qanastek/EMEA-V3 huggingface dataset:
Three tubes each containing 1.0 ml (120 mg selamectin).
Tliet tubi li fihom 1. 0 ml (120 mg selamektin) kull wieħed.
Six tubes each containing 1.0 ml (120 mg selamectin).
Sitt tubi li fihom 1. 0 ml (120 mg selamektin) kull wieħed.
Dogs weighing 10.1 – 20.0 kg.
Klieb li jiżnu bejn 10. 1 kg u 20 kg.
EU/ 2/ 99/ 014/ 005 (3 tubes) EU/ 2/ 99/ 014/ 010 (6 tubes)
EU/ 2/ 99/ 014/ 005 (3 tubi) EU/ 2/ 99/ 014/ 010 (6 tubi)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON LABEL, 240 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 240 mg (DAQSIJIET KOLLHA)
Selamectin 240 mg
Selamektin 240 mg
Three tubes each containing 2.0 ml (240 mg selamectin).
Tliet tubi li fihom 2. 0 ml (240 mg selamektin) kull wieħed.
Six tubes each containing 2.0 ml (240 mg selamectin).
Sitt tubi li fihom 2. 0 ml (240 mg selamektin) kull wieħed.
Dogs weighing 20.1 – 40.0 kg.
Klieb li jiżnu bejn 20. 1 kg u 40 kg.
EU/ 2/ 99/ 014/ 006 (3 tubes) EU/ 2/ 99/ 014/ 011 (6 tubes)
EU/ 2/ 99/ 014/ 006 (3 tubi) EU/ 2/ 99/ 014/ 011 (6 tubi)
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 15 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 15 mg (DAQSIJIET KOLLHA)
15 mg selamectin
15 mg selamektin
Topical spot-on solution
Soluzzjoni għal użu topikali
BATCH NUMBER
ŻMIEN TA ’ TIŻMIM
{number}
Ma jgħoddx
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 30 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 30 mg (DAQSIJIET KOLLHA)
30 mg selamectin
30 mg selamektin
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 45 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 45 mg (DAQSIJIET KOLLHA)
45 mg selamectin
45 mg selamektin
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 60 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 60 mg (DAQSIJIET KOLLHA)
60 mg selamectin
60 mg selamektin
35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 120 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 120 mg (DAQSIJIET KOLLHA)
120 mg selamectin
120 mg selamektin
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
FOIL LABEL, 240 mg (ALL PACK SIZES)
TIKKETTA FUQ IL- FOLJA, 240 mg (DAQSIJIET KOLLHA)
For animal treatment only.
FULJETT TA 'TAGĦRIF FIL- PAKKETT
PACKAGE LEAFLET
37 FULJETT TA ’ TAGĦRIF FIL- PAKKETT STRONGHOLD Soluzzjoni għal użu topikali
Manufacturer responsible for batch release:
Manifattur li jħalli l- konsenja tmur fis- suq:
Each unit dose (tube) of STRONGHOLD delivers
Kull doża waħda (tubu) ta ’ STRONGHOLD tagħti:
Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration.
Kura u prevenzjoni minn infestazzjonijiet tal- briegħed ikkawżat mill- ispeċi Ctenocephalides sa xahar wara li tingħata doża waħda.
This is as a result of the adulticidal, larvicidal and ovicidal properties of the product.
Dan jiġri billi l- prodott joqtol kemm il- bergħud kif ukoll il - larva u l- bajd tiegħu.
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age.
Bi tnaqqis fil - popolazzjoni tal- briegħed, trattament kull xahar ta ’ annimali tqal u li qed irreddgħu jgħin ukoll biex ihħares il- btan sa seba ’ ġimgħat minn infestazzjonijiet tal- briegħed.
The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Il- prodott jista ’ jintuża bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall- briegħed u billi joqtol il - bajd u l- larva jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal..
Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Prevenzjoni mill- marda tal- heartworm ikkawżata mid- Dirofilaria immitis b’ amministrazzjoni kull xahar.
STRONGHOLD may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with STRONGHOLD.
STRONGHOLD jista ’ jintuża bla periklu fuq annimali infettati bill- forma adulta tal - heartworm, imma prattika tajba veterinarja titlob li l- annimali kollha ta ’ ‘ l fuq minn sitt xhur u li jgħixu f’ pajjiżi fejn jeżistu parassiti li jġorru il- marda, għandhom jiġu ttestjati għall- infezzjoni bil - forma adulta tal- heartworm qabel ma tinbeda l- kura bi STRONGHOLD.
Treatment of ear mites (Otodectes cynotis).
Kura għad- dud tal- widnejn (Otodectes cynotis).
Treatment of biting lice infestations (Felicola subrostratus) Treatment of adult roundworms (Toxocara cati) Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Kura għal infestazzjonijiet ta ’ qamel li jigdem (Felicola subrostratus) Kura għall- forma adulta tal- ħniex tondi tal- imsaren (Toxocara cati) Kura għall- forma adulta tal- hookworms fl- imsaren (Ancylostoma tubaeforme).
Treatment of adult intestinal roundworms (Toxocara canis)
Kura għal infestazzjonijiet ta ’ qamel li jigdem (Trichodectes canis) Kura għal sarcoptic mange (ikkawżata minn Sarcoptes scabiei) Kura għall- forma adulta tal- ħniex tondi fl- imsaren (Toxocara canis).
This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the product.
Din hija ħaġa normali u titlaq fi żmien 24 siegħa minn meta jiġi applikat u ma taffettwax in- nuqqas ta ’ periklu jew l- effett tal- prodott.
40 It is important to apply the dose as indicated to minimise the quantity that the animal can lick off.
39 Huwa mportanti li tingħata d- doża kif indikat biex jitnaqqas l- ammont li l- annimal jista ’ jilgħaq.
If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Jekk l- annimal jilgħaq fit- tul, f’ każi rari jista ’ jkun hemm produzzjoni għolja ta ’ bżieq fil- qtates għal perjodu qasir.
Other information
Informazzjoni oħra
STRONGHOLD has been tested with no other adverse reactions in over 100 different pure and mixed breeds of dogs including collies, and in mixed breeds and 16 pure breeds of cats.
STRONGHOLD ġie ittestjat f’ aktar minn mitt razza pura u mħallta ta ’ klieb li jinkludu l- collie, u f’ razez mħallta u sittax- il razza pura ta ’ qtates mingħajr effetti oħra mhux mixtieqa.
The product was administered at 10 times the recommended dose, and no undesirable effects were observed.
Il- prodott ingħata f’ doża li kienet għaxar darbiet aktar minn dik irrakkomandata, u ma dehrux effetti mhux mixtieqa.
The product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Il- prodott ingħata f’ doża tlett darbiet aktar minn dik irrakkomandata fi qtates u klieb li kellhom heartworms adulti u ma dehrux effetti mhux mixtieqa.
The product was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive collies, and no undesirable effects were observed.
Il- prodott ingħata wkoll f’ doża tlett darbiet aktar minn dik irrakkomandata fi qtates u klieb irġiel u nisa waqt it- tnissil kif ukoll f’ nisa tqal u waqt li qed ireddgħu il- btan tagħhom, u f’ doża ħames darbiet aktar minn dik irrakkomandata fi klieb tar- razza collie sensittivi għall- ivermektin u ma dehrux effetti mhux mixtieqa.
In extensive field testing no interactions between the product and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Fi studji estensivi waqt l- użu ma kienux osservati effetti bejn STRONGHOLD u prodotti mediċinali veterinarji komuni jew proċeduri mediċi u kirurġiċi.
If you notice any other side effects, please inform your veterinary surgeon.
Jekk tinnota xi effetti oħra mhux mixtieqa, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
STRONGHOLD 15 mg: cats and dogs weighing 2.5 kg or less STRONGHOLD 30 mg: dogs weighing 2.6 kg - 5.0 kg STRONGHOLD 45 mg: cats weighing 2.6 kg - 7.5 kg STRONGHOLD 60 mg: dogs weighing 5.1 kg - 10.0 kg STRONGHOLD 120 mg: dogs weighing 10.1 kg - 20.0 kg STRONGHOLD 240 mg: dogs weighing 20.1 kg - 40.0kg
STRONGHOLD 15 mg: qtates u klieb li jiżnu 2. 5 kg jew anqas STRONGHOLD 30 mg: klieb li jiżnu bejn 2. 6 kg u 5. 0 kg STRONGHOLD 45 mg: qtates li jiżnu bejn 2. 6 kg u 7. 5 kg STRONGHOLD 60 mg: klieb li jiżnu bejn 5. 1 kg u 10. 0 kg STRONGHOLD 120 mg: klieb li jiżnu bejn 10. 1 kg u 20. 0 kg STRONGHOLD 240 mg: klieb li jiżnu bejn 20. 1 kg u 40. 0kg
Administer STRONGHOLD topically in accordance with the following table:
Applika STRONGHOLD topikalment skond kif indikat fit- tabella li tmiss:
Dogs (kg)
Klieb (kg)
41 Flea treatment and prevention (cats and dogs)
40 Kura u prevenzjoni mill- briegħed (qtates u klieb)
Animals older than six weeks of age:
• Annimali ta ’ ‘ l fuq minn sitt ġimgħat:
Following administration of the product to the animal, adult fleas and larvae are killed and no viable eggs are produced.
Wara li jingħata il- prodott lill- annimal, il- briegħad adulti u l- larvi jinqatlu u ma jkunx hemm aktar bajd vijabbli.
This stops flea reproduction and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Dan iżomm il- briegħed milli jirriproduċu jista ’ jgħin biex jikkontrolla infestazzjonijiet tal - briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal.
For the prevention of flea infestations, the product should be administered to the animal at monthly intervals throughout the flea season, starting one month before fleas become active.
Għal prevenzjoni minn infestazzjonijiet tal- briegħed, il- prodott għandu jingħata lill- annimal kull xahar waqt l- istaġun tal- briegħed u xahar qabel ma l- briegħed isiru attivi.
This ensures that fleas infesting the animal are killed, no viable flea eggs are produced by these fleas, and larvae (found only in the environment) are also killed.
Dan jiżgura li l- briegħed fuq l - annimal jinqatlu, dawn ma jipproduċux bajd vijabbli u l- larvi (li jinsabu biss fl- ambjent) jinqatlu wkoll..
This breaks the flea life cycle and prevents flea infestations.
B’ hekk jinkiser iċ- ċiklu tal- ħajja tal- bergħud u ma jħallix infestazzjonijiet mill- briegħed.
For use as part of a treatment strategy for flea allergy dermatitis the product should be administered at monthly intervals.
Għal użu bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall- briegħed, il - prodott għandu jingħata kull xahar.
Treatment of pregnant and lactating animals to prevent flea infestations in puppies and kittens:
Kura ta ’ annimali tqal u li qed ireddgħu biex jitħarsu il- ġriewi u l- friegħ minn infestazzjonijiet tal- briegħed:
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age.
Billi l- popolazzjoni ta ’ briegħed titnaqqas, il- kura ta ’ kull xahar f’ annimali tqal jew li qed ireddgħu, tgħin biex tħares ‘ il boton minn infestazzjonijiet tal- briegħed sa l- eta ’ ta ’ seba ’ ġimgħat.
When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the product must be given within a month of the last dose of the former medication.
Meta jkun qed jiġi mibdul prodott għall- prevenzjoni tal- heartworm f’ programm ta ’ prevenzjoni mill- mard tal- heartworm, l- ewwel doża tal- prodott għanda tingħata fi żmien xahar mill- aħħar doża tal - mediċina ta ’ qabel.
Treatment of roundworm infections (cats and dogs)
Kura għal infezzjonijiet tal- ħniex tondi tal- imsaren (qtates u klieb)
Treatment of ear mites (dogs)
Kura għad- dud tal- widnejn (klieb)
42 Treatment of sarcoptic mange (dogs)
41 Kura għal sarcoptic mange (klieb)
The appropriate length of the treatment period for individual parasites is specified in section DOSAGE FOR EACH SPECIES.
It- tul xieraq tal- perjodu ta ’ kura għal kull parassita jidher fis- sezzjoni DOŻA GHAL KULL SPEĊI.
Do not apply when the hair coat is wet.
Tapplikax meta l- pil ta ’ l- annimal ikun imxarrab.
However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
Iżda jekk taħsel b’ xampu jew tgħoddos l- annimal sagħtejn jew aktar wara l- kura, l- effett ma jkunx imnaqqas.
Store in the unopened foil package in a dry place.
Aħżen fil- pakkett tal- folja mhux miftuħ f’ post xott.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ skadenza mniżżla fuq it- tikketta.
Do not allow treated animals to bathe in water courses until at least two hours after treatment.
Tħallix annimali kkurati jidħlu f’ ilma ġieri ta ’ l- anqas sa sagħtejn minn meta tingħata l- kura.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Prodott li ma ntużax jew materjal żejjed għandhom jintremew skond kif jitolbu l- ħtiġijiet lokali.
STRONGHOLD is available in packs of three tubes (for all tube sizes), six tubes (for all tube sizes except 15 mg selamectin), or fifteen tubes (for 15 mg selamectin tube size only).
STRONGHOLD jiġi f’ pakketti ta ’ tlett tubi (tubi tad- daqsijiet kollha), ta ’ sitt tubi (tubi tad- daqsijiet kollha ħlief 15 mg selamektin), jew ta ’ ħmistax- il tubu (tubi ta ’ 15 mg selamektin biss).
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant topikali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropea.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, waslet għar - rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
What is Suprelorin?
X’ inhu Suprelorin?
Suprelorin is an implant containing the active substance deslorelin.
Suprelorin huwa impjant li fih is- sustanza attiva deslorelin.
It is presented in a pre-loaded applicator.
Jiġi f’ applikatur mimli għal- lest.
What is Suprelorin used for?
Għal x’ hiex jintuża Suprelorin?
Suprelorin is used for male dogs to make them temporarily infertile.
Suprelorin jintuża għal klieb irġiel sabiex jagħmilhom temporanjament infertili.
It is used in healthy, sexually- mature dogs that have not been neutered.
Jintuża fi klieb b’ saħħithom, sesswalment maturi li ma jkunux ikkastrati.
The implant is inserted subcutaneously, under the loose skin on the back between the lower neck and the lumbar area.
L- impjant jiddaħħal taħt il- ġilda, eżattament taħt il- ġilda laxka tad- dahar bejn il- parti t’ isfel ta ’ l- għonq u l- parti tal- ġenbejn.
Suprelorin starts being effective after about six weeks, and the effect continues for six months, after which the dog can be re-implanted if necessary.
Superlorin jibda jaħdem wara sitt ġimgħat u l- effett jibqa ’ għal sitt xhur, wara liema, il- kelb jista ’ jiġi impjantat mill - ġdid jekk ikun hemm bżonn.
Effectiveness is immediate if re-implanted approximately 6 months following previous implantation.
L- effettività hija immedjata jekk l- impjantazzjoni mill- ġdid issir wara madwar 6 xhur wara l- impjantazzjoni preċedenti.
How does Suprelorin work?
Kif jaħdem Suprelorin?
The active substance in Suprelorin, deslorelin, acts like the natural hormone gonadotropin-releasing hormone (GnRH) which controls the secretion of other hormones involved in fertility.
Is- sustanza attiva f’ Suprelorin, deslorelin, taġixxi bħall- ormon naturali, gonadotropin- releasin hormone (GnRH) li jikkontrolla s- sekrezzjoni ta ’ ormoni oħra involuti fil- fertilità.
Suprelorin is given as an implant that slowly releases a continuous low dose of deslorelin.
Suprelorin jingħata bħala impjant li bil- mod il- mod jirrilaxxa doża baxxa kontinwa ta ’ deslorelin.
This suppresses (blocks) the production of follicle stimulating hormone (FSH) and luteinising hormone (LH).
Dan irażżan (jimblokka) l- produzzjoni tal- follicle stimulating hormone (FSH) u luteinising hormone (LH).
As a result in male dogs, less testosterone circulates in the blood, the dog stops producing sperm and its libido is reduced.
B’ konsegwenza t’ hekk, fi klieb irġiel, jiċċirkola inqas testosterone fid- demm, il- kelb jieqaf jipproduċi sperma u l - ġibdiet sesswali tiegħu jonqsu.
If a dog under treatment with Suprelorin were to mate with a bitch on heat, the chance of the bitch becoming pregnant would be extremely low.
Li kieku kelb li jkun qiegħed jiġi ttrattat bi Suprelorin kellu jitgħammar ma ’ kelba sħuna, iċ- ċans li l- kelba tinqabad tqila jkun baxx ferm.
How has Suprelorin been studied?
Kif ġie studjat Suprelorin?
Suprelorin has been studied under field conditions in dogs weighing between 10 and 25 kg which were implanted before being followed up for up to a year.
Suprelorin ġie studjat taħt kundizzjonijiet bażi fuq klieb li jiżnu bejn 10 u 25 kg li ġew impjantati qabel ma ġew segwiti għal madwar sena.
The studies looked at the effect of Suprelorin on blood testosterone levels, the size of the testicles and the ability of the dogs to produce semen for collection.
L- istudji studjaw l- effett ta ’ Suprelorin fuq il- livelli ta ’ testosterone fid- demm, id- daqs tat- testikoli u l- abilità tal- klieb li jipproduċu semen għall- ġbir.
In some of these studies, the dogs received Suprelorin more than once and were observed for up to a year after receiving the final implant.
F’ xi wħud minn dawn l- istudji, il- klieb irċevew Suprelorin aktar minn darba u ġew osservati għal madwar sena wara li rċevew l- impjant finali.
The safety of Suprelorin was studied after giving dogs more than 10 times the recommended dose rate.
Is- sigurtà ta ’ Suprelorin ġiet studjata wara li l- klieb ingħataw aktar minn 10 darbiet ir- rata tad- doża rakkomandata.
What benefit has Suprelorin shown during the studies?
X’ benefiċċju wera Suprelorin matul dawn l- istudji?
All studies showed a reduction of testosterone levels in the blood, a reduction in the size of the testicles, decreased libido and decreased spermatogenesis (when fewer sperms are produced by the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
F’ aktar 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In more than 95% of dogs, these effects started at six weeks after implantation and lasted for at least six months.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged minn 95% tal- klieb, dawn l- effetti bdew sitt ġimgħat wara l- impjantazzjoni u damu għal mill- inqas sitt xhur.
The majority of dogs regained normal semen characteristics approximately one year after the last treatment and dogs have been able to successfully mate with bitches, after treatment with Suprelorin was stopped.
Il- maġġoranza tal- klieb reġgħu kisbu lura l- karatteristiċi normali tas- semen madwar sena wara l - aħħar trattament u l- klieb setgħu jitgħammru b’ suċċess ma ’ klieb nisa, wara li t- trattament b’ Suprelorin twaqqaf.
What is the risk associated with Suprelorin?
X’ inhu r- riskju assoċjat ma ’ Suprelorin?
Dogs can have some moderate swelling at the implant site in the two weeks after implantation.
Il- klieb jista ’ jkollhom nefħiet moderati fis- sit ta ’ l- impjantazzjoni fil- ġimagħtejn wara l - impjantazzjoni.
There can also some be some local reaction (e. g. inflammation, hardening) for up to three months after implantation.
Jista ’ jkun hemm ukoll xi reazzjoni lokali (eż. infjammazzjoni, twebbis) għal mhux aktar minn tliet xhur wara l- impjantazzjoni.
Any swelling or local reaction resolves naturally.
Kull nefħa jew reazzjoni fil- post tgħaddi b’ mod naturali.
The size of the testicles will decrease during treatment.
Id- daqs tat- testikoli jonqos matul it- trattament.
Suprelorin is not recommended for use in dogs that have not yet reached puberty, as it has not been investigated in these animals.
Suprelorin m’ huwiex rakkomandat sabiex jintuża fuq klieb li għadhom ma laħqux il- pubertà, minħabba li ma ġiex investigat f’ dawn l- annimali.
For a full list of all side effects reported with Suprelorin, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrapportati b ’ Suprelorin, ara l- Fuljett ta ’ Tagħrif.
This veterinary medicine has been developed especially for dogs and is not for use in humans.
Din il- mediċina veterinarja ġiet żviluppata apposta għall- klieb u m’ għandhiex tintuża fuq il- bnedmin.
Although skin contact with the product is unlikely, if this occurs the exposed area should be washed immediately, as these types of substances may be absorbed through the skin.
Għalkemm il- kuntatt mal- ġilda b’ dan il- prodott m’ huwiex probabbli, jekk dan iseħħ, il- parti esposta għandha tiġi mlaħalħa minnufih, minħabba li dawn it- tipi ta ’ sustanzi jistgħu jiġu assorbiti fil- ġilda.
Pregnant women should not administer the product.
Nisa tqal ma għandhomx jagħtu dan il- prodott.
When administering the product, care should be taken to avoid accidental self-injection by ensuring that animals are suitably restrained and that the application needle is shielded until the moment of implantation.
Meta wieħed ikun qed jagħti dan il- prodott, għandha tingħata attenzjoni li ma jinjettax lilu nnifsu b’ mod aċċidentali billi jagħmel żgur li l- annimali jkunu mrażżna b’ mod adegwat u li l- labra ta ’ l - applikazzjoni tkun mgħottija sal- mument ta ’ l- impjantazzjoni.
In case of accidental self-injection, medical advice should be sought immediately and the Package Leaflet or the label shown to the doctor.
Fil- każ li wieħed jinjetta lilu nnifsu b’ mod aċċidentali, wieħed għandu jfittex parir mediku minnufih u għandu juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Suprelorin been approved?
Għaliex ġie approvat Suprelorin?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suprelorin outweigh its risks for the induction of temporary infertility in healthy, entire, sexually mature male dogs and recommended that Suprelorin be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Suprelorin jisbqu r- riskji tiegħu għall- induzzjoni ta ’ infertilità temporanja fi klieb irġiel b’ saħħithom, sesswalment maturi u jirrikmanda li Suprelorin jingħata awtorizzazzjoni biex jitqiegħed fis- suq.
The benefit- risk balance may be found in module 6 of this EPAR.
Il - bilanċ bejn il- benefiċċju u r- riskju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Suprelorin:
Informazzjoni oħra dwar Suprelorin:
The European Commission granted a marketing authorisation valid throughout the European Union, for Suprelorin to Cyton Biosciences on 10/ 07/ 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Suprelorin lil Cyton Biosciences fil- 10/ 07/ 2007.
Information on the prescription status of this product may be found on the label/ outer package.
Wieħed jista ’ jsib informazzjoni fuq l - istatus tal- preskrizzjoni fit- tikketta/ pakkett ta ’ barra.
This summary was last updated in July 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Lulju 2007.
Withdrawal Period
Perjodu ta 'Tiżmin
4.7 mg
4. 7 mg
Sealed foil pouch in cardboard carton
Użu għal taħt il- ġilda
2 implants
Pawċ tal- fojl 2 impjanti issiġġikkat f' kartuna tal - kardbord
2 implants preloaded in implanters + 1 actuator
2 impjanti kkargati N/ A mill- ġdid fi strumenti biex jitwaħħal impjant + 1 maqbad
5 implants
Pawċ tal- fojl 5 impjanti issiġġikkat f' kartuna tal - kardbord
5 implants preloaded in implanters + 1 actuator
5 impjanti kkargati N/ A mill- ġdid fi strumenti biex jitwaħħal impjant + 1 maqbad
Suprelorin 4.7 mg implant for dogs
Suprelorin 4. 7 mg impjant għal- klieb
4.7 mg deslorelin (as deslorelin acetate)
4. 7 mg deslorelin (bħala deslorelin acetate)
Excipient(s):
Sustanzi mhux attivi:
Implant White to pale yellow cylindrical implant.
Impjant Impjant ċilindriku abjad li jagħti fl- isfar ċar.
Dogs (Male).
Klieb (Irġiel).
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
Għall- induzzjoni ta ’ infertilità temporanja fi klieb irġiel f’ saħħithom, sħaħ, u sesswalment maturi.
Infertility is achieved from 6 weeks up to at least 6 months after initial treatment.
L- infertilità tinkiseb minn 6 ġimgħat sa ta ’ lanqas 6 xhur wara t- trattament inizjali.
Treated dogs should therefore still be kept away from bitches on heat within the first six weeks after initial treatment.
Għalhekk, klieb ittrattati għandhom xorta jinżammu ’ l bogħod minn klieb nisa sħan matul l- ewwel sitt ġimgħat wara t- trattament inizjali.
One out of 75 dogs treated with the product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Wieħed minn 75 kelb ittrattati b’ dan il- prodott waqt il- provi kliniċi tgħammar u ntrabat ma ’ kelba sħuna fi żmien sitt xhur ta ’ l- impjantazzjoni, iżda dan ma rriżultax fi tqala.
Should a treated dog mate with a bitch between six weeks and six months after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Jekk kelb jitgħammar ma ’ kelba bejn sitt ġimgħat u sitt xhur wara t- trattament, għandhom jittieħdu miżuri adattati biex jiġi eliminat ir- riskju ta ’ tqala.
Any mating that occurs more than six months after the administration of the product may result in pregnancy.
Kull tgħammir li jseħħ aktar minn sitt xhur wara t- tqegħid tal- prodott jista ’ jirriżulta fi tqala.
However, it is not necessary to keep bitches away from treated dogs following subsequent implantations, provided that the product is administered every six months.
Madankollu, mhuwiex neċessarju li żżomm klieb nisa ’ l bogħod minn klieb ittrattati wara impjantazzjonijiet sussegwenti, kemm- il darba dan il- prodott jingħata kull sitt xhur.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the product, has not been investigated.
Wara l- għoti tal- prodott, il- ħila ta ’ klieb li jsiru missirijiet ta ’ ġriewi wara li l- livelli ta ’ testosterone fil - plażma jiġu lura għan- normal, ma ġietx investigata.
2 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.
2 Fir- rigward ta 'livelli ta ’ testosterone (marka stabbilita sostituta għal kejl tal- fertilità), waqt provi kliniċi, aktar minn 80% ta ’ klieb li tqegħdilhom impjant wieħed jew aktar, irritornaw għal- livelli normali ta ’ testosterone fil- plażma (≥0. 4 ng/ ml) fi żmien 12- il xahar mill- impjantazzjoni.
Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Tmienja u disgħin fil- mija tal- klieb irritornaw għall- livelli normali ta ’ testosterone fil- plażma fi żmien 18- il xahar mill- impjantazzjoni.
However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after six months, or repeated implantation, are limited.
Madankollu, tagħrif li juri r- riversibilità kompluta ta ’ l- effetti kliniċi (tnaqqis fid - daqs testikolari, tnaqqis fil- volum tas- semen, tnaqqis fil- għadd tal- isperma u tnaqqis fil- libido) li jinkludi l- fertilità wara sitt xhur, jew impjantazzjoni rrepetuta, huwa ristrett.
During clinical trials, most of the smaller size dogs (< 10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Waqt provi kliniċi, il- parti l- kbira tal- klieb ta ’ statura iżgħar (< 10 kg) żammew livelli ta ’ testosterone imrażżna għal aktar minn 12- il xahar wara l- impjantazzjoni.
For very large dogs (> 40 kg), data are limited but duration of testosterone suppression was comparable to that seen in medium and large dogs.
Għal klieb kbar ħafna (> 40 kg) it- tagħrif huwa ristrett iżda t- tul ta ’ żmien ta ’ trażżin ta ’ testosterone kien komparabbli ma ’ dak li jidher fi klieb ta ’ daqs medju u kbir.
The use of the 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.
Għaldaqstant, l- użu tal- prodott fi klieb ta ’ piż tal- ġisem ta ’ anqas minn 10 kg jew aktar minn 40 kg, għandu jkun suġġett għal stima ta ’ riskju/ benefiċċju magħmula minn veterinarju.
The use of the product in pre-pubertal dogs has not been investigated.
L- użu tal- prodott fi klieb qabel il- pubertà ma ġiex mistħarreġ.
It is therefore recommended that dogs should be allowed to reach puberty before treatment with the product is initiated.
Għalhekk huwa rakkomandat li l- klieb jitħallew jilħqu l- pubertà qabel ma jinbeda t- trattament bil- prodott.
Data demonstrate that treatment with the product will reduce the libido of the dog, but other behavioural changes (e. g. male-associated aggression) have not been investigated.
It- tagħrif juri li trattament bil- prodott inaqqas il- libido tal- kelb, iżda bidliet oħra fl- imġiba (eż. aggressjoni relatata mar- raġel) ma ġewx mistħarrġa.
Pregnant women should not administer the product.
Nisa tqal m’ għandhomx jamministraw il- prodott.
Another GnRH analogue has been shown to be foetotoxic in laboratory animals.
Analogu ieħor ta ’ GnRH ieħor ġie muri li huwa fetotossiku f’ annimali fil- laboratorju.
Specific studies to evaluate the effect of deslorelin when administered during pregnancy have not been conducted.
Ma sarux studji speċifiċi biex jevalvaw l- effett ta ’ deslorelin meta jkun amministrat waqt it- tqala.
Although skin contact with the product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin.
Għalkemm kuntatt mal- ġilda bil- prodott mhuwiex probabbli, jekk dan iseħħ, aħsel fil- pront il- parti esposta, għaliex analogi ta ’ GnRH jistgħu jiġu assorbiti mill- ġilda.
When administering the 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.
Meta tkun qiegħed tamministra l- prodott, oqgħod attent li tevita li tinjetta lilek innifsek aċċidentalment billi tiżgura li l- annimali jkunu mrażżna kif jixraq u li l- labra li biha jingħata tkun imħarsa sal- mument ta ’ l- impjatazzjoni.
In case of accidental self-injection, seek medical advice immediately, with a view to having the implant removed.
F’ każ li tinjetta lilek innifsek aċċidentalment, fittex parir mediku fil- pront, bil- għan li jitneħħielek l- impjant.
Show the package leaflet or the label to the physician.
Uri l- fuljett tat- tagħrif jew it- tiketta lit- tabib.
Moderate swelling at the implant site may be observed for 14 days.
Nefħa moderata fis- sit ta ’ l- impjant tista ’ tiġi osservata għal 14- il jum.
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.
Ħistoloġikament, reazzjonijiet lokali ħfief b’ infjammazzjoni kronika tat- tessut konnettiv u xi formazzjoni ta ’ kapsula u depożitu ta ’ kollaġen kienu jidhru wara tlett xhur ta ’ l- amministrazzjoni.
A significant decrease in testicle size will be seen during the treatment period.
Id- daqs tat- testikoli jiċkien b’ mod sinifikattiv waqt il- perijodu tat- trattament.
In very rare cases, a testicle may be able to ascend the inguinal ring.
F’ każijiet rari ħafna, it - testikola tkun tista ’ titla miċ- ċirku ingwinali.
3 4.8 Interaction with other medicinal products and other forms of interaction
3 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
The recommended dose is one implant per dog, irrespective of the size of the dog.
Id- doża rakkomandata hija impjant wieħed għal kull kelb, irrispettivament mid- daqs tal- kelb.
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction of infection.
Is- sit ta 'l- impjantazzjoni għandu jiġi diżinfettat qabel l- impjantazzjoni biex tiġi evitata l- introduzzjoni ta ’ infezzjoni.
If the hair is long, a small area should be clipped, if required.
Jekk is- suf ikun twil għandha tiġi mqaxxra parti żgħira mill- ġilda, jekk meħtieġ.
Remove Luer Lock cap from the implanter.
Neħħi t- tapp Luer Lock mill- istrument li jintuża sabiex jitwaħħal impjant.
Attach the actuator to the implanter using the Luer Lock connection.
Waħħal il- parti minn fejn jingħata l- impjant ma ’ l- istrument biex jitwaħħal impjant, billi tuża l- konnessjoni Luer Lock.
The product should be implanted subcutaneously in the loose skin on the back between the lower neck and the lumbar area.
Il- prodott għandu jiġi impjantat taħt il- ġilda, fil- ġilda mlaħalħa ta ’ fuq id- dahar bejn il- parti t’ isfel ta ’ l- għonq u l- parti tal- ġenbejn.
Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
Evita l- injezzjoni ta ’ l- impjant ġox- xaħam, peress li l- ħelsien tas- sustanza attiva jista ’ jkun imxekkel f’ partijiet b’ vaskularizzazzjoni baxxa.
Lift the loose skin between the shoulder blades.
Għolli l- ġilda bejn l- għadam ta ’ l - ispallel.
Insert the entire length of the needle subcutaneously.
Daħħal it- tul kollu tal- labra taħt il- ġilda.
Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
Niżżel kompletament il- planġer u, fl- istess ħin iġbed lura l- labra bil- mod.
Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.
Agħfas il- ġilda fis- sit fejn ingħatat l- injezzjoni waqt li tkun qiegħed tneħħi l - labra, u żomm magħfus għal 30 sekonda.
Examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
Eżamina s- siringa u l- labra biex tassigura li l- impjant ma baqax fis- siringa jew fil- labra, u li l- ispejser jidher.
It may be possible to palpate the implant in situ.
Jista ’ jkun possibbli li tħoss l- impjant in situ.
Repeat administration every six months to maintain efficacy.
Irrepeti l- għoti kull sitt xhur sabiex tibqa 'tinżamm l- effikaċja.
Do not use the product if the foil pouch is broken.
Tużax il- prodott jekk il- pawċ tal- folja ikun imqatta ’.
The biocompatible implant does not require removal.
L- impjant huwa bijokompatibbli u mhux meħtieġ li jitneħħa.
However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian.
Madankollu, jekk ikun meħtieġ li jitwaqqaf it- trattament, l- impjanti jistgħu jitneħħew kiruġikament minn veterinarju.
Implants may be located using ultrasound.
L- impjanti jistgħu jiġu lokalizzati permezz ta ’ mewġ ultrasoniku.
No adverse reactions have been observed following simultaneous subcutaneous administration of up to 10 implants.
L- ebda reazzjonijiet avversi ma ġew osservati wara t- tqegħid sa 10 impjanti f’ salt taħt il- ġilda.
4.11 Withdrawal period(s)
4. 11 Perjodu ta 'tiżmin
Gonadotrophin-releasing hormones (GnRH), ATCvet code:
Ormoni li jerħu gonadotrofin (GnRH), Kodiċi ATC veterinarja:
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
L- agonista ta ’ GnRH, deslorelin, jaħdem billi jrażżan il- funzjoni ta ’ l- assi pitwitarju- gonadali meta jkun applikat f’ doża baxxa kontinwa.
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.
Dan it- trażżin jirriżulta fil- falliment ta ’ l- annimali trattati li jissintetizzaw u/ jew jerħu follicle stimulating hormone (FSH) u luteinising hormone (LH), l- ormoni li huma responsabbli għaż- żamma tal- fertilità.
4 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.
4 Id- doża baxxa u kontinwa ta ’ deslorelin tnaqqas il- funzjonalità ta ’ l- organi riproduttivi tar- raġel, il- libido u l- ispermatoġenesi u tnaqqas il- livell ta ’ testosterone fil- plażma, minn 4- 6 ġimgħat wara l- impjantazzjoni.
A short transient increase in plasma testosterone may be seen immediately after implantation.
Żieda ta ’ testosterone fil- plażma għal żmien qasir u li jgħaddi, tista ’ tiġi murija immedjatament wara l- impjantazzjoni.
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 product.
Kejl ta ’ konċentrazzjonijet ta ’ testosterone fil- plażma wera l - effett farmakoloġiku persistenti tal- preżenza kontinwa ta ’ deslorelin fiċ- ċirkulazzjoni għal ta ’ l- anqas sitt xhur wara t- tqegħid tal- prodott.
It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Il- livelli ta ’ deslorelin fil- plażma ġew murija li jilħqu l- quċċata minn 7 sa 35 jum, wara t- tqegħid ta ’ impjant li jkun fih 5 mg deslorelin radjutikkettat.
The substance can be directly measured in the plasma up to approximately 2.5 months post implantation.
Is- sustanza tista ’ tiġi mkejla direttament fil- plażma għal madwar xahrejn u nofs wara l- impjantazzjoni.
The metabolism of deslorelin is rapid.
Il- metaboliżmu ta ’ deslorelin huwa rapidu.
Hydrogenated palm oil Lecithin Sodium acetate anhydrous
Żejt tal- palma idroġeniżżat Leċitina Aċetat tas- sodjum anidru
The implant is supplied in a pre-loaded implanter.
L- impjant jiġi fornut fi strument apposta sabiex jitqiegħed l- impjant, ikkargat bil- lest.
Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised.
Kull tali strument huwa ppakkjat f' pawċ issiġillat tal- fojl, li sussegwentement jiġi sterilizzat.
The final sales presentation consists of a 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.
Il- preżentazzjoni finali li tkun għal bejgħ tikkonsisti minn kaxxa tal- kartuna li fiha żewġ jew ħames strumenti biex jitwaħħal l- impjant, mgewżra individwalment fil- fojl u li ġew sterilizzati, flimkien ma 'strument mhux sterlizzat sabiex jitpoġġa l- impjant (planġer).
The actuator is attached to the implanter using the Luer Lock connection.
Dan l- istrument jiġi mwaħħal ma ’ l- istrument li fih hemm l- impjant permezz ta ’ konnessjoni Luer Lock.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li rriżultaw minn l- użu ta ’ din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
The actuator can be re-used.
Il- planġer jista 'jerġa jintuża.
06516 Carros France
06516 Carros FRANZA
14 December 2007
< Data tad- Deċiżjoni tal- Kummissjoni >
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediċinali veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. < MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
7 A. < MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U > SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manufattur( i) responsabbli mill- ħruġ tal- lott.
Hay-on-Wye HR3 5PG United Kingdom
Hay- on- Wye HR3 5PG Ir- Renju Unit
CARDBOARD CARTON
Kaxxa tal- kartuna
2 implants preloaded in implanters + 1 actuator 5 implants preloaded in implanters + 1 actuator
2 impjanti kkargati fi strumenti biex jitqiegħdu l- impjanti + planġer 5 impjanti kkargati fi strumenti biex jitqiegħdu l- impjanti + planġer
For the induction of temporary infertility in healthy male dogs.
Għall- induzzjoni ta ’ infertilità temporanja fi klieb irġiel b’ saħħithom.
Do not use if the foil pouch is broken.
Tużax jekk il- pawċ tal- fojl ikun imqatta ’.
Administer one implant only.
Amministra impjant wieħed biss.
The implant should be administered subcutaneously between the shoulder blades of the dog.
L- impjant għandu jiġi amministrat taħt il- ġilda, bejn l- għadam ta 'l- ispallejn tal- kelb.
Read the package leaflet before use
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li rrżultaw minn użu ta ’ din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL "
FOIL POUCH
PAWĊ TAL- FOJL
One implant preloaded in one implanter.
Impjant wieħed imqiegħed għal lest fi strument sabiex jitpoġġa.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL TRATTAMENT TA 'L- ANNIMALI BISS ”
14 PACKAGE LEAFLET Suprelorin 4.7 mg implant for dogs
14 FULJETT TA 'TAGĦRIF FIL- PAKKETT Suprelorin 4. 7 mg impjant għal- klieb
Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin acetate).
Suprelorin huwa impjant ċilindriku abjad fl- isfar ċar, li fih 4. 7 mg deslorelin (bħala deslorelin acetate).
For the induction of temporary infertility in healthy, non-castrated, sexually mature male dogs.
Għall- induzzjoni ta ’ infertilità temporanja fi klieb irġiel f’ saħħithom, mhux kastrati, u sesswalment maturi.
Moderate swelling at the implant site may be observed for 14 days.
Nefħa moderata fis- sit fejn jitqiegħed l- impjant tista ’ tiġi osservata għal 14- il jum.
Administer one implant only, irrespective of the size of the dog.
Amministra impjant wieħed biss, ikun xi jkun id- daqs tal- kelb.
Repeat treatment every 6 months to maintain efficacy.
Irrepeti t- trattament kull 6 xhur sabiex iżżomm l- effikaċja.
Do not use the product if the foil pouch is broken.
Tużax il- prodott jekk il- pawċ tal- fojl ikun imqatta ’.
One implant should be administered subcutaneously between the shoulder blades of the dog.
L- impjant għandu jiġi mogħti taħt il- ġilda bejn l- għadam ta 'l- ispallejn tal- kelb.
Remove Luer Lock cap from the implanter.
Neħħi t- tapp Luer Lock mill- istrument li jintuża sabiex jitwaħħal l- impjant.
Attach the actuator to the implanter using the Luer Lock connection.
Waħħal il- parti minn fejn jingħata l- impjant ma ’ l- istrument biex jitwaħħal impjant billi tuża l- konnessjoni Luer Lock.
Select the implant site by locating the area of the back midway between the shoulder blades.
Agħżel is- sit ta 'l- impjant billi tillokalizza post fuq id- dahar fin- nofs bejn l- għadam ta' l- ispallejn tal- kelb.
If the hair is long, a small area may be clipped, if required.
Jekk is- suf ikun twil, għandha titqaxxar parti żgħira, jekk meħtieġ.
Lift the loose skin between the shoulder blades.
Għolli l- ġilda bejn l- għadam ta ’ l- ispallel.
Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.
Agħfas il- ġilda fis- sit fejn ingħatat l- injezzjoni waqt li tkun qiegħed tneħħi l- labra, u żomm magħfus għal 30 sekonda.
Examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
Eżamina s - siringa u l- labra biex tassigura li l- impjant ma baqax fis- siringa jew fil- labra, u li l- ispejser jidher.
Implants may be located using ultrasound.
L- impjanti jistgħu jiġu lokalizzati permezz tal- mewġ ultrasoniku.
Store in a refrigerator (2°C – 8°C) Do not freeze
Tiffriżax.
Do not use after the expiry date which is stated on the carton.
Tużax wara d- data tal- iskadenza dikjarata fuq il- kartuna.
When administering the 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.
Meta tkun qiegħed tamministra l- prodott, oqgħod attent li tevita li tinjetta lilek innifsek aċċidentalment billi tiżgura li l- annimali jkunu mrażżna kif jixraq u li l- labra ta ’ biha jingħata tkun imħarsa sal - mument ta ’ l- impjatazzjoni.
Show the package leaflet or the label to the physician.
Uri l- fuljett tat- tagħrif jew it- tikketta lit- tabib.
Treated dogs should therefore still be kept away from bitches on heat within the first six weeks after initial treatment.
Għalhekk, klieb ittrattati għandhom xorta jinżammu ’ l bogħod minn klieb nisa sħan matul l- ewwel sitt ġimgħat wara t- trattament initzjali.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the product, has not been investigated.
Wara, l- għoti tal- prodott il- ħila ta ’ klieb li jsiru missirijiet ta ’ ġriewi wara li l- livelli ta ’ testosterone fil - plażma jiġu lura għan- normal, ma ġietx investigata.
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.
Fir- rigward ta 'livelli ta ’ testosterone (marka stabbilita sostituta għal kejl tal- fertilità), waqt provi kliniċi aktar minn 80% ta ’ klieb li tqegħdilhom impjant wieħed jew aktar, irritornaw għal- livelli normali ta ’ testosterone fil- plażma (≥0. 4 ng/ ml) fi żmien 12- il xahar mill- impjantazzjoni.
Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Tmienja u disgħin fil- mija tal- klieb irritornaw għal- livelli normali ta ’ testosterone fil- plażma fi żmien 18- il xahar mill- impjantazzjoni.
However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after six months, or repeated implantation, are limited.
Madankollu, tagħrif li juri r- riversibilità kompluta ta ’ l- effetti kliniċi (tnaqqis fid- daqs testikolari, tnaqqis fil- volum tas- semen, tnaqqis fil- għadd ta ’ l- isperma) li jinkludi l- fertilità wara sitt xhur, jew impjantazzjoni rrippetuta, huwa ristretta.