qanastek/EMEA-V3 huggingface dataset:
The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Lixka waħda hija biżżejjed sabiex tiżgura l- immunizzazzjoni attiva, sabiex tilqa ’ għal infezzjoni bil- virus tar- rabbja.
The distribution rate depends on the topography and on the population of the target species.
Ir- rata tat- tqassim tiddependi mit- topografija u mill- popolazzjoni ta ’ l- ispeċi li għaliha hu indikat il - prodott.
The minimum distribution rate is:
Ir- rata minima ta ’ tqassim hija:
- 13 baits per square km over the areas where fox / raccoon dog density indexes were equal or less
- 13- il lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densita ’ tal- volpijiet kelb raccoon
than 3 foxes / raccoon dogs seen per 10 km.
kienu daqs jew inqas minn 3 volpijiet / klieb raccoon li dehru f’ kull 10 km..
- 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3
- 20 lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densita ’ tal- volpijiet / klieb raccoon
foxes / raccoon dogs seen per 10 km.
kienu iktar minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km.
The administration of the vaccine at 10 times the recommended dosage induced no undesirable effects.
It- teħid tal- vaċċinazzjoni sa 10 darbiet iktar mid- doża rakkomandata ma wrietx effetti mhux mixtieqa.
Live viral vaccines ATCvet code:
Vaċċin virali ħaj Kodiċi ATĊ veterinarja:
Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Rabigen SAG2 huwa vaċċin kontra l- virus tar- rabbja inattivat li jittieħed mill- ħalq mill- volpijiet il - ħomor (Vulpes vulpes) u klieb raccoon (Nyctereutes procyonoides).
The active ingredient is a double low virulence mutant isolated from the SAD Bern strain of rabies virus by two successive selection steps in order to avoid natural reversion to the parental strain.
Is- sustanza attiva huwa mutant doppju ta ’ virulenza baxxa li ġie iżolat minn razza ta ’ grupp tal- virus tar- rabbja SAD Bern, permezz ta ’ żewġ proċeduri ta ’ selezzjoni suċċessivi sabiex jiġi evitat li jkun hemm riverżjoni naturali għall- virus parentali.
PHARMACEUTICAL PARTICULARS
3/ 23 Hija użata għall- immunizzazzjoni attiva tal- volpijiet u tal- klieb raccoon u hija karatteriżżata mill - sensibbilità ta ’ antikorpi speċifiċi ta ’ rabbja.
Vaccine:
Vaċċin:
Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid – Saccharose – Gelatin – Tryptone - Lactalbumin hydrolysate - Sodium chloride - Water for injection
Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid – Saccharose – Gelatin – Tryptone - Lactalbumin hydrolysate - Sodium chloride - Ilma għall- injezzjoni
Appetent matrix (bait):
Matriċi appetenti (lixka):
2 years at -20°C and 2 days at +25°C.
Sentejn f’ temperatura ta ’ - 20°Ċ u jumejn f’ temperatura ta ’ +25°Ċ.
Store in a freezer at -40°C to -20°C.
Aħżen fil- friża f’ temperatura ta ’ bejn - 40°Ċ sa - 20°Ċ.
Keep the boxes tightly closed.
Ipproteġi mid- dawl. ¯omm il- kaxxi magħluqa sew.
Liquid vaccine contained within an aluminium/ PVC sachet coated with an appetising matrix.
Vaċċin likwidu li qiegħed ġo qartas ta ’ l- aluminju/ PVC miksi b’ sustanza appetittiva.
The baits are successively packed in boxes of:
Il- lixka hija suċċessivament ippakkjati ġo kaxxi ta ’:
- 200 units (4x50)
- 200 unit (4x50)
- 400 units (2x200)
- 400 unit (2x200)
Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi l- materjal ħażin u lixki mhux imqiegħda fl- aħħar tal- ġurnata tat- tqassim billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill- Awtorità Kompetenti tal- pajjiż.
06516 Carros - France tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: dar@virbac. fr
06516 Carros - Franza tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e- mail: dar@ virbac. fr
4/ 22 9.
4/ 23 EU/ 2/ 00/ 021/ 002
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 ta ’ dan il- prodott mediċinali u veterinarju jinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'dan il- prodott mediċinali veterinarju huwa pprojbit jew jista ’ jkun ipprojbit ġo parti mit- Territorju tagħhom minħabba l- politika nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must consult the relevant Member State’ s Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża Rabigen SAG2 għandha tikkonsulta mal- Awtorita ’ Kompetenti tal- Pajjiż Membru dwar il- programmi ta 'vaċċinazzjoni attwali qabel timporta, tbiegħ, tissupplixxi u / jew tuża ’.
Restricted to duly designated competent administrative authorities.
Ristritt għal awtoritajiet amministrattivi kompetenti li huma magħżula apposta.
5/ 22 ANNEX II
5/ 23 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- U¯U
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- U¯U SIGUR U EFFETTIV
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance
L- isem u l- indirizz tal- manifattur tas- sustanza bijoloġika attiva
1ère Avenue - 2065 m 06516 Carros, France
1ère Avenue - 2065 m 06516 Carros, Franza
Manufacturing Authorisation issued on December 22nd 1997 by the Ministère de la solidarité, de la santé et de la protection sociale – Direction de la Pharmacie et du médicament – République Française.
L- Awtorizzazzjoni tal- Kummerċ ġiet maħruġa fit- 22 ta ’ Diċembru 1997 mill- Ministeru tas- Solidarjetà, tas- Saħħa u tal- Ħarsien Soċjali – Direttorat tal- Farmaċija u tal- mediċini – Repubblika Franċiża.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- U¯U
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu tal- prodott mediċinali veterinarju jista ’ jew jiġi jiġi pprojbit f’ ċertu Stati Membri fit- territorju sħiħ tagħhom jew parti minnu b’ mod konformi mal- politika tas- saħħa fuq l- annimali.
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must consult the relevant Member State’ s Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tipprovdi u/ jew tuża RABIGEN SAG2 għandha tikkonsulta ma ’ l- Awtorità Kompetenti ta ’ l- Istat Membru dwar il - programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/ jew tuża.
Restricted to duly designated competent administrative authorities.
Ristrett għal awtoritajiet amministrattivi kompetenti maħtura.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- U¯U SIGUR U EFFETTIV
7/ 22 ANNEX III
7/ 23 ANNESS III
9/ 22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 23 TIKKETTAR GĦAL KAXXA LI
200 unit box
Fiha 200 unit
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Rabigen SAG2 suspensjoni tittieħed mill- ħalq, għall- volpijiet ħomor u klieb raccoon.
Live attenuated rabies virus, SAG2 strain
Virus inattivat tar- rabbja, tar- razza SAG2
8 log10 - CCID50*/ dose
8 log10 - CCID50 * / doża
Excipients:
Eċipjenti:
Palatable matrix (bait) containing a tetracycline biomarker
Sustanza (lixka) appetittuża li hija magħmula minn biomarkatur ta ’ tetraċiklina
Oral suspension.
Suspensjoni li ttieħed mill- ħalq.
200 (4 x 50) vaccinal baits.
Kaxxa li fija 200 (4 x 50) lixka ta ’ tilqim.
The duration of protection is of at least 6 months.
INDIKAZZJONI( JIET)
The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Il- lixka hija mqassma fuq l- art jew mill- ajru skond il- qafas tar- regolamenti ta ’ kampanji ta ’ vaċċinazzjoni kontra r- rabbja..
They are intended to be eaten by foxes and raccoon dogs.
Huma maħsuba sabiex jittieklu mill- volpijiet u klieb raccoon.
The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
L - ammont ta ’ lixka waħda huwa biżżejjed sabiex jiżgura protezzjoni lill- volpi kontra r- rabbja.
The distribution rate depends on the topography and on the population of the target species.
Ir- rata tat- tqassim tiddependi mit- topografija u mill- popolazzjoni tal- volpijiet ta ’ l- ispeċi li għalihom hu ndikat il- prodott.
This minimum distribution rate is:
Din ir- rata minima ta ’ tqassim hija:
- 13 baits per square km over the areas where fox / raccoon dog density indexes were equal or
- 13- il lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densità tal- volpijiet / klieb raccoon
less than 3 foxes / raccoon dogs seen per 10 km.
kienu daqs jew inqas minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km.
foxes / raccoon dogs seen per 10 km.
kienu iktar minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km..
10/ 22 Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
It is recommended to wear rubber gloves.
Huwa rakkomandat ilbies ta ’ ingwanti tal- lastku.
People handling and distributing this vaccine should be vaccinated against rabies.
Dawk li jimmaniġġjaw u jqassmu din it- tilqima għandhom jiġu mlaqqma kontra r- rabbja.
Immunocompromised/ immunosuppressed individuals must not be allowed to handle this vaccine.
Dawk l- individwi li huma immunokompromessi/ imunodipressi m’ għandhomx jimmaniġġjaw dan il - vaċċin.
In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet i or the label to the physician.
F’ każ ta ’ esposizzjoni umana għas- sustanza attiva tal- vaċċin, għandu jtittieħed parir mediku immedjatament u jintwera il- fuljett informattivjew it- tikketta lit- tabib.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Peress li l- preżentazzjoni ta ’ din it- tilqima fiha traċċi ta ’ ġentamiċina u fiha tetraċiklina bħala bijoindikatur, jista ’ jkun li kultant jistgħu jiġu osservati xi reazzjonijiet ta ’ allerġija f’ annimali domestiċi li jistgħu jkunu belgħu l- lixka b’ mod inċidentali.
SPECIAL STORAGE CONDITIONS
KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦA¯EN
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX U¯ATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KA¯
Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin u lixki mhux imqiegħda fl- aħħar tal- ġurnata tat- tqassim billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill- Awtoritajiet Kompetenti tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- U¯U, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss.
Restricted to duly designated competent administrative authorities.
Għandu jingħata biss bi preskrizzjoni medika.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package insert for further information.
Ristrett għal awtoritajiet amministrattivi kompetenti li huma magħżula apposta.
06516 Carros - France
06516 Carros - Franza
12/ 22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
12/ 23 TIKKETTAR GĦAL KAXXA LI
400 unit box
Fiha 400 unit
Excipients:
Eċċipjenti:
Palatable matrix (bait) containing a tetracycline biomarker
Sustanza (lixka) appetittuża li fiha biomarkatur ta ’ tetraċiklina
Oral suspension.
Suspensjoni tittieħed mill- ħalq.
400 (2 x 200) vaccinal baits
Kaxxa li fiha 400 (2 x 200) lixka tal- vaċċin.
The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Il- lixka hija mqassma fl- art jew bl- ajru skond ir- regolamenti ta ’ kampanji ta ’ tilqim kontra r- rabbja.
They are intended to be eaten by foxes / raccoon dogs.
Hija maħsuba sabiex jittieklu mill- volpijiet / klieb raccoon.
The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
L- ammont ta ’ lixka waħda huwa biżżejjed sabiex jiżgura protezzjoni lill- volpi kontra r- rabbja.
The distribution rate depends on the topography and on the population of the target species.
Ir- rata tat- tqassim tiddependi mit- topografija u mill- popolazzjoni ta ’ l- ispeċi li għaliha hu indikat il - prodott
- 13 baits per square km over the areas where fox / raccoon dog density indexes were equal or
- 13- il lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densita ’ tal- volpijiet / kelb raccoon
- 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3
- 20 lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densita ’ tal- volpijiet / kelb raccoon kienu
foxes / raccoon dogs seen per 10 km.
iktar minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km.
13/ 22 Read the package leaflet before use.
Aqra l- fuljett tat- tagħrif qabel ma tuża.
It is recommended to wear rubber gloves.
Huwa rakkomandat l- ilbies ta ’ ingwanti tal- lastku.
People handling and distributing this vaccine should be vaccinated against rabies.
Dawk li jimmaniġġjaw u jqassmu dan il- vaċċin għandhom jiġu mlaqqma kontra r- rabbja.
In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ esposizzjoni umana għas- sustanza attiva tal- vaċċin, għarraf mal- ewwel lit- tabib u wrieħ il- fuljett ta ’ tagħrif jew it- tikketta.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Peress li l- preżentazzjoni ta ’ dan il- vaċċin fih traċċi ta ’ ġentamiċin u fiha tetraċiklina bħala bijoindikatur, kultant jistgħu jiġu osservati xi reazzjonijiet ta ’ ipersensitivita ’ f’ annimali domestiċi li inċidentalment ikunu belgħu il- lixka.
Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin u lixki mhux imqiegħda fl- aħħar tal- ġurnata tat- tqassim billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill- awtoritajiet kompetenti tal- pajjiż.
Keep out of the reach and sight of children.
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
14/ 22 14.
14/ 23 VIRBAC S. A.
06516 Carros - France
06516 Carros – Franza
15/ 22 MINIMUM PARTICULARS TO APPEAR ON SACHETS
15/ 23 QRATAS
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Rabigen SAG2 suspensjoni tttieħed mill- ħalq għal volpijiet ħomor u klieb raccoon.
{number}
Lott{ numru}
RABIES VACCINE DO NOT TOUCH
VAĊĊIN TAR- RABBJA - TMISSUX
Informative phone number: + 33 4 92 08 73 04
Numru tat- telefon informattiv: + 33 4 92 08 73 04
16/ 22 PARTICULARS TO APPEAR ON BAITS
16/ 23 LIXKI
1ère Avenue 2065 M L. I. D 06516 Carros France
1ère Avenue 2065 M L. I. D 06516 Carros Franza
{month/ year}
JISKADI {Xahar/ sena}
18/ 22 PACKAGE LEAFLET Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
18/ 23 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Rabigen SAG2 suspensjoni tittieħed mill- ħalq, għall- volpijiet ħomor u klieb raccoon
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
1 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, JEKK DIFFERENTI
06516 Carros France
06516 Carros - Franza
Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Rabigen SAG2 suspensjoni orali ttieħed mill- ħalq, għall- volpijiet ħomor u klieb raccoon.
Live attenuated rabies virus, SAG2 strain
Virus inattivat tar- rabbja, tar- razza
8 log10 CCID50*/ dose
8 log10 CCID50 * / doża
Palatable matrix (bait) containing a tetracycline biomarker
Sustanza (lixka) appetittuża li fiha bijoindikatur ta ’ tetraċiklina.
INDICATION
4 INDIKAZZJONI (JIET)
For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Immunizzazzjoni attiva tal- volpijiet ħomor u klieb raccoon sabiex tilqa ’ għal infezzjoni bil- virus tar - rabbja.
The duration of protection is of at least 6 months.
6.
No undesirable effects have been shown for Rabigen SAG2.
Ma rriżultawx effetti mhux mixtieqa mir- Rabigen SAG2.
As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Peress li l- presentazzjoni ta ’ din it- tilqima fiha traċċi ta ’ ġentamiċin u fiha tetraċiklina bħala biomarkatur, kultant jistgħu jiġu osservati xi reazzjonijiet ta ’ ipersensitivita ’ f’ annimali domestiċi li inċidentalment ikunu belgħu il- lixka.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
19/ 23 8 DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
It- teħid ta ’ lixka waħda huwa biżżejjed sabiex jiżgura protezzjoni lill- volpi kontra r- rabbja.
The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Il- lixka hija mqassma fuq l- art jew bl- ajru skond ir- regolamenti ta ’ kampanji ta ’ tilqim kontra r- rabbja.
They are intended to be eaten by foxes / raccoon dogs.
Huma maħsuba sabiex jittieklu mill- volpijiet / klieb raccoon.
The distribution rate depends on the topography and on the population of the target species.
Ir- rata tat- tqassim tiddependi mit- topografija u mill- popolazzjoni ta l - ispeċi li għalihom huwa indikat il- prodott.
- 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3
- 20 lixka għal kull km kwadru fiż- żoni fejn l- indiċi tad- densita ’ tal- volpijiet / kelb raccoon
Keep out of the reach and sight of children Store in a freezer at -40°C to -20°C.
¯omm fejn ma jintlaħaqx u ma jidhirx mit- tfal Aħżen fil- friża f’ temperatura ta ’ bejn - 40°C sa - 20°C.
For animal treatment only.
Għat- trattament ta 'l- annimali biss.
It is recommended to wear rubber gloves.
Huwa rakkomandat l- ilbies ta ’ ingwanti tal- lastiku.
The safety of the vaccine in pregnant and lactating animals has not been investigated.
Is- sigurtà tal- vaċċin ma ġietx investigata fil- każ ta ’ bhejjem tqal jew li huma fi żmien il- ħalib.
However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.
Imma l - virus tar- rabbja u virusijiet tal- vaċċin attenwat kontra r- rabbja normalment ma jakkumulawx fl- organi riproduttivi u mhumiex magħrufa li jaffettwaw direttament il- funzjonijiet riproduttivi.
Immunocompromised/ immunosuppressed individuals must not be allowed to handle this vaccine.
Dawk l- individwi li huma immunokompromessi/ immunosuppressati m’ għandhomx jimmaniġġjaw dan il- vaċċin.
In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ esposizzjoni umana għas- sustanza attiva tal- vaċċin, għarraf mal- ewwel lit- tabib u wrieħ l- fuljett informattiv, jew it- tikketta.
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must consult the relevant Member State’ s Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
L- importazzjoni, il- bejgħ, il- provvista u / jew l- użu ta 'dan il- prodott mediċinali veterinarju huwa pprojbit jew jista ’ jkun ipprojbit f' ċerti Stati Membri fuq it- territorju kollu tagħhom jew parti minnhom skond il- politika Nazzjonali tagħhom dwar is- saħħa tal- annimali..
Restricted to duly designated competent administrative authorities.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża Rabigen SAG2 għandha tikkonsulta mal- Awtorità Kompetenti tal- Pajjiż Membru dwar il- programmi ta 'vaċċinazzjoni attwali qabel timporta, tbiegħ, tissupplixxi u / jew tuża ’.
20/ 22 13.
20/ 23 Ristritt għal awtoritajiet amministrattivi kompetenti li huma magħżula apposta.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX U¯ATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KA¯
Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi l- materjal ħażin u l- lixki mhux imqiegħda fl- aħħar tal- ġurnata tat- tqassim billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill- awtoritajiet kompetenti tal- pajjiż.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall - Mediċini (EMEA) http: // www. emea. europa. eu
21/ 22 Ελλάδα VIRBAC HELLAS A. E.
23 rd Klm National Road Athens- Lamia
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 ta ’ użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk trid iktar informazzjoni dwar il- kundizzjoni jew il- kura medika ta ’ l- annimal, ikkuntattja lill - veterinarju tiegħek.
What is Reconcile?
X’ inhu Reconcile?
Reconcile is a veterinary medicine containing the active substance fluoxetine.
Reconcile huwa mediċina veterinarja li fiha s- sustanza attiva fluoxetine.
It is available as chewable tablets containing 8 mg, 16 mg, 32 mg or 64 mg fluoxetine.
Jiġi bħala pilloli li tista ’ tomgħodhom li fihom 8 mg, 16- il mg, 32 mg jew 64 mg ta ’ fluoxetine.
What is Reconcile used for?
Għalxiex jintuża Reconcile?
Reconcile is used, in combination with behavioural modification techniques, to assist in the treatment of dogs that have behavioural problems (separation anxiety) caused by separation from their owners, their normal home, or other dogs.
Reconcile jintuża, f’ kombinazzjoni ma ’ tekniki għall- modifika ta ’ l- imġiba, biex jassisti fit - trattament ta ’ klieb li jkollhom problemi ta ’ imġiba (ansjetà tas- separazzjoni) ikkawżata mill - firda mis- sidien tagħhom, mid- dar normali tagħhom, jew minn klieb oħrajn.
These behavioural problems might be expressed by excessive barking or howling, inappropriate defecation or urination in the house, or destruction of their surroundings.
Dawn il- problemi ta ’ l- imġiba jistgħu jiġu espressi b’ tinbiħ jew tnehid eċċessiv, ippurgar jew għemil ta ’ awrina mhux xieraq fid- dar jew qerda tal- madwar.
Reconcile should not be used on its own but only in dogs that are also undergoing behavioural therapy.
Reconcile m’ għandux jintuża waħdu iżda biss għal klieb li tkun qed issirilhom ukoll terapija ta ’ l- imġiba.
Reconcile tablets are given once a day.
Il- pilloli ta ’ Reconcile jingħataw darba kuljum.
The strength of tablet to be given is based on the dog’ s weight, so that the dog is given between 1 to 2 mg per kg of the dog’ s bodyweight per day.
Il- qawwa tal- pillola li għandha tingħata hija bbażata fuq il- piż tal- kelb, biex il- kelb jingħata bejn 1 mg u 2 mg kuljum għal kull kilogramma li jiżen.
The tablets are chewable and may be given either with or without food.
Il- pilloli jistgħu jintmagħdu u jittieħdu waħidhom jew ma ’ l- ikel.
How does Reconcile work?
Kif jaħdem Reconcile?
The active substance in Reconcile, fluoxetine, is a selective serotonin re-uptake inhibitor (SSRI).
Is- sustanza attiva f’ Reconcile, fluoxetine, hija inibitur selettiv ta ’ l- assorbiment mill- ġdid tas - serotonin (SSRI).
It works by preventing the neurotransmitter serotonin (5-hydroxytryptamine) from being taken back up into nerve cells in the brain and spinal cord.
Jaħdem billi jipprevjeni n- newrotrażmettitur serotonin (5 - hydroxytryptamine) milli jerġa ’ jiġi assorbit fiċ- ċelloli tan- nervituri fil- moħħ u fil- korda spinali.
Neurotransmitters such as serotonin are chemicals that transfer chemical signals from one nerve cell to another.
In- newrotrażmettituri bħas- serotonin huma kimiċi li jgħaddu sinjali kimiċi minn ċellola tan- nervituri għal oħra.
Low levels of serotonin in the central nervous system may be associated with depression, anxiety or aggression.
Livelli baxxi ta ’ serotonin fis- sistema nervuża ċentrali jistgħu jkunu assoċjati ma ’ dipressjoni, ansjetà jew agressjoni.
By blocking the re-uptake of serotonin into nerve cells, fluoxetine allows the levels of serotonin to remain higher.
Bl- imblukkar ta ’ l- assorbiment ta ’ serotonin fiċ- ċelloli tan- nervituri, fluoxetine iħalli l- livelli ta ’ serotonin jibqgħu ogħla.
This can improve the clinical signs (behavioural problems) of separation-related disorders in dogs.
Dan jista ’ jtejjeb is- sinjali kliniċi (problemi ta ’ imġiba) ta ’ disturbi relatati mas- separazzjoni fil - klieb.
In order to treat a dog with separation anxiety, the animal should not only receive medicines but also behavioural modification therapy.
Fit- trattament ta ’ kelb bl- ansjetà tas- separazzjoni, l- annimal m’ għandux jingħata mediċini biss iżda għandu jingħata wkoll terapija għall- modifikazzjoni ta ’ l- imġiba.
Behavioural modification therapy is the most important part of therapy; however, the use of the medicine allows for a more speedy recovery of the animal patient.
It- terapija tal- modifikazzjoni ta ’ l- imġiba hija parti importanti mit- terapija; madankollu, l- użu tal - mediċina jippermetti rkupru iktar malajr ta ’ l- annimal affettwat.
Reproduction is authorised provided the source is acknowledged. similar study looked at the efficacy in dogs that did not receive additional behavioural therapy.
Kif ġie studjat Reconcile?
In both of those studies the effectiveness of Reconcile was compared with that of placebo (a dummy treatment) for up to 8 weeks.
Reconcile ġie investigat f’ erba ’ studji differenti fi klieb domestiċi għal perjodu ta ’ mhux iktar minn 8 ġimgħat.
The last study was conducted under “ field conditions ” in a large number of dogs that were treated for separation anxiety in various veterinary practices, or clinics, in two European countries.
L- aħħar studju sar f’ kundizzjonijiet naturali f’ numru kbir ta ’ klieb li ġew ittrattati għall- ansjetà tas- separazzjoni f’ diversi kliniċi veterinarji, f’ żewġ pajjiżi Ewropej.
All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine that can be used to treat dogs with separation-related disorders).
Il- klieb kollha ngħataw terapija ta ’ l- imġiba u ġew ittrattati jew b’ Reconcile jew bi clomipramine (mediċina oħra li tista ’ tintuża fit- trattament tal- klieb b’ disturbi relatati mas- separazzjoni).
The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien it- tibdil f’ kull wieħed minn disa ’ tipi ta ’ mġiba magħrufin bħala indikaturi karatteristiċi ta ’ l- ansjetà tas - separazzjoni fil- klieb.
In all the studies Reconcile was given once a day, either with or without food.
Fl- istudji kollha Reconcile ingħata darba kuljum, waħdu jew ma ’ l- ikel.
What benefit has Reconcile shown during the studies?
X’ inhu l- benefiċċju ta ’ Reconcile li ntwera f’ dawn l- istudji?
The oral administration of Reconcile tablets, as 1 to 2 mg/ kg of fluoxetine once a day, is effective for the treatment of separation anxiety in dogs when used in conjunction with behavioural modification therapy.
L- għoti orali tal- pilloli ta ’ Reconcile, f’ doża ta ’ bejn 1 mg u 2 mg/ kg ta ’ fluoxetine darba kulum, hija effettiva għat- trattament ta ’ l- ansjetà tas- separazzjoni fil- klieb meta użati flimkien mat- terapija tal- modifika ta ’ l- imġiba.
The efficacy of Reconcile was higher when compared to placebo when behavioural modification therapy was also given to the dogs.
L- effikaċja ta ’ Reconcile kienet ikbar minn dik tal- plaċebo meta t- terapija tal- modifikazzjoni ta ’ l- imġiba ngħatat ukoll lill- klieb.
The efficacy was lower when no behavioural modification therapy was given.
L- effikaċja kienet iżgħar meta ma ngħatat l- ebda terapija għall- modifika ta ’ l- imġiba.
When given in combination with behavioural modification therapy, approximately 42% of dogs given Reconcile improved within one week, compared to only 17% of the dogs given placebo (plus the behavioural modification therapy).
Meta ngħata flimkien mat- terapija tal- modifikazzjoni ta ’ l- imġiba, madwar 42% tal- klieb li ngħataw Reconcile marru għall- aħjar fi żmien ġimgħa, meta mqabbla ma ’ 17% tal- klieb li ngħataw il- plaċebo (flimkien mat- terapija tal- modifikazzjoni ta ’ l - imġiba).
The fluoxetine-treated group continued to have a higher incidence of improvement over the course of the treatment period and by the end of the 8 weeks, approximately 72% of the fluoxetine- treated dogs had shown improved behaviour (a global severity score of 50%).
Il- grupp ittrattat bi fluoxetine baqa ’ jkollu inċidenza ogħla ta ’ titjib matul il- perjodu ta ’ trattament u sa tmiem it- tmien ġimgħa, madwar 72% tal- klieb ittrattati bi fluoxetine kienu wrew titjib fl- imġiba (punteġġ globali tas- severità ta ’ 50%).
The field study showed that Reconcile was as effective as clomipramine.
L- istudju fl- ambjent naturali wera li Reconcile kien effettiv daqs clomipramine.
In conjunction with behavioural modification therapy, Reconcile showed significant improvements in treating dogs for barking and inappropriate defecation or urination.
Flimkien mat - terapija tal- modifika ta ’ l- imġiba, Reconcile wera titjib sinjifikanti fit- trattament ta ’ l- imġiba għall- inbiħ u ppurgar u għemil ta ’ awrina mhux xierqa.
After 8 weeks, two separation anxiety behaviours were significantly improved in the fluoxetine group (inappropriate defecation and destructive behaviour).
Wara 8 ġimgħat, żewġ imġibiet ta ’ l - ansjetà tas- separazzjoni kienu tjiebu b’ mod sinjifikanti fil- grupp ta ’ fluoxetine (ippurgar mhux xieraq u mġiba distruttiva).
Six weeks after the end of treatment, five out of the nine separation anxiety behaviours were still improved in about a third of the treated dogs.
Sitt ġimgħat wara tmiem it- trattament, ħamsa minn kull disa ’ imġibiet ta ’ l- ansjetà tas- separazzjoni baqgħu jitjiebu f’ madwar terz mill- klieb ittrattati.
The rate of relapse at the end of the post-treatment phase was slightly higher in the fluoxetine group (28%) than in the clomipramine group (23%).
Ir- rata ta ’ klieb li rkadew fi tmiem il- fażi ta ’ wara t- trattament kienet ftit ikbar fil- grupp li ngħata fluoxetine (28%) meta mqabbel mal- grupp li ngħata clomipramine (23%).
What is the risk associated with Reconcile?
X’ inhu r- riskju assoċjat ma ’ Reconcile?
The most common side effects with Reconcile are anorexia (loss of appetite) and lethargy (unresponsiveness).
L- iktar effetti sekondarji komuni ma ’ Reconcile huma l- anoressija (nuqqas ta ’ aptit) u l - letarġija (nuqqas ta ’ rispons).
Less commonly, weight loss/ loss of condition, dilation of the pupils of the eye and, rarely, seizures were also observed.
Ġew osservati wkoll disturbi tal- pajp ta ’ l- awrina (bħal infezzjonijiet fil- bużżieqa ta ’ l- awrina, għemil irregolari ta ’ l- awrina u skumdità biex wieħed jgħaddi l- awrina) u sinjali relatati mas- sistema nervuża ċentrali (bħan- nuqqas ta ’ koordinazzjoni u d- diżorjentazzjoni).
To minimize the risk of adverse reactions, the recommended dose of Reconcile should not be exceeded.
Biex jitnaqqas ir- riskju ta ’ reazzjonijiet mhux mixtieqa, id- doża rakkomandata ta ’ Reconcile m’ għandhiex tinqabeż.
For a full list of all side-effects reported with Reconcile, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Reconcile, ara l- Fuljett ta ’ Tagħrif.
Reconcile tablets should not be used in dogs weighing less than 4 kg, or in dogs with epilepsy or with a history of seizures.
Il- pilloli ta ’ Reconcile m’ għandhomx jintużaw fi klieb li jiżnu inqas minn 4 kg, jew fi klieb bl - epilessija jew bi storja ta ’ aċċessjonijiet.
Reconcile should also not be used in dogs that may be hypersensitive (allergic) to fluoxetine or other SSRIs.
Reconcile lanqas ma għandu jintuża fi klieb li jistgħu jkunu allerġiċi għal fluoxetine jew SSRIs oħra.
Since Reconcile has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.
Paġna 2/ 3 tqal jew li jkunu qegħdin ireddgħu, l- użu tiegħu mhuwiex rakkomandat waqt it- tqala u t - treddigħ.
Reconcile tablets should not be used at the same time as many other medicines, especially medicines that can affect the central nervous system.
Il- pilloli ta ’ Reconcile m’ għandhomx jintużaw fl- istess żmien bħal ħafna mill- mediċini l- oħra, speċjalment mediċini li jistgħu jaffettwaw is- sistema nervuża ċentrali.
See the Package Leaflet for full information.
Ara l- Fuljett ta ’ Tagħrif għall- informazzjoni kollha.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għall- persuna li tagħti l- mediina jew tiġi f’ kuntatt ma ’ l- annimal?
Page 2/ 3 This veterinary medicine has been developed especially for dogs and is not for use in humans.
Din il- mediċina veterinarja ġiet żviluppata speċjalment għall- klieb u m’ għandhiex tintuża għall- bnedmin.
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Jekk persuna tieħu l- mediċina bi żball, ħu parir mediku immedjatament u uri l - fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
Why has Reconcile been approved?
Għaliex ġie approvat Reconcile?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Reconcile exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with behavioural problems caused by separation, and recommended that Reconcile be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Reconcile jegħlbu r- riskji meta jintuża flimkien ma ’ tekniki għall- modifika ta ’ l- imġiba bħala għajnuna għat- trattament ta ’ klieb bi problemi ta ’ l- imġiba kkawżati mis- separazzjoni, u rrakkomanda li Reconcile jingħata l- 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 jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Reconcile:
Informazzjoni oħra dwar Reconcile:
The European Commission granted a marketing authorisation valid throughout the European Union, for Reconcile to Eli Lilly and Company Ltd on 08.07.2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Reconcile lil Eli Lilly and Company Ltd fi 08. 07. 2008.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni dwar l - istatus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated in May 2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ Mejju 2008.
EMEA Number Invented Name
Numru ta ’ l- UE
Strength
Isem kummerċjali
Target species
Għamla Farmaċewtika
Route of administration
Speċi li Mod ta ’ fuqhom Amministrazzjon għandu i jintuża l - prodott
Withdraw al period
Perjodu ta ’ Tiżmim
Chewable tablets Dogs
Pilloli li jomogħdu
Oral use
Klieb
Bottle (HDPE)
Jittieħdu mill- ħalq Flixkun (HDPE)
Bottle (HDPE)
Jittieħdu mill- ħalq Bottle (HDPE)
Reconcile 8 mg chewable tablets for dogs Reconcile 16 mg chewable tablets for dogs Reconcile 32 mg chewable tablets for dogs Reconcile 64 mg chewable tablets for dogs
Reconcile 8 mg pilloli li tomgħod għal klieb Reconcile 16 mg pilloli li tomgħod għal klieb Reconcile 32 mg pilloli li tomgħod għal klieb Reconcile 64 mg pilloli li tomgħod għal klieb
(equivalent to 9.04 mg Fluoxetine hydrochloride) Reconcile
(ekwivalenti għal 9. 04 mg Fluoxetine hydrochloride) Reconcile 16 mg
(equivalent to 18.08 mg Fluoxetine hydrochloride) Reconcile
(ekwivalenti għal 18. 08 mg Fluoxetine hydrochloride) Reconcile 32 mg
(equivalent to 36.16 mg Fluoxetine hydrochloride) Reconcile
(ekwivalenti għal 36. 16 mg Fluoxetine hydrochloride) Reconcile 64 mg
(equivalent to 72.34 mg Fluoxetine hydrochloride)
(ekwivalenti għal 72. 34 mg Fluoxetine hydrochloride)
Chewable tablets.
Pilloli li tomgħod.
Speckled, tan to brown round chewable tablets, embossed on one side with a number (as listed below):
Pilloli tondi, li tomgħod imtektkin b’ lewn samrani għal kannella, intaljati fuq naħa waħda b’ numru (kif elenkat hawn isfel):
Reconcile 8mg tablets:
Reconcile pilloli ta ’ 8 mg:
4203 Reconcile 16mg tablets:
4203 Reconcile pilloli ta ’ 16 mg:
4205 Reconcile 32mg tablets:
4205 Reconcile pilloli ta ’ 32 mg:
4207 Reconcile 64mg tablets:
4207 Reconcile pilloli ta ’ 64 mg:
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defecation and/ or urination) and only in combination with behavioural modification techniques.
Bħala għajnuna fit- trattament ta ’ disturbi relatati mas- separazzjoni ta ’ klieb, manifestati b’ tiġrif u mġieba mhux xierqa (vokalizzazzjoni u ippurgar u/ jew awrina fejn mhux suppost) u dan biss flimkien ma ’ teknika ta ’ modifikazzjoni t’ imġieba.
Do not use in dogs weighing less than 4 kg.
Tużax fuq klieb li jiżnu anqas minn 4 kg.
Do not use in dogs with epilepsy or in dogs with a history of seizures.
Tużax fuq klieb b’ epilessija jew fuq klieb li għandhom storja ta ’ attakki tal- qamar.
2/ 33 4.4 Special warnings
2/ 33 Tużax f' każijiet ta 'sensittivita eċċessiva għal fluoxetine jew Impedituri Selettivi għar- ri- assorbiment ta ’ Serotonin (ISRS)
The safety of Reconcile has not been established in dogs under 6 months of age or weighing less than 4 kg.
Is- sigurtà ta ’ Reconcile għadha ma ġietx stabilita fi klieb li huma taħt is- 6 xhur jew jiżnu inqas minn 4kg.
Though rare, seizures may occur in dogs treated with Reconcile.
Għalkemm rari, l- attakki tal- qamar jistgħu iseħħu fi klieb ittrattati b ’ Reconcile.
Treatment should be stopped if seizures occur.
It- trattament għandu jitwaqqaf jekk ikun hemm attakki tal- qamar.
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ amministrazzjon aċċidentali lilek innifsek, fittex parir mediku minnufih u uri l- fuljett ta ’ tagħrif fil- pakkett lit- tabib.
In humans, the most common symptoms associated with overdose include seizures, somnolence, nausea, tachycardia, and vomiting.
Fil- bniedem, l- aktar sintomi komuni assoċjati ma doża eċċessiva jinkludu attakki tal- qamar, ngħas, dardir, takikardja, u remettar.
To minimize the risk of adverse reactions, the recommended dose should not be exceeded.
Sabiex jitnaqqas ir- riskju ta ’ reazzjonijiet mhux mixtieqa, id- doża rakkomandata m’ għandiex tiġi maqbuża.
Reported adverse reactions in dogs include:
Reazzjonijiet mhux mixtieqa rapportati fil- klieb jinkludu:
- Very common adverse events: decreased appetite (including anorexia); lethargy.
- Każijiet mhux mixtieqa komuni ħafna: tnaqqis fl- aptit (li jinkludi anoreksja); għeja.
- Common adverse events: urinary tract disorders (cystitis, urinary incontinence, urinary retention,
- Każijiet mhux mixtieqa komuni: disturbi tal- passaġġ ta ’ l- awrina (ċistite, inkontinenza awrinarja,
stranguria); central nervous system signs (incoordination, disorientation).
żamma ta ’ l- awrina, strangurja); sinjali fis- sistema nervuża ċentrali (nuqqas ta ’ koordinazzjoni, disorjentazzjoni).
- Uncommon adverse events: weight loss/ loss of condition; mydriasis.
- Każijiet mhux mixtieqa mhux komuni: telf fil- piż/ telf fil- kundizzjoni; midrijasi.
- Rare adverse events: seizures.
- Każijiet mhux mixtieqa rari: attakki tal- qamar.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, thus the use is not recommended during pregnancy and lactation.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u t- treddigħ, għalhekk l- użu mhux rakkomandat waqt it- tqala u t- treddigħ.
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, foetotoxic or maternotoxic effect.
Studji fil- laboratorju fil- firien u fniek ma pprovdewx evidenza ta ’ ħsara fit- tqala, ħsara fil- fetu jew ħsara lill- omm.
No effect on the reproductive capacity in male and female rats was noted.
L- ebda effett fuq il- kapaċità riproduttiva fil- firien irġiel jew in- nisa ma ġie nnotat.
Reconcile tablets should not be given concomitantly with veterinary medicinal products that lower the seizure threshold (e. g. phenothiazines such as acepromazine or chlorpromazine).
Il- pilloli Reconcile m’ għandhomx jingħataw flimkien ma ’ prodotti mediċinali veterinarji li jistgħu jnaqqsu s- solja ta ’ l- attakki tal- qamar (eż. fenotajazins bħal aċepromazin jew klorpromażin).
Do not use in conjunction with other serotonergic agents (e. g. sertraline) and monoamine oxidase inhibitors (MAOIs) [e. g., selegiline hydrochloride (L-deprenyl), amitraz] or tricyclic amines (TCAs) (e. g. amitriptyline and clomipramine).
M’ għandekx tuża flimkien ma ’ mediċini serotonerġiċi oħra (eż. sertralin) u impedituri ta ’ monoamine oxidase (MAOI) [eż. selegiline hydrochloride (L- deprenyl), amitraz] jew amini triċikliċi (TCAs) (eż. amitriptilin u klomipramin).
A 6-week washout interval should be observed following discontinuation of therapy with Reconcile tablets prior to the administration of any veterinary medicinal product that may adversely interact with fluoxetine or its metabolite, norfluoxetine.
Għandu jiġi osservat intervall ta ’ 6 ġimħat wara l- waqfien tat- terapija bil- pilloli Reconcile qabel l - għoti ta ’ kwalunkwe prodott mediċinali veterinarju li jista ’ b’ xi mod ikollu effetti mhux mixtieqa ma ’ fluoxetine jew il- metabolit tiegħu, norfluoxetine.
Fluoxetine is largely metabolised by the P-450 enzyme system, although the precise isoform in dogs is unknown.
3/ 33 Fluoxetine huwa prinċipalment metabolizzat bis- sistema ta ’ enżimi P- 450, għalkemm l- iżoform preċiż fil- klieb mhux magħruf.
Therefore, fluoxetine should be used with caution with other drugs.
Għalhekk, fluoxetine għandu jintuża b’ kawtela ma ’ mediċini oħra.
3/ 33 4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Reconcile tablets should be administered orally at a once daily dose of 1 to 2 mg/ kg bodyweight according to the dosage table below:
Il- pilloli Reconcile għandhom jiġu mogħtija mill- ħalq f’ doża ta ’ 1 sa 2 mg/ kg piż korporali darba kuljum ta ’ skond it- tabella tad- dożaġġi mogħtija hawn isfel:
Tablet strength (mg)
Qawwa tal- pillola (mg)
Number of tablets per day
Numru ta ’ pilloli kuljum
Reconcile 8 mg tablet
Reconcile pillola ta ’ 8 mg
Reconcile 16 mg tablet
Reconcile pillola ta ’ 16 mg Reconcile pillola ta ’ 32 mg Reconcile pillola ta ’ 64 mg
Clinical improvement with Reconcile tablets is expected within 1 to 2 weeks.
Titjib kliniku b’ pilloli Reconcile hu mistenni fi żmien ġimgħa sa ġimagħtejn.
If no improvement is noted within 4 weeks, case management should be re-evaluated.
Jekk l- ebda titjib ma jiġi nnotat fi żmien 4 ġimgħat, il- każ għandu jiġi evalwat mill- ġdid.
Clinical studies have shown that a beneficial response has been demonstrated for up to 8 weeks treatment with fluoxetine.
Studji kliniċi wrew rispons benefiċċjali meta ngħata sa 8 ġimgħat, trattament bil- fluoxetine.
Reconcile tablets may be given with or without food.
Il- pilloli Reconcile jistgħu jingħataw ma ’ l- ikel jew fuq stonku vojt.
Reconcile tablets are flavoured and most dogs will consume the tablet when offered by the owner.
Il- pilloli Reconcile għandhom togħma u l- biċċa l- kbira tal- klieb jikkunsmaw il- pillola meta tiġi offruta minn sidhom.
If a dose is missed, the next scheduled dose should be administered as prescribed.
Jekk ma titteħidx doża, id- doża li jkun imiss għandha tingħata kif preskritta.
At the end of treatment it is not necessary to taper or reduce doses because of the long half life of this product.
Fi tmiem it- trattament mhux meħtieġ li toqgħod tnaqqas bil- mod, jew tnaqqas id- doża minħabba li l- half- life twila ta ’ dan il- prodott.
At doses in excess of the recommended dose, observed side effects at the therapeutic dose, including seizures, are exacerbated.
F’ dożi ogħla minn dawk rakkomandati, effetti mhux mixtieqa osservati fid- doża terapewtika, li jinkludu attakki tal- qamar, jiħraxu.
In addition, aggressive behaviour was observed.
Barra minhekk, ġiet osservata mġieba aggressiva.
In clinical studies these side effects were stopped immediately upon intravenous administration of a standard dose of diazepam.
Fi studji kliniċi dawn l- effetti kollaterali waqfu minnufih ma ’ l- għoti ġol- vina ta ’ doża standard ta ’ diazepam.
Pharmacotherapeutic group: selective serotonin reuptake inhibitors (SSRI).
Grupp farmakoterapewtiku: impedituri silettivi tar - ri- assorbiment ta ’ serotonin (SSRI).
ATCvet code:
Kodiċi ATC veterinarja:
Fluoxetine and its active metabolite nor-fluoxetine have been shown to be highly selective inhibitors of serotonin uptake both in vitro and in vivo.
Fluoxetine u l- metabolit attiv tiegħu nor- fluoxetine intwerew li huma impedituri silettivi qawwija tat - teħid ta ’ serotinin, kemm in vitro u in vivo.
Fluoxetine does not act as a sedative.
Fluoxetine ma jaġixxix bħala sedattiv.