qanastek/EMEA-V3 huggingface dataset:
The elimination half-life (T1/ 2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/ kg BW are 4.9 h and 6.8 h, respectively.
Il- ħin tal - eliminazzjoni (T1/ 2) u Mean Residenċe Time tal- prodott wara trattament intraperitonjali fis- salamun ta ’ 32 mikrogramma / kilogramma piż ħaj huma 4. 9 siegħat u 6. 8 siegħat rispettivament.
6.1 List of excipients
6. 1 Lista ta ’ eċċipjenti
Benzyl alcohol Sodium acetate (tri-hydrate) Acetic acid, glacial Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
Benzyl alkoħol
4/ 37 Water for injection
4/ 37 Aċitat tas- sodju (tri- hydrate) Aċidu aċetiku, glaċjali Benzyl alkoħol Kloridu tas- sodju Sodium hydoxide / Aċidu idrokloridu 4N (għall- aġġustament tal- pH)
6.2 Incompatibilities
Ilma għall- injezzjoni
Shelf life of the veterinary medicinal product as packaged for sage:
Fin- nuqqas ta ’ studji dwar kompattibilita, dan il- prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
3 years.
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
28 days.
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: Tliet snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar: 28 jum
Shelf life after dilution according to directions: the product should be used immediately.
Żmien li l- prodott jibqa 'tajjeb wara li jiġi dilwit skond l- istruzzjonijiet fuq il- pakkett: il- prodott għandu jintuża mill- ewwel
Do not freeze.
Aħżen u ttrasporta f' temperatura ta ’ 2°Ċ – 8°Ċ (fil- friġġ) Tiffriżax
6.5 Nature and composition of immediate packaging
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm go fih
1 concentrate vial and 1 solvent vial.
Pakkett: kunjett wieħed tal- konċentrat u wieħed tas- solvent.
3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
Kunjett tal- konċentrat: kunjett ta ’ 3 ml magħmul minn ħġieġ kannella li fih 2 ml ta ’ soluzzjoni likwida, tapp tal- lastiku u crimp cap.
100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
Kunjett tas - solvent: kunjett ta ’ 100 ml magħmul minn ħġieġ ċar li fiha 100 ml likwidu, tap tal- lastiku u crimp cap
50-ml empty
Kontenitur sterili vojt ta ’ 50 ml
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Tagħrif għall- użu u maniġġjar u għar- rimi tal- mediċina mhux użata jew materjal ieħor jekk ikun il- każ
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 gietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- ligi tal- pajjiż.
MARKETING AUTHORISATION HOLDER
IS- SID TAL- AWTORIZZAZZJONI TAL- KUMMER.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International Wim de Korverstraat 35 5831 AN Boxmeer Olanda.
MARKETING AUTHORISATION NUMBER(S)
Numru ta ’ Awtorizzazzjoni biex jitpoġġa fis- Suq
9.
5/ 37 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Data tal- ewwel Awtorizzazzjoni / Tigdid tal- Awtorizzazzjoni
DATE OF REVISION OF THE TEXT
Data ta ’ meta ġiet riveduta din il- kitba
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 fuq dan il- prodott veterinarju tinsab fuq il- website tal - Agenzija Ewropeja tal - Mediċina (EMEA) http: // www. emea. europa. eu
Gonazon 18.5 mg implant for dogs
Gonazon 18. 5 mg impjant għall- klieb
Azagly-nafarelin
Azagly- nafarelin
18.5 mg per implant
18. 5 mg kull impjant
For a full list of excipients see section 6.1
Għal lista sħiħa ta eċċipjenti ara sezzjoni 6. 1
Gonazon implant is a solid, off white, 14x3x1 mm implant.
Gonazon huwa impjant solidu, off white, 14 x 3 x 1 mm impjant.
Dogs (bitches)
Klieb (tas- sess femminili)
Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
Jipprevjeni il- funzjoni tal- gonadi permezz li jimblokka is- sintesi tal- gonadotrofina fit- tul.
Do not use in bitches (prepubertal and adult) intended for breeding (see section 4.7).
Tuzax fi klieb tas- sess femminili (qabel il- puberta u adulti) li huma intenzjonati għat- tgħamir (ara sezzjoni 4. 7).
Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of treated bitches.
Evidenza ibbażata fuq informazzjoni miġbura bil- prattika, l- impjant jista ’ ma jinżammx f’ numru ta’ kelbiet (1. 2%) trattati.
If the implant cannot be palpated in the month following administration, the owner is encouraged to seek veterinary advice as efficacy cannot be ensured in these cases.
Jekk l- impjanti ma jkunx jista jinħass wara xhar li ġie impjantat, is- sid għandu jieħu l- parir tal- veterinarju għax f’ dawn l - każijiet l- effikaċċja tal- prodott mihiex garantita.
At the end of a one year treatment, it may not be possible to locate and remove the implant in approximately 10% of cases.
Wara sena ta’ trattament, f’ xi 10% tal- każijiet l- impjant ma jibqax jinħass u ma jkunx jista jitneħħa.
To minimise this problem, caution needs to be exercised to ensure that the implant is administered by subcutaneous injection, particularly in dogs with pronounced depots of subcutaneous fat.
Biex titnaqqas din l- problema, attenzjoni għandha tingħata biex l- impjant jiġi amministrat taħt il - ġilda., speċjalment f’ dak il- klieb li għandhom ħafna depożiti ta xaħam taħt l- ġilda.
Inability to locate and remove Gonazon will not have serious effects on the general health of the dog.
Jekk Gonazan ma jinstabx u ma jitneħħiex xorta m ’ għandux effeti serji fuq saħħet l- kelb.
However, the timing of return to heat cannot be predicted.
Iżda, l- ħin ta’ meta terġa tiġi s - saħna ma jistax jiġi previst.
Following a single administration, return to ovarian activity after implant removal may take longer in bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68 days, range 12 to 264 days).
Wara amministrazzjoni waħda, l- ovarji jistgħu jdumu aktar ma jiġu attivi wara li jitneħħa l- impjant f’ kelbiet trattati qabel il- puberta (medja 255 ġranet, perjodu bejn 36- 429 ġranet) milli kelbiet adulti (medja 68 ġranet, perjodu bejn 12 - 264 ġranet).
A large proportion (68%) of the first heat after a single treatment in adult bitches were non-ovulatory.
Proporzjon għoli (68%) ta ’ kelbiet adulti ma jovulawx fl- ewwel saħna wara trattament wieħed.
In addition following a repeat treatment, the timing of a return to heat cannot be accurately predicted.
Barra minn hekk, is- saħna ma tistax tiġi akkuratament prevista jekk it- trattament jiġi ripetut.
No data are available on repeat treatments in prepubertal bitches.
M’ hemmx informazzjoni fuq trattamenti ripetuti f’ kelbiet ta ’ qabel il- puberta.
Accidental ingestion of the implant by the dog will not affect its health, since the oral bio-availability of GnRH agonists is very low.
Jekk l- impjant jiġi inġerit mill- kelb aċċidentalment, dan m ’ għandux effett fuq saħħtu għax il - biodisponibiltà tal- agonisti tal- GnRh huwa baxx ħafna.
7/ 37 4.5 Special precautions for use
7/ 37 4. 5 Prekawzjonijiet Speċjali għall- Użu
Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
Trattament fil- proestrus ma jżommx milli jseħħ dik is- saħna partikolari (proestrus u oestrus)
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of giant breeds over 45 kg bodyweight.
Fin- nuqqas ta’ informazzjobi klinika, titrattax kelbat ta’ anqas mit- 3 kg piż ħaj u kelbat ta ’ razzez kbar li jaqbżu l- 45 kg piż ħaj.
In adult bitches, heat is commonly induced in the first month following the first administration of the implant.
F’ kelbat adulti, hija komuni li s- saħna tiġi indotta wara l- ewwel xahar li ġie amministrat l- ewwel impjant.
The frequency of induced heat is lower when the first treatment is administered in metoestrus (32%) than in anoestrus (84%).
Il- frekwenza ta’ namra indotta fi metoestrus (32%) hija anqas minn dik anoestrus( 84%).
Therefore, the first treatment should preferably be administered in metoestrus.
Għalhekk l- ewwel trattament preferribilment jingħata f’ metoestrus.
The incidence of induced heat following administration of a repeat treatment to bitches that have not shown signs of oestrus following a previous administration of the product is low (estimated to be 8%).
L- inċidenza ta ’ saħna ndotta hija baxxa (stmata li hi 8%) f’ kelbat li t- trattament ġie ripetut u li ma kellhom l- ebda sinja ta’ estru fl- ewwel trattament.
The risk of inducing a fertile heat is low in metoestrus (5%).
Ir- riskju li tiġi ndotta saħna fertili huwa baxx f’ metoestrus( 5%).
Administration of Gonazon at other stages of the cycle may induce heat that may be fertile.
Amministrazzjoni ta’ Gonazon fi stadi oħra taċ- ċiklu jista ’ jinduċi saħna li tkun fertili.
If a bitch becomes pregnant following induced heat, embryonic resorption or abortion may occur.
Jekk wara s- saħna ndotta, il- kelba tinqabat tqila, l - embriju jista ’ jiġi risorbit jew abbortit.
Therefore, if heat is observed, contact with male dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male dogs) cease.
Għalhekk kull kuntatt ma klieb tas- sess maskili għandu jiġi evitat sakemm kull sinjal ta namra (nefħa tal vulva, tnixxija ta’ demm u attrazzjoni lejn klieb maskili) jieqfu.
Induced heat is not observed if treatment is started before puberty.
Saħna indotta ma ġietx osservata jekk it- trattament jingħata qabel l- puberta.
In addition, the frequency of induced heat is lower in younger bitches than in older bitches.
Barra minn hekk, l - frekwenza ta ’ saħna ndotta hija anqas f’ kelbat ta ’ eta`zgħira milli fi klieb ta’ eta` akbar.
A proportion of bitches that show induced heat may subsequently develop pseudopregnancy.
Numru ta’ kelbiet li urew saħna ndotta jistgħu jizviluppaw psewdo tqala.
However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater than in control (untreated) bitches.
L- inċidenza ta ’ psewdo tqala f’ kelbat trattati bbażati fuq informazzjoni miġbura, m’ humiex aktar minn kelbiet taħt kontroll (mhux trattati).
The product when administered at the recommended treatment dose is ineffective in bitches aged 7 years or older.
Il- prodott meta jiġi amministrat skond id- doża rakommandata huwa bla effett f’ kelbat ta ’ 7 snin jew akbar.
Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product.
Ilbies protettiv, li jikkonsiti f’ ingwanti, għandu jintlibes meta jiġi użat dan l- prodott.
In case of accidental self-administration of the implant, seek medical advice immediately and show the package leaflet or the label to the physician.
Evita li tinjettah lilek innifsek. F' każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il - pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis.
Minħabba l- attivita farmakoloġika (inħibizzjoni tal- produzzjoni tal- ormoni tas - sess), l - amministrazzjoni tal- agonisti GnRH jistgħu jiġu assoċjati ma ’ vaġinitis.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- tqala, fi żmien il- ħalib u l- bajd
The use is not recommended during pregnancy and lactation.
Mhux rakkomandat li jintuża fit- tqala u fi żmien il- ħalib.
Laboratory studies have shown that administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy (that is, pregnancy will be carried to full term with the birth of viable pups).
Studji fil- laboratorju urew li l - amministrazzjoni tal- prodott fil- bidu tat- tqala aktarx li ma jeffettwawx it- tqala (jigifieri, t- tqala tkompli ż- żmien kollu bit- twelid normali ta’ ġriewi).
The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
Dan il- prodott huwa kontra- indikat f’ kelbat intezzjonati biex jitgħammru (adulti u qabel l- puberta`) għax studji fil- laboratorju urew li fi klieb li ħadu 3 impjanti f’ daqqa fuq perjodu ta ’ 12- il xahar, kellhom tnaqqis fin - numru ta ’ ġriewi ħajjin sa zmien il- ftama, meta mqabbla ma grupp ta’ kontroll li ma ġiex trattat.
8/ 37 4.8 Interaction with other medicinal products and other forms of interaction
8/ 37 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes.
Azagly- nafarelin huwa peptide li jiġi prinċipalment degradat minn petidases u mhux mill- enzimi tas - cytochrome P- 450.
Therefore, drug interactions would not be expected to occur.
Għalhekk, effetti fuq mediċinali oħra mhux suppost li hemm.
In a limited laboratory study, co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated.
Fi studji limitati fil - laboratorju juru li l- amministrazzjoni ta Gonazon u progesragens li jaħdmu għal żmien qasir huwa tollerat tajjeb.
However, interactions with other medicinal products have not been investigated.
Effetti fuq mediċinali oħra ma ġiex investigat.
The recommended dose is one implant per bitch.
Id- doża rakkomandata hija impjant wieħed għal kull kelba.
The implant may be administered to bitches from the age of four months.
L- impjant jista jiġi amministrat lil kelbat li għandhom minn erba ’ xhur żmien.
In adult bitches, the first treatment should be administered preferably in metoestrus.
L- ewwel trattament f’ kelbat adulti għandu jingħata f’ metoestrus.
The duration of prevention of gonadal function is obtained as detailed in the table below:
Iż- żmien li l- funzjoni tal- gonadi tiġi mwaqqfa hija kif muriha fit- tabella hawn taħt:
Age at which treatment is started
Eta ’ meta beda t- trattament
4 months – 3 years old
4 xhur – 3 snin
3
3 - 6 snin
Average duration of blockade
Medja ta’ kemm idum wieqaf
12 months
12 xahar
11 months
11 xahar
(standard deviation)
(devjazzjoni standard)
(± 24 days)
(± 24 ġranet)
(± 93 days)
(± 93 ġranet)
Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and ≥ 90% of treated prepubertal bitches.
Evidenza ibbażata fuq informazzjoni miġbura bil- prattika, wara trattament wieħed, l- estru ġie prevenut għal 12- il xahar jew aktar f’ 75% tal- kelbat adulti and ≥ 90% fil- klieb qabel il- puberta`.
However, it should be noted that within the first month after treatment a proportion of treated bitches also experienced an induced heat (see section 4.5).
Wieħed irrid jinnota li fl- ewwel xahar wara ittrattament, numru ta ’ kelbat kellhom namra indotta (ara sezzjoni 4. 5).
The product, when administered at the recommended treatment dose, is ineffective in bitches aged seven years or older.
Dan il- prodott meta amministrat fid- doża rakkomandata, mhux effikaċi f’ kelbiet ta seba snin jew akbar.
In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus.
Fil- kelbiet li l- funzjoni tal- gonadi ġie mwaqqaf b’ suċċess għal perjodu ta ’ 12- il xahar, jista` jingħata t- tieni trattament f’ dak il- ħin biex ikompli jiġi inibit l- estru.
There are no data available for animals treated on more than two occasions.
M’ hemmx informazzjoni fuq annimali li ġew trattati għall- aktar minn darbtejn.
ADMINISTRATION:
AMMINISTRAZZJONI:
Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique.
Gonazon għandu jingħata taħt il- ġilda, fil- ħajt anterjuri taż- żaqq, fiż- żona taż- żokkra, b’ teknika asettika.
The method of administration is as follows:
Il- metodu tal- amministrazzjoni huwa kif ġej:
1.
4 cm2) anterjuri taż- żaqq in- naħa 1. addominali/ umbilikali għall- proċedura assettika.
Open the foil pouch using the pre-cut incision to remove the sterile injection device.
Iftaħ il- borża tal- fojl minn fejn hemm is- sinjal tal- qtugħ biex toħroġ l- istrument tal- injezzjoni sterilizzat.
Remove the needle cap.
Neħħi l- kappa tal- labbra.
Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the implant from the needle.
Mhemmx għalfejn tipprova tneħħi l- bżieżaq tal- arja bħal meta għandek injezzjoni likwida, għax jista jwassal biex joħroġ l- impjant minn ġol- labbra.
Using aseptic technique, raise a small piece of skin in the region of the dogs umbilicus.
B’ metodu assettiku, għolli ftit ġilda fin- naħa taż- żokkra tal- kelb.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion, subcutaneously.
Daħħal il- labbra taħt il - ġilda, b’ angolu ta’ 30 grad fil- ġilda mgħollija f’ moviment wieħed.
With your free hand, use the thumb grip to hold the injection device in position, and depress the plunger as far as it can go.
Bl- id il- ħielsa, żomm l- instrument tal- injezzjoni fil- pożizzjoni billi tuża s- sebgħa l- kbir, għafas l- plunger l- aktar l- isfel li jista ’ jinżel.
This retracts the needle and withdraws it, leaving the implant beneath the skin.
B’ hekk il- labbra tinġibed u tħalli l- impjant taħt il- ġilda.
Withdraw the needle from the skin.
Neħħi l- labbra minn taħt il- ġilda.
Ensure that the administration site is clean and dry.
Aċċerta ruħek li l- post tal- injezzjoni huwa nadif u xott.
Instruct the owner to keep the administration site clean and dry for 24 hours.
Avża lis- sid biex iżomm l- post tal - injezzjoni nadif u xott għal 24 siegħa.
Record the date of treatment in the clinical records of the animals.
Żomm d- data tat- trattament fir- rekords kliniċi tal- annimali.
9/ 37 REMOVAL:
9/ 37 TNEĦĦIJA:
Chemical restraint (sedation and/ or general anaesthesia) may be required for implant removal.
Jista ’ jkun hemm bżonn jiġi ristrett kimikament (sedat jew/ u anestesija ġenerali).
Position the dog as described for administration of the implant.
Poġġi l- kelb kif imfiehem għall - amministrazzjoni tal- impjant.
Locate the implant by gentle digital palpation of the administration site.
Illokalizza l- impjant billi delikatament tipressa bis- swaba l- post tal- amministrazzjoni.
Prepare the site for an aseptic technique.
Ħejji l- post għall- proċedura assettika.
After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the implant.
Wara li jingħata biżżejjed loppju (lokali), agħafas bil- mod bis- swaba naħa waħda ta l- impjant.
Make a stab incision, approximately 5 mm long, along the elevated near end of the implant.
Għamel qasma ta ’ madwar 5mm tul, fejn hemm l- parti mgħollija tal- impjant.
Push the implant gently towards the stab incision.
Imbotta l - impjant bil- mod in- naħa ta ’ fejn hemm il- qasma.
If necessary, dissect away any fibrous tissue to free the implant.
Jekk ikun hemm bżonn aqta kull tessut fibruż biex jiġi illiberat l- impjant.
Grasp it with forceps and remove.
Aqbad bil- forceps u neħħi.
Instruct the owner to keep the administration site clean and dry for 24 hours.
Avża lis- sid biex iżomm l- post tal- injezzjoni nadif u xott għal 24 siegħa.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta 'emerġenza, antidot), (jekk ikun hemm bżonn)
Risk of overdose is negligible owing to the type of formulation and administration (single dose implant for subcutaneous administration).
Riskju ta ’ doża eċċessiva huwa negliġiblli minħabba l- għamla farmaċewtika u l- mod ta ’ amministrazzjoni (impjant b ’ doża waħda għall- injezzjoni taħt il- ġilda).
Simultaneous administration of five implants during a one- year period was well tolerated.
Amministrazzjoni f’ sena ta ’ ħames impjanti f’ daqqa kien tollerat tajjeb.
4.11 Withdrawal period
4. 11 Perjodu ta ’ Tiżmim
Pharmacotherapeutic group:
Klassi farmakoterapewtika:
Gonadotrophin-Releasing Hormone (GnRH) ATCvet code:
Gonadotrophin- Releasing Hormone (GnRH) Kodici ATĊ veterinarja:
QH01CA
QH10CA
Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously.
Azagly- nafarelin, huwa un agonista GnRH, li meta jiġi amministrat kontinwament għandu effeti bifażiċi fuq il- glandola pitwitari.
Initially, it stimulates pituitary function and secretion of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone).
Għall- ewwel, jistimola l- funzjoni tal- glandola pitwitari u s - sekrezzjoni tal- gonadotropini LH (luteinising hormone) u FSH (follic stimulating hormone).
This brief phase may result in induced heat within one to four weeks following the first administration of the implant (see section 4.5).
Dan l - perjodu qasir, minn ġimgħa sa erbgħa ġimgħat wara l- ewwel amministrazzjoni tal- impjant (ara sezzjoni 4. 5), jista jistimola saħna.
Long- term administration results in pituitary desensitisation to the effects of GnRH resulting in a suppression of LH and FSH secretion by the pituitary.
Użu fit tul jirriżulta f’ desinsetazzjoni tal- glandola pitwitari li għandu effet fuq l- GnRH li jwassal għal waqfien tas- sekrezzjoni tal- LH u FSH mill- glandola pitwitari.
The transition between the stimulatory and inhibitory effects is completed within approximately one month.
Bħala konsegwenza ma jkunx hemm żvillup tal- follicle (u għalhekk l- estru ma jiġix osservat) u ma jkunx hemm ovulazzjoni. It- transizzjoni bejn l- effeti stimulanti u dawk inibituri jkun komplut f’ madwar xahar.
5.2 Pharmacokinetic particulars
TAGĦRIF FARMAKOKINETIKU
These maximal azagly-nafarelin concentrations are followed by a slow decline in circulating azagly-nafarelin concentrations lasting up to 12 months.
Wara amministrazzjoni ta’ impjant wieħed taħt il- ġilda tal- klieb (piż ħaj ta’ madwar 10kg), il- konċentrazzjoni massima (0. 13µg/ ml) ta’ azagly- nafarelin tiġi milħuqa madwar 3. 5 sigħat. Wara dawn il- konċentrazzjonijiet massimi ta ’ azagly- nafarelin, il- livelli li jiċċirkulaw jibdew jonqsu bil- mod u jservu sa sena.
The apparent volume of distribution of azagly-nafarelin following intravenous bolus administration, at a dose equivalent to the content of one implant, is 0.12 l/ kg.
Il- volum apparenti ta’ distrubuzzjoni ta ’ azagly- nafarelin wara li jiġi amministrat fil - vina f’ daqqa, f’ doża ekwivalenti tal- kontenut ta ’ impjant wieħed, huwa 0. 12 l/ kg.
Metabolism and excretion:
Metabolismu u eskrezzjoni:
The clearance of azagly-nafarelin following intravenous administration of the same dose is 0.46 l/ h and the elimination half-life is 1.8 hours.
It- tneħħija ta ’ azagly- nafarelin wara li jiġi amministrat fil- vina bl- istess doża, hija ta ’ 0. 46l/ siegħa u l- half- life hija 1. 8 siegħat.
10/ 37 6.
10/ 37 6.
6.1 List of excipients
6. 1 Lista ta ’ ingredjenti mhux attivi
Cured elastomer, resulting from the polymerisation of polydimethylsiloxane and tetrapropylorthosilicate in the presence of stannous octoate.
Cured elastomer, li huwa riżultat minn polimerizzazzjoni tetrapropylorhosilicate fil- preżenza ta ’ stannous octoate.
6.2 Incompatibilities
polydimethylsiloxane
Shelf life of the veterinary medicinal product as packaged for sale:
Dan il- prodott veterinarju ippakjat idum tajjeb:
Do not store above 25°C.
Taħżinx il- fuq minn 25°C.
Single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.
Strument wieħed sterili għal- injezzjoni li jintrema wara l- użu, ikkargat fis- siringa u mgħotti b’ tapp prottetiv.
The unit is sterile and comes in a sealed, light-proof, aluminium foil laminate pouch, packed in an individual carton box.
L- istrument huwa sterili u jiġi issiġillat f’ pakett tal- folja tal- aluminju, u ippakjat individwali f’ kaxxa tal- kartun.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali dwar ir- rimi ta 'prodotti mhux użati jew materjal ieħor għar - rimi
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 ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż
MARKETING AUTHORISATION HOLDER
SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International Wim de Korverstraat 35 5831 AN Boxmeer L - OLANDA
MARKETING AUTHORISATION NUMBER(S)
NUMRI TA 'AWTORIZZAZZJONI TAL- KUMMERĊ
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljat fuq dan il- prodott mediċinali veterinarju jinsab fuq il- website ta ’ l- Aġenzija Ewropeja tal- Mediċini (EMEA) http: // www. emea. europa. eu
PROHIBITION OF SALE, SUPPLY AND/ OR USE
11/ 37 PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
Not applicable.
Mhux applikabli
12/ 37 ANNEX II
12/ 37 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JHALLI L- KONSENJA TMUR FIS- SUQ.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET TAL – MANIFATTURA U RESTRIZZJONIJIET DWAR PROVVISTA U UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
RESTRIZZJONIJIET DWAR PROVVISTA U UŻU
STATEMENT OF THE MRLs
DIKJARAZZJONI TAL - MRL
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
L- ISEM U L- INDIRIZZ TAS- SID TAL- MANIFATTURA TAS - SUSTANZA BIOLOĠIKA U L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ.
Name and address of the manufacturer(s) responsible for batch release
Isem u l- indirizz tal- manifattur tas- sustanza/ i attiva bioloġika:
Gonazon for fish:
Isem u l- indirizz tal- manifattur responsabbli li jħalli l- konsenja tmur fis- suq:
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Olanda.
Gonazon for dogs:
Gonazon għall- klieb
Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Intervet GesmbH Siemensstrasse 107 A- 1210 Wien Awstrija.
Veterinary medicinal product subject to prescription.
Prodott Mediċinali Veterinarju li għandu jingħata bir- riċetta tal- veterinarju.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ l- Awtorizzazzjoni tal- Kummerċ irid javża lill- Kummisjoni Ewropeja dwar pjani ta ’ kummerċalizzazzjoni ta ’ dan il - prodott awtorizzat b ’ din id - deċiżjoni.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
RESTRIZZJONIJIET DWAR PROVVISTA U UŻU
STATEMENT OF THE MRLs
DIKJARAZZJONI TAL- MRL’ s
Substance Azagly-nafarelin
Azagly- nafarelin
MRL status Annex II for Salmonidae1
Anness II għall- ispeċi tas -
Comments Not for use in fish from which eggs are produced for human consumption
Mhux għall- użu f’ ħut li l -
Sodium acetate (tri-hydrate) Acetic acid (glacial) Benzyl alcohol
Sodium acetate (trihydrate)
Annex II for all food producing species Annex II for all food producing species Annex II for all food producing species.
Anness II għall- ispeċi kollha li jmorru għall- ikel
For use as excipient
Benzyl alcohol
Approved food additive (E 262), CR No 2034/ 96 Approved food additive (E 260), CR No 2034/ 96 CR No 1442/ 95
Anness II għall- ispeċi kollha li jmorru għall- ikel
Sodium chloride
Kloru tas- sodju
Annex II for all food producing species
Anness II għall- ispeċi kollha li jmorru għall- ikel
Sodium hydroxide Included in Annex II for all food producing species Hydrochloric acid Annex II for all food producing species, for use as excipient.
Anness II għall- ispeċi kollha li jmorru għall- ikel
Water for Not within the scope of injections Council Regulation 2377/ 90
Anness II għall- ispeċi kollha li jmorru għall- ikel, għal użu bhalha eċċipjent
Approved food additive (E 524), CR No 2034/ 96 CR No 1442/ 95
1442/ 95
1 Regulation 1530/ 02 / OJL230 of 28 August 2002
Mhux fl- iskop tar - Regolament tal- Kunsill 2377/ 90
15/ 37 ANNEX III
15/ 37 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U L- FULJETT INFORMATTIV
17/ 37 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Gonazon concentrate for solution for injection of female salmonid fish
Konċentrat għall- injezzjoni li jintuża fl- ispeċi femminili tas- salamun
VIAL CONTAINING CONCENTRATE:
Kunjett tal- konċentrat:
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagly – nafarelin 1600 mikrogrammi / ml bhal Azagly – nafarelin acetate
Excipients
Eċċipjent/ i
VIAL CONTAINING SOLVENT:
Kunjett li fih is- solvent:
Concentrate for solution for injection.
Soluzzjoni għal injezzjoni
Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent.
Pakkett li fih kunjett ta ’ 2 ml ta ’ konċentrat u flixkun li fih 100 ml ta ’ solvent.
An empty sterile mixing vial is supplied separately.
Hemm ukoll kunjett sterilizzat biex tħallat fih.
Additional sterile vials will be supplied on request.
Tista ’ titlob li jkollok aktar kunjetti biex tħallat fihom.
TARGET SPECIES
SPEĊI GĦAL X' HIEX HUWA NDIKAT IL- PRODOTT
Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus).
Speċi tas- Salamun tas- sess feminili bhas- Salamun tal- Atlantiku (Samo Solar), Trota tal- qawsalla (Onċorhynċhus mykiss), Trota kannella (Salmo Trutta) u t- Trota l- ħamra (Salvelinus Alpinus).
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Tfaqqis u sinkronizzazjoni ta ’ l - ovulazjoni għal- produzzjoni tal- bajd u friegħ tal- ħut.
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD TA ’ AMMINISTRAZZJONI
Read the package leaflet before use.
Aqra l- fuljett tal- informazzjoni qabel l- użu.
Zero days.
xejn
SPECIAL WARNING(S), IF NECESSARY
TWISSIJIET SPEĊJALI OĦRA, JEKK MEHTIEG
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin too early in the spawning season.
Tnaqqis fil- fertilita`, kwalita u sopravivenza tal- bajd ġiet osservata f’ ħut li ġie trattat b’ dan il - prodott.
It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
F’ xi każi dan seta ġara minħabba li l- prodott intuża kmieni ħafna fl- istaġun tal- bajd.
For Arctic charr, injections should be given only if the water temperature is < 8°C.
Huwa rakkomandat li wara l- injezzjoni il- ħut jiġi strippjat f’ intervall ta ’ madwar 50 – 100 gradi ġranet.
High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish.
Fil- każ ta ’ ħut tat- tip Arctic Charr, l- injezzjoni għandha tingħata biss meta t- temperatura ta ’ l - ilma hija < 8 ċentigradi.
The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
Għadu qatt ma ġie studjat l - effett fit- tul li dan il- prodott jista ’ jkollu fuq ħut tar- razza ttrattat.
Read the package insert before use.
Aqra l- fuljett informattiv qabel tuża l- prodott.
"Month/ Year" After dilution, the product should be used immediately.
Jiskadi {xahar / sena} Jekk thallat uża mil – ewwel.
Do not freeze.
Aħżen u ttrasporta f' temperatura ta ’ 2°Ċ – 8°Ċ (fil- friġġ) Tiffriżax.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL HAZIN IEHOR, JEKK IKUN IL- KAZ
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 ohra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ”
For animal treatment only - to be supplied only on veterinary prescription.
Għat- Trattament tal- annimali biss.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI BIEX JITPOĠĠA L - PRODOTT FIS- SUQ
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International BV
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- AWTORIZAZZJONI GĦALL- KUMMERĊ FIR- REGISTRU TAL - KOMUNITA`
< Batch > < Lot > < BN > {number}
< Lot > {numru}
20/ 37 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20/ 37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton Box
Kaxxa tal- kartun
Gonazon 18.5 mg implant for dogs
18. 5mg impjant għall- klieb
Azagly-nafarelin (18.5 mg)
Azagly- nafarelin (18. 5 mg)
One implant.
Impjant wieħed.
Dog (bitches)
Klieb (tas- sess femminili)
Read the package leaflet before use.
Amministrat taħt il- ġilda Aqra l- fuljett tal- informazzjoni qabel l- użu.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL HAZIN IEHOR, JEKK IKUN IL- KAZ
For animal treatment only - to be supplied only on veterinary prescription.
Għat- Trattament tal- annimali biss - jingħata biss fuq preskrizzjoni veterinarja.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Korverstraat 35 5831 AN Boxmmer Olanda
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- AWTORIZAZZJONI GĦALL- KUMMERĊ FIR- REGISTRU TAL - KOMUNITA
22/ 37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- KUNJETT
2 ml concentrate vials
Ta ’ 2 millilitri ta ’ konċentrat
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITA TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagly – nafarelin 1600 mikrogrammi / millilitru bhala azagly– nafarelin acetate.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BHALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
Intraperitoneal (IP) use
Intraperitonjali (IP)
< Batch > < Lot > {number}
< Lott > {numru}
EXP {month/ year} After dilution, the product should be used immediately.
Jiskadi {xahar/ sena} Wara li jitħallat, uża mill- ewwel.
For animal treatment only- to be supplied only on veterinary prescription.
Għat- Trattament tal- Annimali biss.
23/ 37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKJAR IMMEDJAT
Gonazon 18.5 mg implant for dogs
Gonazon 18. 5 mg imjant għall- klieb
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITA` TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Azagly-nafarelin
Azagly – nafarelin
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BHALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
Subcutaneous administration.
Taħt il- ġilda
Batch < number >
< Lott > {numru}
For animal treatment only.
Għat- Trattament tal- Annimali biss.
24/ 37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
24/ 37 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKJAR IMMEDJAT
Vial containing solvent
Kunjett li fih is- solvent
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
KWANTITA` TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
Excipients
Eċċipjenti:
Solvent for solution for injection.
Soluzzjoni għal injezzjoni
Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent.
Kaxxa tal- kartun li fiha kunjett wieħed ta ’ 2ml soluzzjoni konċentrata u flixkun tal- 100ml bis- solvent.
An empty sterile mixing vial is supplied separately.
Kunjett separat, vojt, għat- taħlit, setrili.
Additional sterile vials will be supplied on request.
Kunjetti addizzjoni jiġu mgħotija fuq rikjesta.
Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus).
Speċi tas- Salamun tas- sess feminili bħas- Salamun tal- Atlantiku (Samo Solar), Trota tal- qawsalla (Onċorhynċhus mykiss), Trota kannella (Salmo Trutta) u t- Trota l- ħamra (Salvelinus Alpinus).
Read the package leaflet before use.
Qabel tuża, aqra l- fuljett tal- informazzjoni.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin too early in the spawning season.
Tnaqqis fil- fertilita, kwalita u sopravivenza tal- bajd ġiet osservata f’ ħut li ġie trattat b’ dan il - prodott.
High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish.
25/ 37 Fil- każ ta ’ ħut tat- tip Arctic Charr, l- injezzjoni għandha tingħata biss meta t- temperatura ta ’ l - ilma hija < 8 ċentigradi.
Operators should wear gloves when mixing the concentrate solution with the solvent.
Uża ingwanti meta tħallat il- konċentrat mas- solvent.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament tal- annimali biss.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI BIEX JITPOĠĠA L - PRODOTT FIS- SUQ, U L- ISEM U L- INDIRIZZ TAS- SID TAL - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JHALLI L- KONSENJA TMUR FIS- SUQ FL- EEA, JEKK HUWA DIFFERENTI
17.
26/ 37 17.
27/ 37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
27/ 37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKJAR IMMEDJAT
Separate empty sterile containers
Kontenituri sterili vojta li jiġu separatament
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagly – nafarelin 1600 mikrogrammi / millilitru bħala azagly– nafarelin acetate
Read the package leaflet before use.
Aqra l- fuljett informattiv qabel tuża.
Zero days.
xejn ġranet
For animal treatment only
Għat- Trattament tal- Annimali biss.
29/ 37 PACKAGE LEAFLET Gonazon concentrate for solution for injection of female salmonid fish
29/ 37 FULJETT TA ’ TAGĦRIF Gonazon Konċentrat għall- injezzjoni li jintuża fl- ispeċi femminili tas- salamun
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ FL- EEA, JEKK HUWA DIFFERENTI
Marketing authorisation holder and manufacturer
IS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
Gonazon concentrate for solution for injection of female salmonid fish
Gonazon, Konċentrat għall- injezzjoni li jintuża fl- ispeċi femminili tas- salamun
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagly – nafarelin 1600 mikrogrammi / millilitru bħal Azagly – nafarelin acetate
Excipient:
Eċċipjenti:
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Tfaqqis u sinkronizzazjoni ta ’ l - ovulazjoni għall- produzzjoni tal- bajd u friegħ tal- ħut.
CONTRAINDICATIONS
KONTRA INDIKAZZJONI / JIET
The product should not be used in fish maintained in water temperatures that would normally inhibit ovulation as this can result in a decrease in egg quality.
Tużax dan il - prodott fuq ħut li jinżamm f ’ temperatura li jipprojbixxi l- ħut milli jovula għax inkella tista ’ tonqos il - kwalita` tal- bajd.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew xi effeti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI U METODU U MOD TA ’ AMMINISTRAZZJONI
9.
30/ 37 9.
ADVICE ON CORRECT ADMINISTRATION
PARIR FUQ AMMINISTRAZZJONI B’ MOD KORRETT
Inject intraperitoneally along the central line, 1/ 2 to 1 fin length in front of the pelvic fin base.
Injetta intraperitonjalment matul il- linja ċentrali, daqs nofs jew tul ta ’ ġewnaħ (tal- ħuta) quddiem il - post ma fejn hu mwaħħal il- ġewnaħ tan- naħa tal- pelvis.
The dose should be administered in the preferred volume for the particular body weight of fish.
Din id- doża għandha tiġi amministrata fil- volum adattat skond il- piż tal- ħuta partikulari.
The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the preferred injection volumes for fish of widely varying body weights.
Is- solvent ipprovdut għandu jintuża sabiex jiġi dilwit il- konċentrat u b’ hekk jittejjeb il- volum injettat li jiddependi fuq il - piż tal- ħuta njettata.
The table below provides the required volume of concentrate and the required volume of solvent to obtain thepreferred injection volumes of 0.1 ml/ kg fish, 0.2 ml/ kg fish, 0.5 ml/ kg fish or 1 ml/ kg fish.
It- tabella ta ’ hawn taħt turi l - volum ta ’ konċentrat u solvent li wieħed għandu bżonn sabiex jinjetta l - aħjar volum ta ’ 0. 1ml/ kg, 0. 2 ml/ kg, 0. 5 ml/ kg u 1. 0 ml/ kg ta ’ ħut.
Preferred injection volume per kg fish (depending on fish size) * Total kg of fish
L- aħjar volum injettat għal kull kilo ta ’ ħut (jiddependi fuq id - daqs tal- ħuta) Piż totali ta ’ Volum ta ’
0.5 ml
0. 1 ml
1.0 ml
0. 2 ml
1 ml
0. 5 ml
49 ml
1. 0 ml
100 kg
ħut li se jiġi konċentrat Volum ta ’ solvent injettat 50 kg 100 kg
The diluted solution for injection should be used immediately.
Is- soluzzjoni għall- injezzjoni dilwita għanda tiġi użata immedjatament.
WITHDRAWAL PERIOD
Perjodu ta ’ Tiżmim
Keep out of the reach and sight of children.
Żomm fejn ma jintlahaqx u ma jidhirx mit- tfal.
Do not freeze.
Aħżen u ttrasporta f' temperatura ta ’ 2°Ċ – 8°Ċ (fil- friġġ).
Do not use after the expiry date stated on the label.
Tiffriżax Tużax wara d- data tal- iskadenza fuq it- tikketta.
After first opening the container, the solvent may be stored for 28 days.
Meta tiftaħ is- solvent, dan tista ’ taħżnu għal 28 ġurnata.
After dilution, the product should be used immediately.
Wara li tħallat, uża l- prodott mill- ewwel
SPECIAL WARNING(S)
PREKAWZJONIJIET SPEĊJALI
Operators should wear gloves when mixing the concentrate solution with the solvent.
Tħallatx ma prodotti mediċinali oħra Ilbes l- ingwanti meta tħallat il- konċentrat mas- solvent
Medical advice should be sought immediately in cases in which the concentrated solution or several ml of the
F' każ ta ’ li xxerred il- konċentrat jew ftit mis- soluzzjoni fuq il- ġilda jew f’ għajnejk, jew f’ kas li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ nformazzjoni li jkun fih ġewwa.
31/ 37 diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection.
31/ 37 Aħsel idejk wara li tuża l- prodott.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAL RIMI TA ’ MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEĦOR, JEKK IKUN IL- KAŻ
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META GIE RIVEDUT L- AĦĦAR IL- FULJETT INFORMATTIV.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljat fuq dan il- prodott mediċinali veterinarju jinsab fuq il- website ta ’ l- Aġenzija Ewropeja tal- Mediċini (EMEA) http: // www. emea. europa. eu
None.
-
32/ 37 PACKAGE LEAFLET Gonazon 18.5 mg implant for dogs
32/ 37 FULJETT TA ’ TAGĦRIF Gonazon 18. 5 mg impjant għall- klieb
Marketing authorisation holder:
IS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
Manufacturer responsible for the batch release:
IS- SID TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ
Intervet GesmbH Siemensstraβ e 107 A-1210 Wien Austria
Intervet GesmbH Siemenssreabe 107 A- 1210 Wien Awstrija
Gonazon 18.5 mg implant for dogs
Gonazon, 18. 5mg impjant għall- klieb
Azagly-nafarelin 18.5 mg
Azagly – nafarelin 18. 5 mg
CONTRAINDICATIONS
Kontra indikazzjonijiet
Do not use in bitches (prepubertal and adult) intended for breeding.
Tuzax fi klieb tas- sess femminili (qabel il- puberta` u adulti) li huma intenzjonati għat- tgħamir (ara sezzjoni 4. 7).
ADVERSE REACTIONS
Effetti mhux mixtieqa (frekwenza u gravità)
Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis.
Minħabba l- attivita farmakoloġika (inħibizzjoni tal- produzzjoni tal- ormoni tas - sess), l - amministrazjoni tal- agonisti GnRH jistgħu jiġu assoċjati ma vaġinitis.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effet serju nhux mixtieq jew xi effet ieħor mhux imsemmi f’ dan il- fuljett informattiv, jekk jogħġbok informa lit- tabib veterinarju.
Dog (bitches).
Klieb (tas- sess femminili)
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Doża rakkomandata u l- metodu ta 'amministrazzjoni
For subcutaneous administration.
Għall- taħt il- ġilda.
In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of giant breeds over 45 kg bodyweight.
Fin- nuqqas ta’ informazzjoni klinika, titrattax kelbat ta’ anqas mit- 3 kg piż ħaj u kelbat ta ’ razzez kbar li jaqbżu l- 45 kg piż ħaj.
The implant may be administered to bitches from the age of four months.
L- impjant jista jiġi amministrat lil kelbiet li għandhom minn erba ’ xhur żmien.
In adult bitches, the first treatment should be administered preferably in metoestrus.
L- ewwel trattament f’ kelbiet adulti għandu jingħata f’ metoestrus.
The duration of prevention of gonadal function is obtained as detailed in the table below:
Iż- żmien li l- funzjoni tal- gonadi tiġi mwaqqfa hija kif murhija fit- tabella hawn taħt:
Age at which treatment is started
Eta` meta beda t- trattament
In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus.
Fil- kelbiet li l- funzjoni tal- gonadi ġie mwaqqaf b’ suċċess għal perjodu ta ’ 12- il xahar, jista jingħata t - tieni trattament f’ dak il- ħin biex ikompli jiġi inibit l- estru.
ADVICE ON CORRECT ADMINISTRATION
PARIR FUQ AMMINISTRAZZJONI KORRETTA
Using aseptic technique, raise a small piece of skin in the region of the dog’ s umbilicus.
B’ metodu assettiku, għolli ftit ġilda fin- naħa taż- żokkra tal- kelb.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion (Fig.
Daħħal il- labbra taħt il - ġilda, b’ angolu ta’ 30 grad fil- ġilda mgħollija f’ moviment wieħed.
With your free hand, use the thumb grip to hold the injection device in position, and depress the plunger as far as it can go.
Bl- id il- ħielsa, żomm l- instrument tal- injezzjoni fil- pożizzjoni billi tuża s- sebgħa l- kbir, għafas l- plunger l- aktar l- isfel li jista` jinżel.
This retracts the needle and withdraws it, leaving the implant beneath the skin (Fig.
B’ hekk il- labbra tinġibed u tħalli l- impjant taħt il- ġilda.
34/ 37
34/ 37 Fig. 1
REMOVAL:
TNEĦĦIJA:
Chemical restraint (sedation and/ or general anaesthesia) may be required for implant removal.
Jista jkun hemm bżonn jiġi ristrett kimikament (sedat jew/ u anestesija ġenerali).
Position the dog as described for administration of the implant.
Poġġi l- kelb kif imfiehem għal amministrazzjoni tal- impjant.
Locate the implant by gentle digital palpation of the administration site.
Illokalizza l- impjant billi delikatament tipressa bis- swaba l- post tal- amministrazjoni.
After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the implant.
Wara li jingħata biżżejjed loppju (lokali), agħafas bil- mod bis- swaba naħa waħda ta l - impjant.
Push the implant gently towards the stab incision.
Imbotta l- impjant bil- mod in- naħa ta ’ fejn hemm il- qasma.