qanastek/EMEA-V3 huggingface dataset:
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi injettat bi żball b' dan il- prodott, fittex għajnuna medika mill- ewwel, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'nformazzjoni miegħek.
To the physician:
18/ 21 Għat- Tabib:
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPECJALI DWAR RIMI TA ’ PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Any unused product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Kull prodott mediċinali veterinarju li ma ġiex użat jew materjal ieħor derivat minn dawk il- prodotti mediċinali veterinarji għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
10 x 1 ml presentation:
Preżentazzjoni ta ’ 10 x 1 ml:
20 x 1 ml presentation:
Kaxxa li fiha 10 siringi mimlijin bil- lest ta ’ doża waħda u 10 labar sterili Preżentazzjoni ta ’ 20 x 1 ml:
25 x 1 ml presentation:
Kaxxa li fiha 20 siringi mimlijin bil- lest ta ’ doża waħda u 20 labar sterili Preżentazzjoni ta ’ 25 x 1 ml:
Box containing 25 single dose prefilled syringes and 25 sterile needles.
Kaxxa li fiha 25 siringi mimlijin bil- lest ta ’ doża waħda u 25 labar sterili
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal iktar tagħrif fuq dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- awtorizzazzjoni tal- kummerċ.
17/ 19 België/ Belgique/ Belgien Fort Dodge Animal Health Benelux B. V.
19/ 21 België/ Belgique/ Belgien Fort Dodge Animal Health Benelux B. V.
Allemagne/ Deutschland Tel:
Luxemburg/ Luxembourg Fort Dodge Animal Health Benelux B. V. Allemagne/ Deutschland Tel:
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta ’ Valutazzjoni.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar - rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Flexicam?
X’ inhu Flexicam?
Flexicam contains meloxicam which belongs to a class of medicines having anti- inflammatory action.
Flexicam fih meloxicam li jappartjeni għal klassi ta ’ mediċini li jaġixxu kontra l - infjammazzjonijiet.
Flexicam is presented as a pale green oral suspension (1.5mg/ ml) for dogs (to be given mixed with food) and a yellow solution for injection (5mg/ ml) for dogs and cats.
Flexicam huwa disponibbli f’ sospensjoni orali ta ’ lewn aħdar ċar (1. 5 mg/ ml) għall- klieb (li għandu jingħata mħallat mal- ikel) u soluzzjoni injettabbli safra (5 mg/ ml) għall- klieb u l- qtates.
Flexicam is a ‘ generic’: this means that Flexicam is similar to a ‘ reference veterinary medicine ’ already authorised in the EU (Metacam 1.5 mg/ ml oral suspension).
Flexicam huwa ‘ mediċina ġenerika ’: dan ifisser li Flexicam huwa simili għal ‘ mediċina veterinarja ta ’ referenza ’ li hija diġà awtorizzata fl- UE (Metacam 1. 5 mg/ ml sospensjoni orali).
Studies have been carried out to prove that Flexicam is ‘ bioequivalent ’ to the reference veterinary medicine: this means that Flexicam is equivalent to Metacam 1.5 mg/ ml suspension in the way it is absorbed and used by the body.
Twettqu studji sabiex juru li Flexicam huwa ‘ bijoekwivalenti ’ għall- mediċina veterinarja ta ’ referenza: dan ifisser li Flexicam huwa ekwivalenti għal Metacam 1. 5 mg/ ml sospensjoni fil - mod ta ’ kif jiġi assorbit u użat mill- ġisem.
What is Flexicam used for?
Għal xiex jintuża Flexicam?
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Klieb: għas- serħan mill- infjammazzjoni u wġigħ f’ disturbi muskoluskeletriċi kemm akuti kif ukoll kroniċi u għat- tnaqqis tal- uġigħ postoperatorju u l- infjammazzjoni wara interventi kirurġiċi ortopediċi u tat- tessuti rotob.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Qtates: għat- tnaqqis tal- uġigħ postoperatorju wara ovarjoisterektomija u interventi minuri fuq it- tessuti rotob.
How does Flexicam work?
Kif jaħdem Flexicam?
Flexicam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Flexicam fih meloxicam li jappartjeni għal klassi ta ’ mediċini msejħin mediċini antinfjammatorji mhux sterojdali (NSAIDs).
As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Minħabba li l- prostaglandini huma sustanzi li jikkawżaw l- infjammazzjoni, l - uġigħ, il- ħruġ ta ’ għaraq u d- deni, meloxicam inaqqas dawn ir- reazzjonijiet.
How has Flexicam been studied?
Kif ġie studjat Flexicam?
Flexicam has been investigated in comparison with Metacam which is already authorised in the EU.
Flexicam ġie eżaminat billi tqabbel ma ’ Metacam li huwa diġà awtorizzat fl- UE.
A study looked at how Flexicam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5mg/ ml.
Sar studju li eżamina kif Flexicam jiġi assorbit u l- effetti tiegħu fil- ġisem, meta mqabbla ma ’ Metacam sospensjoni orali 1. 5 mg/ ml.
What benefit has Flexicam shown during the studies?
Liema benefiċċju wera Flexicam waqt l- istudji mwettqa?
Flexicam is efficacious in alleviating the inflammation and pain in both acute and chronic musculo-skeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats.
Flexicam huwa effikaċi fis- serħan tal- infjammazzjoni u tal- uġigħ f’ disturbi muskoluskeletriċi kemm akuti kif ukoll kroniċi u fit- tnaqqis tal- uġigħ postoperatorju wara interventi kirurġiċi ortopediċi u tat- tessuti rotob fil- klieb u fit- tnaqqis tal- uġigħ postoperatorju wara ovarjoisterektomija u interventi minuri fuq it- tessuti rotob fil- qtates.
What is the risk associated with Flexicam?
X’ inhu r- riskju assoċjat ma ’ Flexicam?
Occasional side effects of Flexicam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Bi Flexicam ġew osservati okkażjonalment effetti sekondarji tipiċi tal- NSAIDs, bħal telf tal - aptit, remettar, dijarrea, demm fil- feċi u apatija (nuqqas ta ’ vitalità).
They disappear once treatment has stopped.
Huma jgħibu ladarba jitwaqqaf it- trattament.
In very rare cases, they may be serious or fatal.
F’ każijiet verament rari, jistgħu jkunu gravi jew fatali.
Flexicam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases.
Flexicam m’ għandux jingħata lil annimali ħobla jew li qed ireddgħu minħabba li s- sigurtà tal - prodotti ma ġietx stabbilita f’ dawn il- każijiet.
Flexicam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Barra minn hekk Flexicam m’ għandux jintuża f’ annimali li jsofru minn disturbi gastrointestinali jew emorraġiċi u b’ indeboliment tal - funzjoni renali jew epatika, f’ annimali b’ ipersensittività magħrufa għall- NSAIDs u f’ annimali ta ’ età inqas minn 6 ġimgħat jew fi qtates li jiżnu inqas minn 2 kg.
An oral follow-up therapy using meloxicam or other NSAIDs should not be used in cats, as no safe dosage for repeated oral administration has been established.
L- ebda terapija orali ta ’ segwitu m’ għandha tingħata lil qtates bl- użu ta ’ meloxicam jew NSAIDs oħra, billi ma ġiex stabbilit dożaġġ sikur għat- teħid orali ripetut.
People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
Il- persuni b’ ipersensittività magħrufa (allerġija) għal meloxicam għandhom jevitaw kuntatt mal- prodott.
Accidental self-injection may give rise to pain.
L- awtoinjezzjoni aċċidentali tista ’ tikkawża wġigħ.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
F’ każ li l- prodott jinbela ’ minn persuna, din għandha tkellem minnufih lil tabib.
In case of accidental self-injection, medical advice should be sought immediately showing the package leaflet or the label to the physician.
Fil- każ ta ’ awtoinjezzjoni aċċidentali, kellem minnufih lil tabib billi turih il- fuljett ta ’ tagħrif jew it- tikketta.
Why has Flexicam been approved?
Għaliex ġie approvat Flexicam?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Flexicam has been shown to be bioequivalent to Metacam 1.5 mg/ ml oral suspension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkunsidra li, skont ir - rekwiżiti tal- Unjoni Ewropea, Flexicam wera ruħu bijoekwivalenti għal Metacam 1. 5 mg/ ml sospensjoni orali.
The CVMP concluded that the benefits of Flexicam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Flexicam be given a marketing authorisation.
Is- CVMP ikkonkluda li l- benefiċċji ta ’ Flexicam huma akbar mir- riskji fis - serħan tal- infjammazzjoni u tal- uġigħ f’ disturbi muskoluskeletriċi kemm akuti kif ukoll kroniċi u fit- tnaqqis tal- uġigħ postoperatorju u infjammazzjoni wara interventi kirurġiċi ortopediċi u tat- tessuti rotob fil- klieb u fit- tnaqqis tal- uġigħ postoperatorju wara ovarjoisterektomija u interventi minuri fuq it- tessuti rotob fil- qtates u rrakkomanda li Flexicam jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji jista ’ jiġi kkonsultat fil- modulu 6 ta ’ dan l- EPAR.
Other information about Flexicam:
Aktar tagħrif dwar Flexicam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Flexicam to Omnipharm Ltd. on 10 April 2006 and an extension to Flexicam 5mg/ ml solution for injection on 9 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Flexicam lil Omnipharm Ltd. fl- 10 ta ’ April 2006 u estensjoni għal Flexicam 5 mg/ ml soluzzjoni injettabbli fid- 9 ta ’ Diċembru 2008.
Target species
Speċi li fuqhom grandu jintuża lprodott
1
1 Flexicam 1, 5 mg/ ml
dogs
Klieb
oral
Orali
1
Flixkun talpoli - 10 ml 1 Etilin
32 ml 1
Flixkun talpoli - 32 ml 1 Etilin
100 ml 1
Flixkun talpoli - 100 ml 1 Etilin
EU/ 2/ 06/ 058/ 004
EU/ 2/ 06/ 058/ 004 Flexicam 5 mg/ ml
solution for injection
Soluzzjoni għall- injezzjoni
dogs and sc/ iv cats
Klieb u Qtates
Glass vial
Injezzjoni Kunjett ta ’ taħt ilġilda linjezzjoni jew ġol- vini (ħġieġ)
Flexicam 1.5 mg/ ml oral suspension for dogs
Flexicam 1. 5 mg/ ml Suspensjoni orali għall- klieb
1.5 mg
Kull ml ta ’ Flexicam 1. 5 mg/ ml suspensjoni orali fih:
Oral suspension Flexicam is a pale green, uniform suspension containing 1.5 mg/ ml meloxicam
Suspensjoni orali.
CLINICAL PARTICULARS:
TAGĦRIF KLINIKU
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product.
Tużax f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Prekawzjonijiet speċjali għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
2/ 34 Special precautions to be taken by the person administering the veterinary medicinal product product to animals
2/ 30 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Flexicam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
The suspension can be given using either the drop dispenser (for very small breeds) or the Flexicam measuring syringe provided in the package.
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Flexicam tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ mard kroniku muskolu- skeletriku, jista ’ jvarja matul iż- żmien.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
3/ 34 4.11 Withdrawal periods
4. 11 Perjodu( i) ta ’ tiżmim
Dispersible cellulose Xanthan gum Sodium benzoate Glycerol Xylitol Sodium lauryl sulphate Citric acid monohydrate Sodium citrate Honey flavour
- Sodium dihydrogen phosphate dihydrate
4/ 34 Simethicone emulsion Purified water
- Silica, colloidal anhydrous
Flexicam 5 mg/ ml solution for injection for dogs and cats.
Flexicam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Each ml of Flexicam 5 mg/ ml solution for injection contains:
Kull ml ta ’ Flexicam 5 mg/ ml soluzzjoni għall- injezzjoni fih:
Flexicam 1.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Flexicam 1. 5 mg/ ml suspensjoni orali għall- klieb jista ’ jintuża għat- tkomplija tat- trattament f’ dożaġġ ta ’ 0. 1 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l- injezzjoni.
5.2 Pharmacokinetic particulars
5. 2 Tagħrif farmakokinetiku
Absorption Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ ml in dogs and 1.1 µg/ ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Assorbiment Wara l- għoti taħt il- ġilda, meloxicam hu kompletament bijodisponibbli, u l- ogħla medja ta ’ konċentrazzjonijiet fil- plażma ta ’ 0. 73 µg/ ml, fil- klieb u 1. 1 µg/ ml fil- qtates intlaħqu wara madwar 2. 5 sigħat u 1. 5 sigħat wara l- għoti rispettivament.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Distribuzzjoni Hemm relazzjoni lineari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad - doża terapewtika fil- klieb.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
Flexicam 1.5 mg/ ml oral suspension for dogs
Flexicam 1. 5 mg/ ml suspensjoni orali għall- klieb Meloxicam
SPECIAL WARNING(S), IF NECESSARY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Read the package insert before use
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
18/ 34 10.
16/ 30 10.
19/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
100 ml
Użu orali.
MANUFACTURER’ S BATCH NUMBER
Għal trattament ta ’ l- annimali biss.
21/ 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18/ 30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Meloxicam.
Flexicam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates Meloxicam
Read the package leaflet before use.
Tużax fuq annimali tqal jew li qed ireddgħu.
Once broached use by
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Do not store above 25 °C
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UZU, jekk applikabbli
Dispose of in accordance with local requirements.
Għal trattament ta ’ l- annimali biss.
For animal treatment only - to be supplied only on veterinary prescription.
Għandu jingħata biss bi preskrizzjoni veterinarja.
Batch{number}
Lot {numru}
23/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20/ 30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
Flexicam 1.5 mg/ ml oral suspension for dogs
Flexicam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates Meloxicam
NAME OF THE VETERINARY MEDICINAL PRODUCT
SPEĊJI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
Meloxicam
Klieb u qtates
Avoid introduction of contamination during use.
Klieb: jingħata ġol- vina jew taħt il- ġilda Qtates: jingħata taħt il- ġilda
25/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
FULJETT TA ’ TAGĦRIF FIL- PAKKETT
100 ml bottle
Flexicam 1. 5 mg/ ml suspensjoni orali għall- klieb
1.5 mg/ ml
Flexicam 1. 5 mg/ ml Suspensjoni orali għall- klieb Meloxicam
100 ml
Meloxicam 1. 5 mg/ ml (ekwivalenti għal 0. 05 mg kull qatra)
BATCH NUMBER
Tużax fuq klieb li għandhom inqas minn 6 ġimgħat.
Batch {number}
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
28 days
SPEĊI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
8.
Klieb
27/ 34 B.
23/ 30 8.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA ’ AMMINISTRAZZJONI
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dożaġġ It- trattament tal- bidu tikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum.
STATEMENT OF THE ACTIVE SUBTANCES AND OTHER INGREDIENTS
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid - doża tal- manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
Meloxicam
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Flexicam tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ mard kroniku muskolu- skeletriku, jista ’ jvarja matul iż- żmien.
1.5mg/ ml
Mod ta ’ kif u mnejn jingħata
(equivalent to 0.05 mg per drop)
Ħawwad tajjeb qabel l- użu.
INDICATION(S)
4 qtar / kg ta ’ piż tal- ġisem Doża tal- manteniment:
CONTRAINDICATIONS
2 qatriet / kg ta ’ piż tal- ġisem
Do not use in pregnant or lactating animals.
Il- proċedura tad- dożaġġ bl- użu tas- siringa tal- kejl:
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product.
Is- siringa teħel mal- qattara tal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi mad- doża tal- manteniment.
Do not use in dogs less than 6 weeks of age.
Għalhekk, għall- bidu tat- terapija fl- ewwel jum, id- doppju tal- volum tal - manteniment ser ikun meħtieġ.
ADVERSE REACTIONS
Ħawwad il- flixkun sew.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Aqleb il- flixkun/ is- siringa ta ’ taħt fuq.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Iġbed il- planġer ’ il barra sakemm is- sinjal iswed fuq il- planġer ikun jikkorrispondi mal- piż tal - ġisem tal- kelb tiegħek f’ kilogrammi.
If you notice any other side effects, please inform your veterinary surgeon.
Dawwar il- flixkun lura kif suppost u permezz ta ’ moviment li jilwi, issepara s - siringa tad- dożaġġ minn mal - flixkun.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Imbotta l- planġer ’ l isfel u battal il- kontenut tas- siringa fuq l- ikel jew direttament ġol - ħalq.
Treatment is to be continued once daily by oral administration (at 24- hour intervals) at a maintenance dose of 0.1 mg meloxicam/ kg body weight.
Alternattivament, it- terapija tista ’ tinbeda b’ 5 mg/ ml soluzzjoni għal injezzjoni ta ’ Flexicam.
A clinical response is normally seen within 3- 4 days.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 10 ijiem, l- ebda titjib kliniku ma jkun evidenti.
Please carefully follow the instructions of the veterinarian.
Jekk jogħġbok segwi bl - attenzjoni l- istruzzjonijiet tal- veterinarju.
Shelf- life of opened bottle:
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
9 months.
9 xhur.
Do not use after expiry date stated on the carton and the bottle.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Prekawzjonijiet għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
Flexicam must not be administered in conjunction with other NSAIDS or glucocorticosteroids.
Flexicam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
In the case of overdosage symptomatic treatment should be initiated.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
People with known hypersensitivity to NSAIDS should avoid contact with the veterinary medicinal product.
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
In case of accidental ingestion, seek medical advice immediately and show this package insert or the label to the physician.
Staqsi lil veterinarju tiegħek dwar kif l- aħjar li tarmi l- mediċini li ma jkunux aktar meħtieġa minnek.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT FIL- PAKKETT
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED
TAGĦRIF IEĦOR
10.04.2006
Flixkun ta ’ 10, 32 jew 100 ml.
31/ 34 PACKAGE LEAFLET Flexicam 5 mg/ ml solution for injection for dogs and cats
Flexicam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Flexicam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
For post-operative pain relief in cats, safety has only been documented after thiopental/ halothane anaesthesia.
F’ annimali li jkunu f’ riskju tal- loppju (eż. annimali xjuħ), it- terapija bil- fluwidu ġol- vina jew taħt il- ġilda waqt il- loppju għandha tigi kkunsidrata.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Meta l - loppju u NSAID jingħataw flimkien, ma jistax jiġi eskluż li jista ’ jkun hemm riskju għall- funzjoni tal - kliewi.
User warnings
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma jibda t- trattament Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Biex itaffi l- uġigħ ta ’ wara l- operazzjoni, is- sigurtà kienet dokumentata biss wara loppju b’ thiopental/ halothane.
14.
29/ 30 14.
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 magħmula mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet għall- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk trid iktar informazzjoni dwar il- kundizzjoni medika jew dwar it- trattament ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid iktar informazzjoni fuq il- bażi tar- rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Gonazon?
X’ inhu Gonazon?
Gonazon contains the active substance azagly-nafarelin.
Gonazon fih is- sustanza attiva azagly- nafarelin.
Gonazon is authorised as a concentrate that is made into a solution for injection for salmonid fish and also as an implant for dogs.
Gonazon hu awtorizzat bħala konċentrat li jinħall f’ soluzzjoni għall- injezzjoni għall- ħut salmonid u wkoll bħala impjant għall- klieb.
Gonazon implant is rectangular in shape, off white, with dimensions of 14x3x1 mm.
14x3x1 mm.
What is Gonazon used for?
Għal x’ hiex jintuża Gonazon?
In fish, Gonazon is used to induce and synchronise ovulation (egg production) in female salmonids such as Atlantic salmon, rainbow trout, brown trout and Arctic charr for the production of eyed-eggs and fry.
Fil- ħut, Gonazon jintuża biex jinduċi u jissinkronizza l- ovulazzjoni (il- produzzjoni tal- bajd) u fis - salmodids femminili, bħas- Salamun ta ’ l- Atlantiku, it- trota bi lwien il- qawsalla, it- trota kannella u ċ - charr Arktiku għall- produzzjoni ta ’ bajdiet bil- għajn u ħut żgħir.
Following anaesthesia, the fish are injected intraperitoneally (into the area that contains the abdominal organs) along the central line, 1/ 2 to 1 fin length in front of the pelvic fin base.
Wara l- anestesija, il- ħut jiġi injettat fil- peritonew (fil- wisgħa li jkun fiha l- organi addominali) ma ’ tul linja ċentrali, bejn nofs tul u tul ’ il quddiem mill- bażi tal- garġi pelviku.
The recommended dose is 32 µg/ kg bodyweight.
Id- doża rrakkomandata hi 32 µg għal kull kilo toqol.
In bitches, Gonazon is also indicated for the prevention of gonadal function via long term blockade of gonadotrophin synthesis.
Fil- klieb nisa, Gonazon hu indikat fil- prevenzjoni tal- funzjoni gonadali permezz ta ’ imblokk fit- tul tas- sintesi tal- gonadotrophin.
Gonazon is injected subcutaneously, in the region of the umbilicus.
Gonazon jiġi injettat taħt il- ġilda, fir- reġjun taż- żokra.
The implant may be administered to bitches from the age of four months (blocking reproductive function for an average of 12 months) to 6 years (blocking reproductive function for an average of 11 months).
L- impjant jista ’ jiġi amministrat fil- klieb nisa mill- età ta ’ erba ’ xhur (u dan jimblokka l- funzjoni riproduttiva għal medja ta ’ 12- il xahar) sa sitt snin (bl- imblokk tal- funzjoni riproduttiva għal medja ta ’ 11- il xahar).
How does Gonazon work?
Kif jaħdem Gonazon?
Gonazon contains azagly-nafarelin, which is an analogue of a natural hormone called gonadotrophin- releasing hormone (GnRH).
Gonazon fih azagly- nafarelin, li hu analogu ta ’ ormon naturali magħruf bħala gonadotrophin - releasing hormone (GnRH).
GnRH controls reproduction in fish by increasing the secretion of the gonadotrophins controlling egg production.
Il- GnRH jikkontrolla r- riproduzzjoni tal- ħut billi jżid is- sekrezzjoni tal - gonadotrophins li jikkontrollaw il- produzzjoni tal- bajd.
In dogs, administration of higher doses of GnRH agonists over a period of time desensitises the pituitary gland with the result that release of gonadotrophins is suppressed, leading to a suppression of reproductive function.
Fil- klieb nisa, l- amministrazzjoni ta ’ dożi ogħla ta ’ l- agonisti tal- GnRH matul ċertu żmien jiddesentisizza l- pituitary gland u b’ hekk il- ħruġ tal- gonadotrophins tiġi mrażżna, u dan iwassal għal sopressjoni tal- funzjoni riproduttiva.
How has Gonazon been studied?
Kif ġie studjat Gonazon?
In fish, Gonazon has been studied in three studies of rainbow trout, two studies of Altlantic salmon, and one study of Arctic charr.
Fil- ħut, Gonazon ġie studjat fi tliet studji tat- trota bi lwien il- qawsalla, żewġ studji tas- salamun ta ’ l - Atlantiku, u studju wieħed taċ- charr Arktiku.
The main measure of effectiveness was the speed of response to treatment and the advance in time and synchronisation of the spawning period.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien il- ħeffa tar - rispons għat- trattament u l- avvanz fil- ħin u fis- sinkronizzazzjoni tal- perjodu tal- bidien tal- bajd.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 In bitches, the results of two field studies with Gonazon implants were provided, one investigating a single administration, another one the repeated application over a second year.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 Fil- klieb nisa, ġew pprovduti r- riżultati ta ’ żewġ studji li saru fuq il- post b’ impjanti Gonazon; wieħed minnhom stħarreġ l- amministrazzjoni ta ’ darba, u l- ieħor stħarreġ l- applikazzjoni ripetuta matul it - tieni sena.
Bitches treated with Gonazon generally failed to display heat during the study compared to bitches who did not receive the treatment.
Il- klieb nisa ttrattati b’ Gonazon ġeneralment ma dehrux li kellhom saħna meta mqabbla ma ’ klieb nisa li ma kinux ħadu t- trattament.
Good efficacy has been demonstrated for the prevention of heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment.
It- trattament instab effettiv fil- prevenzjoni tas- saħna u l - ovulazzjoni f’ kelbiet nisa adulti li ma kellhomx iktar minn seba ’ snin matul is- sena jew sentejn ta ’ trattament.
Data on the return to oestrus, ovulatory oestrus and subsequent fertility once treatment has ended (i. e. once the implant had been removed) were limited, especially for repeated treatment.
It- tagħrif dwar ir- ritorn għan- normal ta ’ l- utru, ta ’ l- utru ovulatorju u tal- fertilità sussegwenti ladarba t- trattament ikun twaqqaf (jiġifieri ladarba jkun tneħħa l- impjant) kienet limitata, speċjalment għal trattament ripetut.
What benefit has Gonazon shown during the studies?
X’ inhu l- benefiċċju ta ’ Gonazon li ntwera f’ dawn l- istudji?
In fish, the results of the trials showed that Gonazon was effective to induce and synchronise ovulation.
Fil- ħut, ir- riżultati ta ’ l- istudji wrew li Gonazon kien effettiv biex jinduċi u jissinkronizza l - ovulazzjoni.
In most cases, an effect was induced within 6-11 days of treatment, and ovulation was generally advanced by 2-3 weeks.
F’ ħafna mill- każijiet, l- effett kien indott fi żmien 6 u 11- il jum mill- bidu tat- trattament, u l- ovulazzjoni ġeneralment kienet avvanzata b’ bejn ġimagħtejn u tliet ġimgħat.
The use of Gonazon while not necessarily improving reproductive performance over the course of the spawning season, by synchronising spawning will shorten the time span dedicated to eyed egg production.
L- użu ta ’ Gonazon, għalkemm ma kienx neċessarjament qed itejjeb il- prestazzjoni fir- riproduzzjoni matul l- istaġun tal - bidien, kien madanakollu qed inaqqas il- ħin dedikat għall- produzzjoni ta ’ bajd bil- għajn billi jissinkronizza l- bidien tal- bajd.
This optimises organisation of the fish farm.
Dan jottimizza l- organizzazzjoni tar- razzett tal- ħut.
In bitches, it has been demonstrated that the insertion of a Gonazon implant will prevent heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment.
Fil- klieb nisa, intwera li l- infilzar ta ’ impjant ta ’ Gonazon jipprevjeni s- saħna u l- ovulazzjoni fi klieb nisa adulti li ma jkollhomx iktar minn 7 snin waqt it- trattament ta ’ sena jew sentejn.
What is the risk associated with Gonazon?
X’ inhu r- riskju assoċjat ma ’ Gonazon?
In fish, the injection of Gonazon may be associated with a reduction in fecundity (ability to breed), egg quality and survival to the eyed-egg stage.
Fil- ħut, l- injezzjoni ta ’ Gonazon tista ’ tkun assoċjata ma ’ tnaqqis fil- fertilità (kapaċità tat- tnissil), fil - kwalità tal- bajd u fis- sopravivenza fl- istadju tal- bajd bil- għajn.
In some cases this can be caused by use of Gonazon too early in the spawning season.
F’ xi każijiet dan jista ’ jiġi kkawżat mill- użu wisq bikri ta ’ Gonazon fl- istaġun tal- bidien tal- bajd.
In bitches, Gonazon works by inhibition of the production of sex steroids and may be associated with rare cases of vaginitis in prepubertal females.
Fil- klieb nisa, Gonazon jaħdem billi jinibixxi l- produzzjoni ta ’ l- isterojdi sesswali, u jista ’ jkun assoċjat ma ’ każi rari ta ’ vaġinite fil- klieb nisa ta ’ qabel il- pubertà.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li trid tieħu l- persuna li tagħti l- mediċina jew li jkollha kuntatt ma ’ l- annimal?
Operators should wear gloves when mixing the concentrate solution or handling the implant and avoid self injection.
L- operaturi għandhom jilbsu ingwanti meta jħalltu s- soluzzjoni tal- konċentrat jew meta jmissu l - impjant u jevitaw li jinjettaw lilhom infushom.
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water.
Fil- każ ta ’ kuntatt aċċidentali mal- ġilda jew ma ’ l- għajnejn, laħlaħ sew bl- ilma.
If the concentrated solution or the diluted solution is spilled onto the skin or into the eyes, or the implant is accidentally self-injected, medical advice should be sought immediately.
Jekk is- soluzzjoni konċentrata jew is- soluzzjoni dilwita tinxtered fuq il- ġilda jew fl- għajnejn, jew l- operatur bi żball jinjetta l- impjant lilu nniffsu, wieħed għandu jfittex parir mediku immedjatatment.
The package leaflet or the label should be shown to the doctor.
Il- fuljett ta ’ tagħrif jew it- tikketta tal- prodott għandhom jintwerew lit- tabib.
Operators should wash their hands after use of the product.
L- operaturi għandhom jaħslu jdejhom wara li jużaw il- prodott.
Why has Gonazon been approved?
Għaliex ġie approvat Gonazon?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Gonazon are greater than any risks for the induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Il- Kumitat għall- Prodotti Mediċinali għal użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Gonazon u s- sinkronizzazzjoni ta ’ l- ovulazzjoni għall- produzzjoni ta ’ bajd bil- għajn u ħut żgħir huma ikbar mir - riskji tiegħu.
Gonazon implants are effective in prevention of gonadal function via long term blockade of gonadotrophin synthesis.
L- impjanti ta ’ Gonazon huma effettivi fil- prevenzjoni tal- funzjoni gonadali permezz ta ’ l- imblukkar tas- sinteżi tal- gonadotrophin.
The CVMP recommended that Gonazon should be given a marketing authorisation.
Il- CVMP irrrakkomanda li Gonazon ikun jista ’ jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn ir- riskju u l- benefiċċju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Gonazon:
Tagħrif ieħor dwar Gonazon:
The European Commission granted a marketing authorisation valid throughout the European Union, for Gonazon to Intervet International BV on 22 July 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Gonazon valida fl- Unjoni Ewropea kollha lil Intervet International BV fit- 22 ta ’ Lulju 2003.
Gonazon implants were authorised by an extension application, granted by the European Commission in January 2007.
L- impjanti ta ’ Gonazon ġew awtorizzati b’ applikazzjoni ta ’ estensjoni, mogħtija mill- Kummissjoni Ewropea f’ Jannar 2007.
Information on the prescription status of this product may be found on the labelling.
Tagħrif dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta.
This summary was last updated in December 2006.
Dan is- sommarju ġie aġġornat l- aħħar f '12- 2006.
Invented Strength name
Invented Strength name
Pharmaceutical form
Pharmaceutical Form
Target species
Target species
Withdrawal period
Withdrawal period
1,600 microgram/ ml
1, 600 microgram/ ml
concentrate and solvent for solution for injection
concentrate and solvent for solution for injection
Female salmonid fish
Female salmonid fish
Intraperitoneal injection
Intraperitoneal injection
Concentrate: vial (glass) Solvent: vial (glass) Sterile empty vial:
Concentrate: vial (glass) Solvent: vial (glass) Sterile empty vial:
Concentrate:
Concentrate:
2 ml 1 vial Solvent:
2 ml 1 vial Solvent:
100 ml concentrate 1 vial solvent 1 sterile empty vial
100 ml concentrate 1 vial solvent 1 sterile empty vial
Zero days
Zero days
EU/ 2/ 03/ 040/ 002 Gonazon 18.5 mg
EU/ 2/ 03/ 040/ 002 Gonazon 18. 5 mg
Dogs
Dogs
Subcutaneous
Subcutaneous
Preloaded injection device, (hypodermic needle covered with a protective cap)
device, (hypodermic needle covered with a protective cap)
1 pre-loaded injection device
1 pre- loaded injection device
Not applicable
Not applicable
Gonazon concentrate for solution for injection of female salmonid fish
Soluzzjoni konċentrata għall- injezzjoni fl- ispeċi femminili tas- salamun
VIAL CONTAINING CONCENTRATE:
Kunjett li fih dan il- konċentrat:
Active substance(s)
Sustanzi Attiv/ i:
Azagly-nafarelin 1600 µg/ ml as azagly-nafarelin acetate.
Azagly – nafarelin 1600 mikrogramma / ml bhala azagly – nafarelin acetate
Excipients
Eċċipjent:
VIAL CONTAINING SOLVENT:
Kunjett tas- solvent:
Benzyl alcohol (1%)
Eċċipjent Benzyl alcohol (1%)
For a full list of excipients, see section 6.1.
Għall- lista sħiħa ta ’ eċċipjenti, ara sezzjoni 6. 1
Concentrate for solution for injection
Konċentrat intenzjonat għal soluzzjoni għall- injezzjoni.
4.1 Target species
4. 1 Speċi li l- prodott għandu jintuża fuqhom
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 Atlantiku (Salmo solar), Troti tal- Qawsalla (Oncorhynchus mykiss), trota kannella (Salmo trutta) u t- trota l- ħamra (Salvelinus alpinus).
4.2 Indications for use, specifying the target species
4. 2 Indikazzjoni għall - użu tal- Prodott (semmi l- ispeċi li għandu jintuża fuqhom il- prodott) jekk ikun il- każ.
Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Induzzjoni u sinkronizzazzjoni ta ’ l - ovulazzjoni għall- produzzjoni tal- bajd u l- friegħ tal- ħut.
Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally.
Tużax Gonazon qabel madwar 10% tal- ħut ikun ovula b’ mod naturali.
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.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin.
Tnaqqis fil- fertilita ’, kwalita ’ u sopravivenza tal- bajd ġiet osservata f’ ħut li ġie trattat b’ dan il - prodott.
In some cases this can be related to the use of the compound too early in the spawning season.
F’ xi każi dan seta ġara minħabba li l- prodott intuża kmieni ħafna fl- istaġun tal- bajd.
2/ 37 It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
Huwa rakkomandat li wara l- injezzjoni il- ħut jiġi strippjat f’ intervall ta ’ madwar 50 – 100 gradi ġranet.
For Arctic charr, injections should be given only if the water temperature is < 8°C.
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.
2/ 37 Għadu qatt ma ġie studjat l - effett fit- tul li dan il- prodott jista ’ jkollu fuq ħut tar- razza ttrattat.
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.
Wieħed għandu joqgħod attent ħafna li meta jinjetta l- prodott fil- ħut ma jintroduċix jew ixerred mard fil- ħut tar- razza.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali lill- annimali
Operators should wear gloves when mixing the concentrate solution with the solvent.
Uża ingwanti meta thallat il- konċentrat mas- solvent.
Avoid self injection.
Evita li tinjetta lilek innifsek.
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water.
F' każ li xxerred fuq il- ġilda jew iddaħħal is- soluzzjoni f’ għajnejk, laħlaħ sewwa bl- ilma.
The package insert or the label should be shown to the physician
F' każ ta ’ li xxerred il- konċentrat jew ftit mis- soluzzjoni fuq il- ġilda jew f’ għajnejk jew f’ każ li tinjetta lilek innifsek aċċidentalment, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ nformazzjoni li jkun fih ġewwa.
Operators should wash their hands after use of the product.
Aħsel idejk wara li tuża l- prodott.
4.6 Adverse reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravita)
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala u fi żmien il- ħalib jew zmien il- bajd
No information on interactions with other veterinary medicinal products is available.
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Fish should be anaesthetised.
Il - ħut għandhom jiġu illuppjati.
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 recommended dose is 32 µg/ kg body weight.
Id- doża rakkomandata hija ta ’ 32 mikrogrammi / kg ta ’ piż ħaj.
This 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 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 empty, sterile vial is intended to be used for mixing the concentrate and solvent.
Il- kunjett vojt u sterilizzat huwa ntenzjonat sabiex jitħalltu fih il- konċentrat u s- solvent.
Additional sterile vials will be supplied on request.
Jekk ikun hemm bżonn, jistgħu jingħataw aktar kunjetti steriliżżati.
3/ 37 The table below provides the required volume of concentrate and the required volume of solvent to obtain the preferred injection volume of 0.1 ml/ kg fish, 0.2 ml/ kg fish, 0.5 ml/ kg fish or 1 ml/ kg fish.
3/ 37 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 ’
Concentrate
Volum ta ’
to be injected
ħut li se jiġi injettat
volume
konċentrat
Solvent volume
Volum ta ’ solvent
* this volume will be minimized for the species with the largest body weights.
* dan il volum ikun minimizzat għall- ispeċijiet bl- akbar piż ħaj.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidot), (jekk ikun hemm bżonn)
An overdose will not accelerate the onset or increase the degree of ovulation.
Doża għolja mhux se taċċellera iż - żmien jew toħloq żjieda fil- bajd.
A reduction in the egg quality is seen after administration of doses above the recommended therapeutic dose.
Wara amministrazzjoni ta ’ dożi ogħla minn dawk terapewtiċi, kien hemm tnaqqis fil- kwalita tal- bajd.
No antidotes are available.
M’ hemm l- ebda antidot li wiehed jista ’ juża.
Zero days.
Xejn ġranet
PHARMACOLOGICAL PROPERTIES
5. 1 Tagħrif Farmakodinamiku
Pharmaceutical group: gonadotrophin-releasing hormone.
Gonadotrophin – releasing hormone.
Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH).
Azagly – nafarelin huwa prodott sintetiku li huwa simili għall - Gonadotrophin – releasing hormone (GnRH).
GnRH is synthesised by neurones in the hypothalamus in all vertebrate species.
GnRH hija sustanza magħmula minn newroni fil- hypothalamus fl- ispeċi vertebrati.
It controls reproduction in fish by modulating the secretion of the pituitary gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), also known in fish endocrinology as GtH-II and GtH-I, respectively.
Fir - riproduzzjoni tal- ħut dawn ta ’ l- aħħar huma magħrufa bhala GtH- II u GtH- I rispettivament.
GnRH analogues are peptides.
Kopji tal- GnRH huma peptidi.
Azagly-nafarelin, like other GnRH analogues, mimics the action of GnRH, through modulation of the secretion of LH and FSH in mammals and fish.
Azagly – nafarelin bħal kopji l- oħra tal- GnRH jaħdem billi jikkopja l- azzjoni tal- GnRH u jaffettwa l - konċentrazzjoni ta’ l- ormoni LH u FSH fil- ħut u l - annimali.
5.2 Pharmacokinetic particulars
5. 2 Tagħrif Farmakokinetiku
Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout.
Azagly – nafarelin jiġi assorbit malajr wara trattament intraperitonejali fit- troti.
The distribution and metabolism of azagly-nafarelin have not been studied in the target species.
Id - distribuzzjoni u l - metaboliżmu ta ’ dan il- prodott qatt ma ġew studjata fl- ispeċi indikata għat- trattament.
Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout.
Azagly – nafarelin jigi eliminat malajr mill- plasma wara trattament intraperitonjali fit- troti.