respect to testosterone levels (i.e. an established surrogate marker of fertility), during clinical trials 68 % of dogs administered one implant, returned to fertility within 2 years of implantation.
Danish: Med hensyn til testosteronniveauer (dvs. en anerkendt surrogatmarkør for fertilitet) vendte 68 % af hunde, der fik indgivet ét implantat, i kliniske undersøgelser tilbage til fertilitet indenfor 2 år efter implantation.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/072/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/072/001
English: The use of the veterinary medicinal product in pre-pubertal ferrets has not been investigated.
Danish: Brugen af veterinærlægemidlet til ildere før puberteten er ikke blevet undersøgt.
English: In dogs: Moderate swelling at the implant site was commonly observed for 14 days during safety/efficacy studies.
Danish: Hos hunde: En moderat hævelse på implantationsstedet var almindeligt forekommende i 14 dage under studierne af sikkerhed/virkning.
English: TARGET SPECIES Dogs (male) and ferrets (male).
Danish: DYREARTER Hunde (hanner) og ildere (hanner).
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.
Danish: Hunde: Der er ikke blevet observeret andre kliniske bivirkninger end dem, der er nævnt i afsnit 4.6, efter samtidig subkutan indgift af op til 6 gange den anbefalede dosis.
English: Dogs: No adverse reactions other than those described in section “Adverse effects” have been observed following subcutaneous administration of up to 6 times the recommended dose.
Danish: Hunde: Der er ikke blevet observeret andre bivirkninger end dem, der er nævnt i ”Bivirkninger”, efter samtidig subkutan indgift af op til 6 gange den anbefalede dosis.
English: The use of Suprelorin in pre-pubertal dogs has not been investigated.
Danish: Brugen af præparatet til hunde før puberteten er ikke blevet undersøgt.
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.
Danish: Der er ikke blevet observeret andre kliniske bivirkninger end nævnt i afsnit 4.6 efter samtidig subkutan indgift af op til 10 gange den anbefalede dosis.
English: PACKAGE LEAFLET FOR: Suprelorin 4.7 mg implant for dogs
Danish: INDLÆGSSEDDEL: Suprelorin 4,7 mg implantat til hunde
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/072/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/072/003
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.
Danish: Med hensyn til testosteronniveauer (en anerkendt surrogatmarkør for fertilitet) vendte 68 % af hunde, der fik indgivet ét implantat, i kliniske undersøgelser tilbage til fertilitet indenfor 2 år efter implantation.
English: ROUTE(S) OF ADMINISTRATION Subcutaneous route
Danish: INDGIVELSESVEJ(E) Subkutan indgivelse.
English: INDICATION(S) For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.
Danish: INDIKATIONER Til fremkaldelse af midlertidig infertilitet hos raske ikke kastrerede, seksuelt modne hanhunde.
English: Any mating that occurs more than 16 months after the administration of the product may result in pregnancy.
Danish: Enhver parring, der finder sted mere end seks måneder efter indgift af præparatet, kan resultere i drægtighed.
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).
Danish: Manglende forventet effekt hos hund er ikke almindeligt forekommende (i de fleste af disse tilfælde er der rapporteret manglende reduktion af testikelstørrelse og/eller en tæve er blevet parret).
English: Repeat treatment every 16 months to maintain efficacy.
Danish: Gentag behandlingen hver 16. måned for at bevare virkningen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suprelorin 9.4 mg implant for dogs and ferrets
Danish: VETERINÆRLÆGEMIDLETS NAVN Suprelorin 9,4 mg implantat til hunde og ildere
English: PACKAGE LEAFLET FOR: Suprelorin 9.4 mg implant for dogs and ferrets
Danish: INDLÆGSSEDDEL: Suprelorin 9,4 mg implantat til hunde og ildere
English: If loss of the first implant is suspected, then this can be confirmed by observing no reduction in testis size or plasma testosterone levels as both should reduce under correct implantation.
Danish: Hvis der er mistanke om at første implantat er tabt, så kan dette verificeres ved, at der ikke observeres reduceret testikelstørrelse eller plasmatestosteronniveau, da begge burde reduceres i tilfælde af korrekt implantation.
English: TARGET SPECIES Dogs (male).
Danish: DYREARTER Hunde (hanner).
English: No clinical adverse reactions other than those described in the section “Adverse reactions” have been observed following subcutaneous administration of up to 10 times the recommended dose.
Danish: Der er ikke blevet observeret andre kliniske bivirkninger end nævnt i afsnittet ”Bivirkninger” efter samtidig subkutan indgift af op til 10 gange den anbefalede dosis.
English: Repeat treatment every 12 months to maintain efficacy.
Danish: Gentag behandlingen hver 12. måned for at bevare virkningen.
English: For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
Danish: Til fremkaldelse af midlertidig infertilitet hos raske, fuldstændig, seksuelt modne hanhunde.
English: Repeat treatment every 6 months to maintain efficacy.
Danish: Gentag behandlingen hver 6. måned for at bevare virkningen.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Deslorelin (as deslorelin acetate)
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Deslorelin (som deslorelinacetat) 4,7 mg
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One implant preloaded in one implanter
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Danish: Opbevares utilgængeligt for børn.