qanastek/EMEA-V3 huggingface dataset:
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Għaldaqstant huwa rakkommandat li ma tingħata l- ebda tilqima oħra flimkien ma din it- tilqima jew fl- istess żmien
It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not dissiminate systemically at the recommended dose.
Għal perjodu qasir, huwa kapaċi jimmultiplika lokalment fis- submukoża ta ’ fejn tingħata l- injezzjoni, u jinxtered fil- kavita oro- nasali għal ftit ġranet, madankollu dan l- istrejn tat- tilqim ma jgħixx fuq il - mukoża oro- nasali, u ma jinfirixx sistemikament bid- doża rakkomandata.
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination. From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection.
Huwa magħruf li numru żgħir ħafna ta ’ żwiemel jistgħu jiżviluppaw purpura haemorrhagica jekk dawn jiġu mlaqqma ftit wara nfezzjoni.
Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE.
Purpura haemorrhagica ma ġiet osservata fl- ebda wieħed mill- istudji tal- ħarsien tas- saħħa li saru waqt li kienet qed tiġi żviluppata Equilis StrepE.
For any information about this veterinary medicinal product, please contact the Marketing Authorisation Holder.
23/ 24 Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lis - sid tal - awtorizzazzjoni tal- kummerċ.
What is Equilis Te?
X’ inhu Equilis Te?
Equilis Te is a vaccine for use in horses.
Equilis Te huwa vaċċin għall- użu fiż- żwiemel.
It contains the toxoid (chemically inactivated toxin) from the tetanus bacterium.
Fih it- tossojde (tossin inattivat kimikament) mill- batterju tat- tetnu.
It is available as a suspension for injection.
Jiġi bħala sospensjoni għall- injezzjoni.
What is Equilis Te used for?
Għal xiex jintuża Equilis Te?
Equilis Te is used to vaccinate horses from six months of age against tetanus to prevent mortality.
Equilis Te jintuża fit- tilqim taż- żwiemel mill- età ta ’ sitt xhur kontra t- tetnu biex jimpedixxi l - mortalità.
Tetanus is an acute, often fatal disease caused by a neurotoxin produced by the bacterium Clostridium tetani.
It- tetnu huwa marda akuta, ħafna drabi fatali kkawżata minn newrotossin prodott mill- batterju Clostridium tetani.
The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Il- marda, li ġeneralment toriġina minn ġrieħi kontaminati, hija ikkaratterizzata minn riġidità (ebusija) ġenerali u spażmi konvulsivi tal- muskoli.
To retain protection against tetanus, horses need to be revaccinated.
Biex iżommu l- protezzjoni kontra t- tetnu, iż- żwiemel ikunu jridu jitlaqqmu mill- ġdid.
The first revaccination should be no later than 17 months after primary vaccination.
It- tieni tilqima tkun trid tingħata mhux iktar minn 17- il xahar wara l- ewwel tilqima.
How does Equilis Te work?
Kif jaħdem Equilis Te?
Equilis Te is a vaccine containing purified tetanus toxoid.
Equilis Te huwa vaċċin li fih it- tossojde tat- tetnu ppurifikat.
The toxoid is a toxin processed in order to remove its toxic effect, but retain its antigenic properties.
It- tossojde huwa tossin ipproċessat biex jitneħħielu l- effett tossiku tiegħu, iżda fl- istess ħin iżomm il- karatteristiċi antiġeniċi tiegħu.
When the product is given to horses, it helps the animals’ immune system to react quicker when the animal is naturally exposed to the Clostridium tetani bacterium.
Meta l- prodott jingħata liż- żwiemel, dan jgħin lis- sistema immuni tal- annimali tirreaġixxi iktar malajr meta l- annimal jiġi espost b’ mod naturali għall - batterju Clostridium tetani.
This helps to protect against tetanus.
Dan jgħin fil- protezzjoni kontra t- tetnu.
The vaccine also contains an ‘ adjuvant’ to stimulate a better immune response.
Il- vaċċin fih ukoll ‘ adjuvant ’ biex jistimula rispons immuni aħjar.
How has Equilis Te been studied?
Kif ġie studjat Equilis Te?
The safety of Equilis Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Is- sigurtà ta ’ Equilis Te ġiet studjata f’ diversi studji f’ kundizzjonijiet tal- laboratorju u f’ kundizzjonijiet prattiċi f’ għadd kbir ta ’ żwiemel, mill- età ta ’ xahrejn.
All studies were performed with Equilis Prequenza Te (comment: double; mentioned in next paragraph).
L- istudji kollha twettqu b’ Equilis Prequenza Te (kumment: id- doppju; imsemmi fil- paragrafu li jmiss).
It was concluded that the product is well tolerated by horses of different age.
Ġie konkluż li l- prodott huwa ttollerat tajjeb miż- żwiemel ta ’ etajiet differenti.
Studies in pregnant mares were also performed.
Twettqu wkoll studji fuq debbiet tqal.
No negative influence on gestation, foaling and offspring of mares was observed after vaccination at different times during pregnancy.
Ma ġiet osservata l- ebda influwenza negattiva fuq it- tqala u fuq il- frieħ taż- żwiemel wara t- tilqima f’ waqtiet differenti waqt it- tqala.
The effectiveness of Equilis Te has been studied in several trials under laboratory and field conditions.
L- effikaċja ta ’ Equilis Te ġiet studjata f’ diversi provi taħt kundizzjonjiet tal- laboratorju jew prattiċi.
Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus.
Ħafna mill- istudji twettqu b’ Equilis Prequenza Te, vaċċin li jipproteġi kontra l - influwenza ekwina kif ukoll kontra t- tetnu.
The main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.
Il- kejl ewlieni tal- effikaċja kien il- produzzjoni ta ’ livelli protettivi ta ’ antikorpi kontra t- tossojde tat- tetnu wara t- tilqima.
What benefit has Equilis Te shown during the studies?
Liema benefiċċju ta ’ Equilis Te ntwera f’ dawn l- istudji?
The studies showed that Equilis Te is an effective vaccine against tetanus to prevent mortality in horses from 6 months of age.
L- istudji wrew li Equilis Te huwa vaċċin effettiv kontra t- tetnu biex jimpedixxi l- mortalità fi żwiemel li għandhom minn 6 xhur ’ il fuq.
Horses developed protection two weeks after primary vaccination.
Iż- żwiemel żviluppaw protezzjoni ġimagħtejn wara t - tilqima primarja.
The duration of protection against tetanus was 17 months after primary vaccination and 24 months after the first revaccination.
Il- protezzjoni kontra t- tetnu kienet ta ’ sbatax- il xahar wara l- ewwel tilqima u 24 xahar wara t- tieni tilqima.
What is the risk associated with Equilis Te?
X’ riskji huma assoċjati ma ’ Equilis Te?
Swelling (max. diameter 5 cm) may occur at the injection site, either as diffuse hard or soft swelling.
Jista ’ jkun hemm nefħa iebsa jew ratba diffuża (b’ dijametru ta ’ mhux iktar minn 5 ċm) fis- sit tal- injezzjoni.
Why has Equilis Te been approved?
Għaliex ġie approvat Equilis Te?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Te exceeded the risks for the immunisation of horses from six months of age against tetanus to prevent mortality.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Equilis Te huma ikbar mir- riskji tiegħu għat- tilqim ta ’ żwiemel mill- età ta ’ sitt xhur kontra t - tetnu biex jimpedixxi l- mortalità.
The Committee recommended that Equilis Te should be given a marketing authorisation.
Il- Kumitat irrakkomanda li Equilis Te jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Page 2/ 3 ©EMEA 2008 Other information about Equilis Te:
Paġna 2/ 3 ©EMEA 2008 Tagħrif ieħor dwar Equilis Te:
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Te to Intervet International BV on 8 July 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Equilis Te lil Intervet International BV fit- 8 ta ’ Lulju 2005.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta jew fuq il- pakkett ta ’ barra.
EU Number
Numru EU
Invented Name
Isem mgħoti
Target species
Speċi li jintuża l - prodott
Route of administration
Metodu ta’ amministrazzjoni
Packaging
Ippakjar
Withdrawal period
Qies tal - Perjodu pakett ta’ tiżmim
Tetanus toxoid ≥ 30 IU/ ml
Toksojd tat – tetnu ≥ 30 IU/ ml
Intramuscular
Fil- muskolu
Vials (Type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Vjal tal- ħġieġ Tip I magħluq b tapp tal - gomma u ssiġillat b ’ kappa tal - aluminjum.
10 glass vials
10 vjali Xejn ġranet tal- ħġieġ
Pre-filled syringes (Type I glass) with a plunger and cap tip of halogenobutyl rubber
Siringa tal - ħġieġ Tip I, mimlija għal - lest bi planġer b’ tarf tal - gomma u magħluq b’ tapp tal - gomma.
10 pre-filled syringes
10 siringi Xejn ġranet mimlija għal- lest
Equilis Te, suspension for injection, for horses
Equilis Te, suspensjoni għall- injezzjoni, għaż- żwiemel
Per dose of 1 ml:
Kull doża ta ’ ml
Active substance
Sustanza Attiva:
40 Lf1
40 Lf1 Toksojd tat– tetnu
375 µg 125 µg 62.5µg
375 mikrogrammi 125 mikrogrammi 62. 5 mikrogrammi
For a full list of excipients, see section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti mhux attivi, ara
PHARMACEUTICAL FORM
s- sezzjoni 6. 1.
4.1 Target species
Suspensjoni għal injezzjoni
Horses
TAGĦRIF KLINIKU
4.2 Indications for use, specifying the target species
4. 1 Speċi li fuqhom ser jintuża l- prodott
Onset of immunity:
Żwiemel
2 weeks after the primary vaccination course
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l - prodott.
Duration
Immunizzazzjoni attiva ġħal żwiemel ta ’ sitt xhur jew aktar kontra t- tetnu biex tipprevjeni l- imwiet.
of immunity:
Bidu ta ’ immunita:
17 months after the primary vaccination course 24 months after the first revaccination
2 ġimgħat wara l- ewwel kors ta ’ tilqim 17- il xahar wara l- ewwel kors ta ’ tilqim 24 xahar wara l- ewwel revaċċinazzjoni
4.4 Special warnings
4. 4 TWISSIJIET SPEĊJALI
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Il- mor m ’ għandux jitlaqqam qabel jagħlaq is- sitt xhur, speċjalment jekk imwieled minn dwieb li tlaqqmu għat- tieni darba fl- aħħar xahrejn ta ’ tqala, għax hemm il- possibilita ta ’ interferenza ma l - antikorpi ta ’ l- omm.
Eur. potency test
Prekawzjonijiet speċjali għall- użu fl- annimali 1 Qies ta ’ ekwivalenza ta ’ flokulazzjoni; jikkorispondu ma ≥30IU/ ml sirum tal- fenek tal- Indi fit- test ta ’ potenza tal- Farmakopeja Ewropeja
2/ 16 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 16 Annimali b ’ saħħithom biss għandhom jiġu mlaqqma.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur, regressing within 2 days.
Nefħiet mifruxa (iebsin jew rotob, diametru mass.
Pain at the injection site can occur occasionally.
5 cm) jistgħu jfeġġu, li jonqsu fi żmien jumejn.
In some cases fever may occur for 1 day, and up to 3 days in exceptional circumstances.
Okkażjonalment jista ’ jkun hemm uġiegħ fil- post ta ’ l- injezzjoni.
Intramuscular use
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Vaccination schedule:
Għall - użu intramuskolari.
Primary vaccination course
Skeda għat- tilqim
Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
L- ewwel kors ta tilqim Agħti doża waħda (1 ml) fil- muskolu, skond din l- iskema: • L- ewwel kors ta tilqim: l- ewwel injezzjoni wara 6 xhur mit- twelid u t- tieni waħda, 4 ġimgħat wara.
The first revaccination is given not later than 17 months after the primary vaccination course.
Rivaċċinazzjoni L- ewwel revaċċinazzjoni tingħata mhux aktar tard mis 17- il xahar wara l- ewwel kors ta ’ vaċċinazzjoni.
Thereafter a maximum interval of two years is recommended (see scheme).
T1
V1 0
t4
V2 1
T2
V3 18
T3
V4 42 months
42 xahar
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
F ’ każ ta ’ riskju akbar ta ’ infezzjoni jew nuqqas ta teħid ta kolostrum, tilqima addizjonali tista ’ tingħata fir- raba xahar segwita bil- programm komplut ta ’ vaċċinazzjoni (l- ewwel kors ta ’ tiqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus.
Immunita attiva u passiva f daqqa (tilqima ta ’ emerġenza) Il- vaċċin jista jingħata ma Tetanus- Serum tal- Intervet lil żwiemel midruba li mhumiex imlaqqma kontra t- tetnu.
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
F dak il- każ, l- ewwel doża (T1) tal- vaċċin tista tingħata flimkien mad- doża profilattika adatta ta ’ Tetanus- Serum tal- Intervet iżda f ’ post tal- injezzjoni differenti u b’ labar u siringi differenti.
The second dose of the vaccine (V2) should be administered 4 weeks later.
It- tielet
A third vaccination with Equilis Te should be repeated at least four weeks later.
3/ 16 tilqima bl - Equilis Te għandha terġa ’ tingħata tal- inqas 4 ġimghat wara.
Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
L - użu flimkien ta ’ Equilis Te u Tetanus- Serum tal- Intervet jista ’ jnaqqas l- immunita attiva kontra t- tetnu meta mqabbla ma żwiemel oħra mlaqqma bl Equilis Te biss (mingħajr l- antitoksin tas- sirum tat- tetnu).
3/ 16 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination.
Wara injezzjoni doppja ta vaċċin, l- ebda effetti mhux mixtieqa, apparti dawk deskritti f ’ parti 4. 6 ma ġew osservati ħlief għal ftit sintomi ta ’ dipressjoni fil - jum tal - vaċċinazzjoni.
To stimulate active immunity against tetanus ATC-vet code:
Kodici ATĊ veterinarja:
Purified Saponin, Cholesterol, Phosphatidylcholine, traces of Formaldehyde
Saponin purifikat, Kolesterol, Fosfatidilkolin, traċċi ta ’ Formalina
6.4 Special precautions for storage
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Fjal tal- ħġieġ Tip I magħluq b tapp tal- gomma u ssiġillat b ’ kappa tal - aluminjum.
Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Siringa tal- ħġieġ Tip I, mimlija għal- lest bi planġer b’ tarf tal- gomma u magħluqa b’ tapp tal- gomma.
Cardboard box with 10 pre-filled syringes with needles.
Kaxxa( i) tal - kartun b ’ 10 siringi tal- ħġieġ bil- labar, mimlija għall- lest.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) 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 >
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) 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
76 35 041 Marburg Germany
76 35 041 Marburg Ġermanja
RESTRICTIONS REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU
Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju li jingħata biss b’ riċetta veterinarja.
PROHIBITION OF SALE, SUPPLY AND/ OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
MRL status Annex II for all food producing species (under Quillaia saponins)
Anness II għall- speċi li jipproduċu l - ikel (ta’ ħt Quillaia saponins)
Covered by Annex II entry for authorised food additives with an E number (E339)
Kopert b ’ Aness II għall- additivi ta ’ l - ikel awtorizzati b numru E (E339)
Annex II for all food producing species (approved as food additives with an E number (E340))
Kopert b ’ Aness II għall- additivi ta ’ l - ikel awtorizzati b ’ numru E (E340)
Annex II for all food producing species
Anness II għall- speċi kollha li jittieklu
Tetanus toxoid 40 Lf/ ml
Toksojd tat- tenu 40 Lf/ ml
Suspension for injection.
Suspensjoni għall- injezzjoni
Horses
Żwiemel.
Active immunisation of horses against tetanus.
Immunita attiva kontra t- tetnu fiż- żwiemel.
Zero days
Xejn ġranet
Read package leaflet before use.
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża
EXP
Jiskadi
Read package leaflet before use (Comment:
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża (Kumment:
Statement will be printed only once on the package item)
Id- dikjarazzjoni tkun stampata darba biss fuq il- prodott ippakjat)
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only-To be supplied only on veterinary prescription
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni veterinarja.
< Lot >
Lott
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA 'DOŻI
13/ 16 PACKAGE LEAFLET FOR Equilis Te, suspension for injection, for horses
13/ 16 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Equilis Te, suspensjoni għall- injezzjoni, għaż- żwiemel
Per dose of 1 ml:
Kull doża ta 1 ml
Active substance Tetanus toxoid
Sustanza Attiva:
40 Lf2
40 Lf2 Toksojd tat– tetnu
375 µg 125 µg 62.5 µg
375 mikrogrammi 125 mikrogrammi 62. 5 mikrogrammi
Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
Immunizazjoni attiva ġħal żwiemel ta aktar minn sitt xhur kontra t- tetnu biex tipprevjeni l- imwiet.
Duration of immunity:
Kemm isservi l- immunita:
17 months after the primary vaccination course 24 months after the first revaccination
2 ġimgħat wara l- ewwel kors ta tilqim 17- il xahar wara l- ewwel kors ta tilqim 24 xahar wara l- ewwel revaċċinazzjoni
None
Xejn 2 Qies ta ’ ekwivalenza ta ’ flokulazzjoni; jikkorispondu ma ≥30IU/ ml sirum tal- fenek tal- Indi fit- test ta ’ potenza tal- Farmakopeja Ewropeja.
2 Flocculation equivalents; corresponds with ≥ 30 IU/ ml guinea pig serum in the Ph. Eur. potency test
F xi każijiet jista ’ jkun hemm deni għal ġurnata u f’ ċirkustanzi eċċezjonali ġieli jdum għal tlett ijiem
14/ 16 7.
14/ 16 Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
1 ml
1 ml Għall - użu intramuskolari.
Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
L- ewwel kors ta tilqim Amministra doża waħda (1 ml) fil- muskolu, skond din l- iskema: • L- ewwel kors ta ’ tilqim: l- ewwel injezzjoni wara 6 xhur mit- twelid u tieni waħda 4 ġimgħat wara.
The first revaccination is given not later than 17 months after the primary vaccination course.
Rivaċċinazzjoni L- ewwel rivaċċinazzjoni tingħata mhux aktar tard mis 17- il xahar wara l- ewwel kors vaċċinazzjoni.
Thereafter a maximum interval of two years is recommended (see scheme).
Minn hemm il- quddiem, intervall ta ’ massimu sentejn huwa rakkomandat (ara skema).
V4 42 months
42 xahar Equilis Te Equilis Te Equilis Te
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
F każ ta ’ riskju akbar ta ’ infezzjoni jew nuqqas ta teħid ta ’ kolostrum, tilqima addizjonali tista ’ tingħata fir- raba xahar segwita bil- programm komplut ta ’ vaċċinazzjoni (l- ewwel kors ta ’ tiqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
F dak il- każ, l- ewwel doża (T1) tal- vaċċin tista ’ tingħata flimkien mad- doża profilattika adatta ta ’ Tetanus- Serum tal- Intervet iżda f ’ post tal- injezzjoni differenti u b’ labar u siringi differenti.
A third vaccination with Equilis Te should be repeated at least four weeks later.
It- tielet tilqima bl - Equilis Te għandha terġa ’ tingħata tal- inqas 4 ġimghat wara.
Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
L - użu flimkien ta ’ Equilis Te u Tetanus- Serum tal- Intervet jista ’ jnaqqas l- immunita attiva kontra t- tetnu meta mqabbla ma żwiemel oħra mlaqqma bl Equilis Te biss mingħajr l- antitoksin tas- sirum tat- tetnu.
Allow the vaccine to reach a temperature of 15°C - 25°C.
Ħalli t- temperatura tal- vaċċin tilħaq bejn 15°C - 25°C qabel l- użu.
Administer 1 ml of vaccine i. m..
Agħti 1 ml tal - vaċċin fil- muskolu.
Only healthy animals should be vaccinated.
Annimali b’ saħħithom biss għandhom jiġu mlaqqma.
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
F' każ li tinjetta lilek innifsek, fittex tabib mal - ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe tilqima oħra.
Do not mix with any other vaccine or immunological product.
Tħallatx ma l- ebda tiqima oħra jew prodott immunoloġiku.
Package sizes:
Daqs tal- pakketti:
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakkett jistgħu qegħdin fis- suq.
For any information about this veterinary product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- awtorizzazzjoni tal- kummerċ
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 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 tixtieq iktar informazzjoni relatata mar- rakkomandazzjonijiet tas - CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is EQUIOXX?
X’ inhu EQUIOXX?
EQUIOXX contains the active substance firocoxib in an oral paste for horses (8.2 mg/ g).
EQUIOXX fih is- sustanza attiva firocoxib f’ pejst orali għaż- żwiemel (8. 2 mg/ g).
This medicine is the same as Previcox oral paste for horses, which is already authorised in the European Union.
Din il - mediċina hija bħall- pejst orali Previcox għaż- żwiemel, li hija diġà awtorizzata fl- Unjoni Ewropea.
The company that makes Previcox has agreed that its scientific data can be used for EQUIOXX.
Il- kumpanija li tipproduċi Previcox qablet li l- informazzjoni xjentifika tagħha tista 'tintuża għal EQUIOXX.
What is EQUIOXX used for?
Għal x' hiex jintuża EQUIOXX?
EQUIOXX is used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) and reduce the lameness that is associated with the disease in horses.
EQUIOXX jintuża għat- tnaqqis tas- sintomi ta ’ osteoartrite (nefħa u wġigħ tal- ġogi) u għat - tnaqqis taz- zappip assoċjat ma ’ din il- marda fiż- żwiemel.
The dose is 0.1 mg firocoxib per kg bodyweight, given once a day.
Id- doża hija ta ’ 0. 1 mg firocoxib għal kull kg ta ’ piż tal- ġisem, li tingħata darba kuljum.
EQUIOXX is presented as a paste with a special syringe that allows the right amount of medicine to be drawn and given directly into the horse’ s mouth.
EQUIOXX jiġi f’ pejst b’ siringa speċjali li tippermetti li jinġibed l- ammont meħtieġ tal - mediċina li jingħata direttament fil- ħalq taż- żiemel.
The duration of treatment will depend on the horse’ s response, but should not exceed 14 days.
It- tul ta ’ żmien tat- trattament jiddependi fuq ir- rispons taż- żiemel, iżda m’ għandux jaqbeż l- 14- il jum.
How does EQUIOXX work?
Kif jaħdem EQUIOXX?
The active substance in EQUIOXX, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘ cyclo-oxygenase-2 (COX-2) inhibitors’ (or Coxibs).
Is- sustanza attiva fl- EQUIOXX, firocoxib, hija mediċina antinfjammatorja mhux sterojdali (NSAID) li tappartjeni għall- grupp ta ’ mediċini msejħa ‘ inibituri ċiklo- ossiġenażi- 2 (COX- 2) ’ (jew Coxibs).
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Timblokka l- enzima COX- 2, biex b’ hekk titnaqqas il- produzzjoni tal - prostaglandini, sustanzi involuti fil- proċess ta ’ l- infjammazzjoni.
By reducing the production of prostaglandins, EQUIOXX helps reduce the symptoms of inflammation, including pain.
Billi titnaqqas il- produzzjoni tal- prostaglandini, EQUIOXX jgħin biex inaqqas is- sintomi ta ’ l- infjammazzjoni, inkluż l - uġigħ.
How has EQUIOXX been studied?
Kif ġie studjat EQUIOXX?
EQUIOXX has been studied in laboratory animals, as well as in horses that were treated in various veterinary practices/ clinics across Europe (“ clinical studies”).
EQUIOXX ġie studjat f’ annimali tal- laboratorju, kif ukoll fi żwiemel li kienu ttrattati b’ diversi studji/ kliniċi veterinarji madwar l- Ewropa (“ studji kliniċi ”).
The studies looked at the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Żewġ studji multiċentriċi twettqu (wieħed fl- Istati Uniti u l- ieħor fl- Ewropa) biex l- effikaċja, is- sigurtà u l- aċċettabilità ta ’ firocoxib f’ kundizzjonijiet normali jitqabblu ma dawk ta ’ 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. effectiveness of the medicine in improving lameness, pain on manipulation/ palpation, joint swelling and ability to move.
L- istudji eżminaw l- effikaċja tal - mediċina fit- titjib taz- zappip, l- uġigħ meta saret manipulazzjoni/ palpitazzjoni, in- nefħa tal - ġogi u l- kapaċità ta ’ ċaqliq.
What benefit has EQUIOXX shown during the studies?
X' benefiċċji wera EQUIOXX f' dawn l- istudji?
EQUIOXX oral paste administered once daily for 14 days at a dose of 0.1 mg/ kg improved clinical scores for lameness and soft tissue injuries in horses and also helped relieve pain and inflammation associated with osteoarthritis in horses.
Il- pejst orali EQUIOXX li ngħata darba kuljum għal 14- il jum f’ doża ta ’ 0. 1 mg/ kg, tejjeb il - punteġġi kliniċi għaz- zappip u l- korriment relatat mat- tessut artab fiż- żwiemel u għen ukoll biex itaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- osteoartrite fiż- żwiemel.
What are the side-effects of EQUIOXX?
X’ inhuma l- effetti sekondarji ta ’ EQUIOXX?
The side effects of EQUIOXX are typical for those seen with other medicines in this class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/ diarrhoea or lethargy (unresponsiveness).
L- effetti sekondarji ta ’ l- EQUIOXX huma tipiċi ta ’ dawk li jirriżultaw minn mediċini oħra f’ din il- klassi (NSAIDs) bħal feriti orali (ħsara fit- tessut) fil- ħalq taż- żwiemel, ħmieġ artab/ dijarrea jew letarġija (nuqqas ta ’ rispons).
These reactions are generally temporary and reversible when the treatment is stopped.
Dawn ir- reazzjonijiet huma ġeneralment temporanji u reversibbli meta jitwaqqaf it- trattament.
EQUIOXX must not be administered with corticosteroids or other NSAIDs.
EQUIOXX m’ għandux jingħata mal- kortikosterojdi jew NSAIDs oħrajn.
Care should also be taken when used with medicines which have an effect on the kidney such as diuretics.
Għandha tingħata attenzjoni ukoll meta jintuża ma ’ mediċini li jkollhom effett fuq il- kliewi bħad- djuretiċi.
Wash hands after use of the product.
Aħsel idejk wara l- użu tal- prodott.
Avoid contact with eyes and skin.
Evita l- kuntatt ma ’ l- għajnejn u l- ġilda.
Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Nisa f’ età fertili għandhom jevitaw il- kuntatt mal- prodott, jew għandhom jilbsu ingwanti li jintremew wara li jintużaw meta jkunu qegħdin jagħtu l- prodott.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Fil- każ ta ’ inġestjoni aċċidentali, itlob parir mediku minnufih u uri l- fuljett ta ’ tagħrif jew it - tikketta lit- tabib.
What is the time to allow before a horse can be slaughtered and the meat used for human consumption (withdrawal period)?
X’ inhu ż- żmien li għandu jitħalla qabel iż- żiemel jista ’ jinqatel u l- laħam jintuża għall- konsum mill- bniedem (perjodu ta ’ rtirar)?
After the last day of treatment with EQUIOXX, horses should not be slaughtered for 26 days.
Wara l- aħħar jum ta ’ trattament bl- EQUIOXX, iż- żwiemel m’ għandhomx jinqatlu għas- 26 jum oħra.
The use of EQUIOXX is not permitted in mares producing milk for human consumption.
L- użu ta ’ EQUIOXX mhux permess fi dwieb li jipproduċi l- ħalib għall- konsum mill- bniedem.
Why has EQUIOXX been approved?
Għaliex ġie approvat EQUIOXX?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of EQUIOXX exceed the risks for the treatment of relief of pain and inflammation in horses and recommended that EQUIOXX be given a marketing authorisation.
Il- Kumitat dwar il- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l - benefiċċji ta ’ EQUIOXX huma aktar mir- riskji għat- trattament tat- tnaqqis ta ’ l- uġigħ u l - infjammazzjoni fiż- żwiemel u rrakomanda li EQUIOXX 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 jista 'jiġi kkonsultat fil- modulu 6 ta' dan l - EPAR.
Other information about EQUIOXX:
Tagħrif ieħor dwar EQUIOXX:
The European Commission granted the marketing authorisation valid throughout the European Union, for EQUIOXX to Merial on 25/ 06/ 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal EQUIOXX lil Merial fi 25. 06. 2008.
This summary was last updated in June 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Name
Isem kummerċjali
Oral paste
Pejst tal- ħalq
Oral use
Mill- ħalq
Pre-filled syringe (PP)
Siringa mimlija għal - lest (PP)
1 pre-filled syringe
Siringa mimlija għal- lest
Meat and offal:
Laħam u l - ġewwieni:
26 days
26 ġurnata
EQUIOXX 8.2 mg/ g oral paste for horses.
EQUIOXX pejst tal- ħalq ta ’ 8. 2 mg/ g għaż- żwiemel.
Firocoxib 8.2 mg/ g
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
For a full list of excipients, see section 6.1.
Kull siringa fiha 7. 32g ta ’ pejst u tagħti:
Oral paste.
Pejst tal- ħalq.
White to off-white paste.
Pejst ta ’ kulur abjad sa ’ abjad maħmuġ.
Horses.
Żwiemel.
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Biex ittaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite fiż- żwiemel u biex tnaqqas it- tizpip assoċjat fiż- żwiemel.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.
Tużax f’ annimali li qed isofru minn disturbi u emorraġija gastrointestinali u minn indeboliment tal - fwied, tal- qalb jew tal- kliewi jew li qed isofru minn disturbi tad- demm.
Do not use in breeding, pregnant or lactating animals.
Tużax f’ annimali tar- razza, li huma tqal jew qed jagħtu l- ħalib.
Do not use concomitantly with corticosteroids or other NSAIDs.
Tużax flimkien ma kortikosterojdi jew mediċini oħra anti- infjammatorji mhux sterojdi.
Do not use in animals less than 10 weeks.
Tużax f’ annimali ta ’ inqas minn 10 ġimgħat.
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
L- użu tal- prodott għandu jitwaqqaf jekk ikun hemm xi effetti kollaterali u jittieħed il- parir ta ’ tabib veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity.
Evita l- użu f’ annimali diżidrati, hypovolaemic jew hypotensive, peress li jista ’ jkun hemm riskju potenzjali ta ’ żieda ta ’ tossiċità fil- kliewi.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
L- użu flimkien ma mediċina li hi potenzjalment nefrotossika għandu jiġi evitat.
The recommended treatment dose and duration should not be exceeded.
Id- doża u t- tul tal- kura irrikmandati m’ għandhomx jiġu maqbuża.
2/ 17 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 17 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Jekk tibla ’ bi żball, fittex parir ta ’ tabib immedjatament u uri il- fuljett tal- pakkett jew it- tikketta lit - tabib.
Avoid contact with eyes and skin.
Evita kuntatt ma ’ l- għajnejn u l- ġilda.
If it occurs, rinse affected area immediately with water.
Jekk dan jiġri, laħlaħ l- erja effettwata immedjatament bl- ilma.
Wash hands after use of the product.
Aħsel idejk wara li tuża l- prodott.
Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Nisa ta ’ eta ’ li jistgħu jkollhom it- tfal għandhom jevitaw kuntatt mal- prodott jew jilbsu ngwanti li jintremew, meta jkunu qed jamministraw il- prodott.
Lesions (erosion/ ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Leżjonijiet (slieħ/ ulċeri) tal- mukosa orali u tal- ġilda madwar il- ħalq jistgħu jiġu osservati kultant f’ annimali li jkunu qegħdin jingħataw il- kura.
Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.
Tipikament, dawn il- leżjonijiet huma ħfief u jmorru mingħajr kura, iżda l- leżjonijiet orali jistgħu ikunu assoċjati mal- formazzjoni tal- bżieq u edema tax - xufftejn u ta ’ l- ilsien.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- Tqala u fi żmien il- ħalib u meta jbidu l- bajd
No data is available in horses.
M’ hemm l- ebda informazzjoni fiż- żwiemel.
However, studies with laboratory animals have shown embryo- foetotoxicity, malformations, delayed parturition and decreased pup survival.
Madanakollu studji fuq annimali fil- laboratorju urew tossicita ’ fl- embriju/ fetu, malformazzjoni, dewmien biex l- annimali jweldu u numru inqas ta ’ frieħ li jsalvaw.
Therefore, do not use in breeding, pregnant or lactating animals.
Għaldaqstant tużax f’ annimali tat- tagħmir, tqal, jew li jagħtu l- ħalib.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects.
NSAID oħra, dijuretiċi u sustanzi li għandhom kapaċita ’ għolja li jeħlu mal- proteini jistgħu jikkompetu mal- prodott u jwasslu għall- effetti tossiċi.
Do not use concomitantly with corticosteroids or other NSAIDs.
Tużax fl- istess ħin ma kortikosterojdi jew NSAID oħra.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed.
Kura minn qabel b’ sustanzi oħra ta ’ kontra l- infjammazzjoni tista iżżid l- effetti mhux mixtieqa jew toħloq oħrajn u għaldaqstant għandu jiġi osservat perijodu mingħajr kura b’ dawn il- prodotti.
The treatment- free period should take into account the pharmacological properties of the products used previously.
Il - perijodu mingħajr kura għandu jikkunsidra il- kwalitijiet farmakoloġiċi tal- prodotti li ġew użati qabel.
Concomitant treatment with molecules displaying action on renal flow (e. g. diuretics) should be subject to clinical monitoring.
L- użu flimkien ma molekuli li jaġixxu fuq il- flussu tal- kliewi (bħal dijuretiċi) għandu jsir taħt monitoraġġ kliniku.
Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.
L- amministrazzjoni fl- istess ħin ta mediċina potenzialment nefrotossika għanda tiġi evitata għaliex jista ’ jkun hemm żieda ta ’ riskju ta ’ tossiċita ’ fil- kliewi.
Administer 0.1 mg firocoxib per kg bodyweight, once daily.
Amministra 0. 1 mg firocoxib għal kull kg ta ’ piż tal- ġisem darba kuljum.
Duration of treatment will be dependent on the response observed, but should not exceed 14 days.
Il- tul tal- kura jiddependi mir- rispons osservat, iżda m’ għandux idum iżjed minn 14- il ġurnata.
To administer EQUIOXX at the dose of 0.1 mg firocoxib/ kg, set the syringe plunger to the appropriate dose division for the horse’ s weight.
Biex tamministra il- EQUIOXX fid- doża ta ’ 0. 1 mg firocoxib/ kg, poġġi l- planġer tas- siringa fuq id - diviżjoni tad- doża għall- piż taż- żiemel.
Each full dose division on the syringe plunger delivers sufficient firocoxib to treat 100 kg body weight.
Kull diviżjoni ta ’ doża sħiħa fuq il- planġer tas- siringa tagħti firocoxib suffiċjenti għall- kura ta ’ 100 kg ta ’ piż tal- ġisem.
The contents of one syringe will treat horses weighing up to 600 kg.
Il- kontenut ta ’ siringa waħda jikkura żwiemel li jiżni sa ’ 600 kg.
To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.
Biex tassigura doża korretta il- piż tal- ġisem għandu jiġi determinat b’ mod preċis kemm jista ’ jkun biex tevita dożi eccessivi.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’ s weight.
Biex tagħti l- firocoxib f’ doża kif suppost, iftaħ l- iskorfina ta ’ mal- planġer tas- siringa billi ddawwarha ¼ ta ’ tidwira u mexxiha tul il- planġer xaft sa ’ d- diviżjoni tad- doża kif suppost għall- piż taz- żiemel.
Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Dawwar l- iskorfina b’ dawra ta ’ ¼ biex tgħalaqha fil- post u kun żgur li hija magħluqa.
Make sure the horse’ s mouth contains no feed.
Kun żgur li m’ hemmx ikel f’ ħalq iż- żiemel.
Remove the cover from the tip of the syringe.
Neħħi l- għatu mill- ftuħ tas- siringa.
Insert the syringe tip into the horse’ s mouth at the interdental space and deposit the paste on the base of the tongue.
Daħħal il- ftuħ tas - siringa f’ ħalq iż- żiemel fl- ispazju ta ’ bejn is- snien u poġġi il- pejst taħt l- ilsien.
3/ 17 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3/ 17 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Lesions (erosion/ ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose.
Leżjonijiet (slieħ/ ulċeri) tal- mukosa orali u tal- ġilda madwar il- ħalq jistgħu jiġu osservati kultant f’ annimali li jkunu qegħdin jingħataw il- kura meta jiġu amministrati id- doża rakkomandata.
Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.
Tipikament, dawn il- leżjonijiet huma ħfief u jmorru mingħajr kura, iżda l- leżjonijiet orali jistgħu ikunu assoċjati mal- formazzjoni tal- bżieq u edema tax- xufftejn u ta ’ l- ilsien.
The incidence of oral/ skin lesions increases with increasing dose.
L- inċidenza tal- leżjonijiet fil- ħalq u fil- ġilda tiżdied meta tiżdied id- doża.
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed.
F’ dożi għolja u kura fit- tul (tliet darbiet iżjed mid- doża irrakkomandata għal 42 jum konsekuttiv u 2. 5 drabi iżjed mid- doża irrikmandata għal 92 jum konsekuttiv amministrata darba kuljum) leżjonijiet ħfief sa moderati fil- kliewi ġew osservati.
If clinical signs occur, treatment should be discontinued and symptomatic treatment initiated.
Jekk ikun hemm sinjali kliniċi, il- kura għanda titwaqqaf u kura sintomatika tinbeda.
26 days Do not use in mares producing milk for human consumption.
26 ġurnata Tużax f’ debba li tipproduċi l- ħalib għall- konsum tal- bniedem.
Pharmacotherapeutic group:
Kodiċi ATĊ veterinarja:
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Il- Firocoxib hija mediċina anti- infjammatorja mhux sterojdi (NSAID) li tappartjeni għall- grupp Coxib li taġixxi b’ inibizzjoni selettiva ta ’ cyclooxygenase- 2 (COX- 2) – sintesi medjata tal- prostaglandin.
Cyclooxygenase is responsible for generation of prostaglandins.
Ic - cyclooxygenase huwa responsabbli biex jifforma il- prostaglandin.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX- 2 hija l- isoforma tal- enżima li ġie muri li tiġi indotta minn stimoli pro- infjammatorji u huwa maħsub li hija primarjament responsabbli għas- sintesi tal- medjaturi prostanojdi ta ’ l- uġigħ, infjammazzjoni u d- deni.
Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties.
Għalhekk il - Coxibs juru kwalitajiet analġesiċi, anti- infjammatorji, u antipiretiċi.
COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception, and cognitive function). “ In “ in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
Fil- provi in - vitro tad- demm sħiħ taż- żiemel, il- firocoxib juri selettivita ’ ta ’ 222 sa ’ 643 darba għal COX- 2 fuq COX- 1.
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i. e., the IC50) is 0.0369 to 0.12 µM, whereas the IC50 for COX-1 is 20.14 to 33.1 µM.
Il- konċentrazzjoni tal- firocoxib neċessarja biex tinibixxi 50% tal- enżima COX- 2 (jigifieri il IC50) hija ta ’ 0. 0369 sa 0. 12 µM,, mentri il IC50 għal COX- 1 hija ta ’ 20. 14 sa ’ 33. 1 µM.
Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 3.9 (± 4.4) hours.
Wara l- amministrazzjoni mill- ħalq liż- żwiemel fid- doża rakkomandata ta ’ 0. 1mg għal kull kg ta ’ piż, il- firocoxib jiġi assorbit malajr u l- ħin għall- konċentrazzjonali massimali (Tmax) huwa ta ’ 3. 9 (± 4. 4) siegħat.
The peak concentration (Cmax) is 0.075 (± 0.033) µg/ ml (equivalent to approximately 0.223 µM), area under the curve (AUC0-24) is 0.96 (± 0.26) µg x hr/ ml, and oral bioavailability is 79 (± 31) percent.
L- għola konċentrazzjoni (Cmax) hija ta ’ 0. 075 (± 0. 33) µg/ ml (ekwivalenti għal bejn wieħed u ieħor 0. 223 µM), l- erja taħt il- kurva (AUC 0- 24) hija 0. 96 (±0. 26) µg hr/ ml u il- biodisponibilita ’ orali hija ta ’ 79 (±31) fil- mija.
The elimination half-life (t½) after a single dose is 29.6 (± 7.5) hours and 50.6 hours after 14 days of dosing.
L- eliminazzjoni half- life (t½) wara doża waħda hija ta ’ 29. 6 (± 7. 5) siegħat u 50. 6 siegħat wara 14- il jum ta ’ dożaġġ.
Firocoxib is approximately 97% bound to plasma proteins.
Il- Firocoxib jeħel approssimattivament 97% mal - proteini tal- plasma.
Following multiple oral administrations, the steady state is reached by approximately the eighth daily dose.
Wara l- amministrazzjoni għal diversi drabi mill- ħalq, l- istat fiss jiġi milħuq wara t- tmien doża ta ’ kuljum.
Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver.
Il- Firocoxib huwa metabolizzat l- aktar bil- dejalkilazzjoni u glukoronidazzjoni fil- fwied.
Elimination is principally in the excreta (primarily the urine), with some biliary excretion also observed.
L- eliminazzjoni hija prinċipalment fil- ħmieġ (primarjament fl- urina), u ġiet osservata ukoll xi ekskreta fil- bile.
Titanium dioxide (E 171) Glycerol triacetate Silica, colloidal anhydrous
Titanium dioxide (E 171) Glycerol triacetate Silica, colloidal anhydrous Magnesium carbonate, tqil Macrogol 300
4/ 17 Magnesium carbonate, heavy Macrogol 300
6. 2 Inkompatibilitajiet
6.2 Incompatibilities
Mhux applikabbli.
Not applicable.
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Shelf life of the veterinary medicinal product as packaged for sale:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
3 years Shelf life after first opening the syringe:
Żmien li l- prodott mediċinali veterinarju jibqa tajjeb wara li tiftah is- siringa:
3 months
3 xhur
Replace cap after use.
Poġġi l- għatu f’ postu wara l- użu.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ta ’ kundizzjonijiet speċjali għal- ħażna.
Pre-filled oral syringes made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Siringi tal- ħalq mimlijin għal- lest tal- polypropylene, bl- għatu tal- polyethylene, rod tip tal- gomma, u planġer rod tal- polypropylene.
Each syringe contains a net weight of 7.32 g of oral paste and is labelled in 100 kg dosing increments.
Kull siringa fiha piż nett ta ’ 7. 32 g ta ’ pejst tal- ħalq u hija. mmarkati b’ linji li kull waħda tindika doża ta ’ 100 kg.
Each syringe is packaged in an individual carton box.
Kull siringa hija ppakkjata f’ kaxxa tal- kartun individwali.
MARKETING AUTHORISATION HOLDER
IS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
MERIAL 29 avenue Tony Garnier FR-69007 Lyon France.
MERIAL 29 avenue Tony Garnier FR- 69007 Lyon, France
25.06.2008
25. 06. 2008 5/ 17 10.
5/ 17 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
6/ 17 ANNEX II
6/ 17 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IS- SID/ 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- UŻU
Merial S. A. S.
Merial S. A. S.
4 Chemin de Calquet 31300 Toulouse France
4 Chemin de Calquet 31300 Toulouse France