qanastek/EMEA-V3 huggingface dataset:
Dosage (mg active substance/ kg)
Dożaġġ (mg tas - sustanza attiva/ kg)
Application in feed Incorporation of 200 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '200 mg ta' sustanza attiva għal kull kilogramm
Treatment &
Pnewmonja enżootika tal - majjali
10 – 12 mg/ kg bodyweight/ day
10 – 12 mg/ kg piż korporali/ kulju m
Swine Enzootic Pneumonia
Econor 10% - 2 g/ kg ta ’ għalf
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.
Infezzjonijiet sekondarji b’ organiżmi bħal Pasteurella multocida u Actinobacillus pleuropneumoniae jistgħu jikkumplikaw il- pnewmonja enżootika u jeħtieġu mediċini speċifiċi.
ADVICE ON CORRECT ADMINISTRATION:
PARIR SABIEX TAMMINISTRA B' MOD KORRETT:
mg Econor 10% premix/ kg feed = Dosage required (mg/ kg) x 10 x bodyweight (kg)/ Daily feed intake (kg)
mg Econor 10% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 10 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
1 part Econor 10% premix to 10 parts feed ingredient.
Il- kwantià ta ’ prodott meħtieġ huwa mħallat tajjeb ma ’ ingredjent ta 'l- għalf ta ’ natura fiżika simili (eż. qmuħ ta ’ kwalità inferjuri) fil- proporzjon: parti 1 Econor 10% taħlita lesta minn qabel ma ’ 10 parti ingredjent ta ’ l- għalf.
35 Shelf life:
36 Żmien ta 'kemm il- prodott idum tajjeb:
5years Shelf-life when incorporated into meal feed and protected from light and moisture:
5 snin Żmien ta 'kemm il- prodott idum tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
36 PACKAGE LEAFLET
37 FULJETT TA 'TAGĦRIF FIL- PAKKETT
Sandoz GmbH Schaftenau Plant A-6336 Langkampfen Austria
Sandoz GmbH Schaftenau Plant A- 6336 Langkampfen L- Awstrija
Econor 50% premix contains valnemulin in the form of valnemulin hydrochloride.
Econor 50% taħlita lesta fih valnemulin f' għamla ta 'valnemulin hydrochloride.
Hypromellose Talc
Lista ta ’ sustanzi mhux attivi Hypromellose u talc
DOSAGE, METHOD AND ROUTE(S) OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
Application in feed
Il- perijodu t' applikazzjoni ta 'għalf immedikat bħala r - razzjon waħdieni ta' kuljum
Incorporation of 75 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '75 mg ta' sustanza attiva għal kull kilogramm
substance per kg feed with:
Diżenterija tal- majjali
to 4 weeks or until signs of disease disappear
3- 4 mg/ kg piż korporali/ kulju m
Econor 50% - 150 mg/ kg feed
Econor 50% - 150 mg/ kg ta ’ għalf
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
39 Dan il- livell ta ’ dożaġġ huwa effettiv fit- trattament ta ’ mard kliniku, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġ għall- eliminazzjoni sħiħa ta ’ l- infezzjoni.
38 Indication
Indikazzjoni Trattament tas- sinjali kliniċi
substance per kg feed with:
3- 4 mg/ kg piż
Econor 50% - 150 mg/ kg
Ġimagħtejn jew sakemm is - Econor 50% - 150 mg/ kg ta ’ għalf
disease disappear
sinjali tal- marda jisparixxu
(mg active substance/ kg)
Dożaġġ (mg tas- sustanza attiva/ kg)
Incorporation of 25 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '25 mg ta' sustanza attiva għal kull
substance per kg feed with:
kilogramm ta ’ għalf ma ':
Econor 50% - 50 mg/ kg
Econor 50% - 50 mg/ kg ta ’ għalf
39 Indication
40 Indikazzjoni Treatment u Prevenzjoni ta '
substance/ kg)
Dożaġġ (mg tas - sustanza attiva/ kg)
Incorporation of 200 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '200 mg ta' sustanza attiva għal kull kilogramm ta ’ għalf ma ':
Treatment &
Pnewmonj
10 – 12 mg/ kg bodyweight/ day
10 – 12 mg/ kg piż
Econor 50% - 400 mg/ kg feed
Econor 50% - 400 mg / kg ta ’ għalf
Swine Enzootic Pneumonia
a enżootika tal- majjali
mg Econor 50% premix/ kg feed = Dosage required (mg/ kg) x 2 x bodyweight (kg)/ Daily feed intake (kg)
mg Econor 50% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 2 x piż korporali (kg) / teħid ta’ għalf kuljum (kg).
To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is required.
Biex tinkiseb taħlita tajba u omoġeneità fl- inkorporazzjoni, l- użu tat- taħlita lesta minn qabel huwa rakkomandat.
40 Shelf life:
Żmien ta 'kemm il- prodott idum tajjeb:
5 years Shelf-life when incorporated into meal feed and protected from light and moisture:
Żmien ta 'kemm il- prodott idum tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
SPECIAL WARNING(S)
TWISSIJIET SPEĊJALI:
41 PACKAGE LEAFLET
42 FULJETT TA 'TAGĦRIF FIL- PAKKETT
Econor 0.5% premix contains valnemulin in the form of valnemulin hydrochloride.
Econor 0. 5% taħlita lesta fih valnemulin f' għamla ta 'valnemulin hydrochloride.
Valnemulin hydrochloride equivalent to valnemulin base
Valnemulin hydrochloride ekwivalenti għal bażi ta 'valnemulin
List of excipients:
5. 325 mg/ g
to 4 weeks or until signs of
3- 4 mg/ kg piż korporali/ kuljum
Econor 0.5% - 15 g/ kg feed
Econor 0. 5% - 15 mg kg ta ’ għalf
43 This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
44 Dan il- livell ta ’ dożaġġ huwa effettiv fit- trattament ta ’ mard kliniku, imma dożaġġi aktar għoljin jew fuq tul ta ’ żmien itwal tat- trattament jistgħu jkunu meħtieġ għall- eliminazzjoni sħiħa ta ’ l- infezzjoni.
Indication
Indikazzjoni Trattament tas- sinjali kliniċi
Econor 0.5% - 15 g/ kg feed
Econor 0. 5% - 15 mg / kg ta ’ għalf
Porcine
ja
3-4 mg/ kg
Enteropati
2 weeks or until signs of
3- 4 mg/ kg piż korporali/ kuljum
Proliferative Enteropathy (ileitis)
Ġimagħtejn jew sakemm is - sinjali tal- marda jisparixxu
disease disappear
Proliferattiva tal- Majjali (ileitis)
It is important to institute medication as early as possible in an outbreak of porcine proliferative enteropathy.
Huwa importanti li tagħti l- mediċina kemm jista ’ jkun kmieni possibbli f’ imxija ta ’ enteropatija proliferattiva tal- majjali.
(mg active substance/ kg)
Dożaġġ (mg ta 'sustanza attiva/ kg)
Incorporation of 25 mg active
Applikazzjoni fl- għalf Inkorporazzjoni ta '25 mg ta' sustanza attiva għal kull kilogramm
Prevention of
Diżenterija
minimum of 7 days and
ta ’ għalf ma ':
substance per kg feed with:
tal- majjali
Swine
1. 0 – 1. 5 mg/ kg piż
up to 4 weeks
minimu ta '7t ijiem u sa 4 ġimgħat
Econor 0.5% - 5 g/ kg feed
Econor 0. 5% - 5 mg / kg ta ’ għalf
Dysentery Clinical signs of Porcine Colonic Spirochaetosis (colitis)
Sinjali kliniċi ta ’ Spirochaetosi s kolonika (kolité) tal - majjali
4 weeks
4 ġimgħat
Mixing Instructions: mg Econor 0.5% premix/ kg feed = Dosage required (mg/ kg) x 200 x bodyweight (kg) / Daily feed intake (kg)
Struzzjonijiet dwar it- taħlit: mg Econor 0. 5% taħlita lesta minn qabel/ kg ta ’ għalf = Dożaġġ meħtieġ (mg/ kg) x 200 x piż korporali (kg) / teħid ta ’ għalf kuljum (kg).
Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Għandha tingħata kunsiderazzjoni għall- gwida uffiċjali dwar l- inkorporazzjoni ta ’ taħlitiet medikati ppreparati minn qabel, fl- għalf finali.
3 years Shelf-life when incorporated into meal feed and protected from light and moisture:
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jiġi miżjud ma ’ l- ikel u protett mid- dawl u l- umdità:
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during pregnancy and lactation has not been established in pigs.
Filwaqt li studji fil- firien u l- ġrieden ma pproduċew l- ebda xhieda ta ’ effett teratoġeniku, is- sigurtà fil - majjali waqt it- taqla u l- irdigħ għadha ma ġietx stabbilita.
45 13.
46 13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
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- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tal- annimal tiegħek ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar - rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Equilis Prequenza Te?
X’ inhu Equilis Prequenza Te?
Equilis Prequenza Te is a vaccine for use in horses.
Equilis Prequenza Te huwa vaċċin għall- użu fiż- żwiemel.
It contains parts (subunits) of three equine influenza (flu) strains (‘ A/ equine-1/ Prague/ 1/ 56’, ‘ A/ equine-2/ Newmarket/ 1/ 93’ and ‘ A/ equine- 2/ Newmarket/ 2/ 93’) and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium).
Fih partijiet (subunitajiet,) ta ’ tliet razez tal- influwenza ekwina (‘ A/ equine- 1/ Prague/ 1/ 56 ’, ‘ A/ equine- 2/ Newmarket/ 1/ 93 ’ u ‘ A/ equine- 2/ Newmarket/ 2/ 93 ’) u tossojde tat- tetnu (tossin inattivat kimikament mill- batterju tat- tetnu).
The vaccine is available as a suspension for injection.
Il- vaċċin jiġi bħala sospensjoni għall- injezzjoni.
What is Equilis Prequenza Te used for?
Għal xiex jintuża Equilis Prequenza Te?
Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus.
Equilis Prequenza Te jintuża fit- tilqim taż- żwiemel mill- età ta ’ sitt xhur kontra l- influwenza ekwina u t- tetnu.
The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Il- vaċċin inaqqas is- sinjali tal- influwenza ekwina u l- eskrezzjoni (tnixxija) tal - virus wara l- infezzjoni.
Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
L- influwenza ekwina hija marda li tittieħed faċilment ħafna li hi komuni ħafna fiż- żwiemel iżda li rari tikkawża l- mewt.
The vaccine also stimulates protection against tetanus to prevent mortality.
Il- vaċċin jistimula wkoll il- protezzjoni kontra t- tetnu biex inaqqas il- mortalità.
Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani.
It- tetnu hija marda akuta, ħafna drabi fatali kkawżata min- newrotossin tal- 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.
Horses belong to the most susceptible species to tetanus.
Iż- żwiemel jagħmlu parti mill- iktar speċi suxxettibbli għat- tetnu.
The vaccine is given as an injection into a muscle.
Il- vaċċin jingħata bħala injezzjoni f’ muskolu.
Horses should receive a primary vaccination, consisting of two injections given four weeks apart.
Iż- żwiemel għandhom jingħataw tilqima primarja, li tikkonsisti minn żewġ injezzjonijiet b’ erba ’ ġimgħat bejniethom.
To retain protection, horses need to be revaccinated.
Biex tinżamm il- protezzjoni, iż- żwiemel ikunu jridu jitlaqqmu mill- ġdid.
For protection against equine influenza, the first revaccination should be five months after primary vaccination, followed by yearly revaccinations.
Għall- protezzjoni kontra l- influwenza ekwina, it- tieni tilqima tkun trid issir ħames xhur wara l - ewwel tilqima, u mbagħad tkun trid tingħata tilqima oħra kull sena.
For protection against tetanus, the first revaccination should be no later than 17 months after primary vaccination.
Għall- protezzjoni kontra t - tetnu, it- tieni tilqima tkun trid tingħata mhux iktar minn 17- il xahar wara l- ewwel tilqima.
Afterwards, a maximum interval of two years is recommended.
Wara dan, huwa rakkomandat intervall massimu ta ’ sentejn.
How does Equilis Prequenza Te work?
Kif jaħdem Equilis Prequenza Te?
Equilis Prequenza Te contains fragments (subunits) of the influenza viruses against which the vaccine is indicated for.
Equilis Prequenza Te jikkonsisti minn frak (subunitajiet) tal- vajrusijiet tal- influwenza li hu indikat kontrihom il- vaċċin.
These fragments provoke a protective response of the immune system (the body ’ s natural defences) but cannot cause the disease.
Dan il- frak jipprovoka rispons protettiv tas- sistema immunitarja (id- difiża naturali tal- ġisem) iżda ma jistax jikkawża l- marda.
The vaccine also contains purified tetanus toxoid.
Il- vaċċin fih ukoll tossojde tat -
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tetnu ppurifikat.
Vaccines work by ‘ teaching’ the immune system how to defend itself against diseases.
Il- vaċċini ‘ jgħallmu ’ lis- sistema immunitarja kif tiddefendi ruħha mill- mard.
When the product is given to horses, it helps the animals’ immune system to react quicker when the animal is naturally exposed to the equine influenza virus and the Clostridium tetani bacterium.
Meta l- prodott jingħata liż- żwiemel, dan jgħin lis- sistema immunitarja tirreaġixxi iktar malajr meta l- annimal jiġi espost b’ mod naturali għall- virus tal- influwenza ekwina u l- batterju Clostridium tetani.
This helps to protect against equine influenza and tetanus.
Dan jgħin fil- protezzjoni kontra l- influwenza ekwina u t- tetnu.
The vaccine also contains an ‘ adjuvant’ to stimulate a better immune response.
Il- vaċċin fih ukoll ‘ aġġuvant ’ biex jistimula rispons immuni aħjar.
How has Equilis Prequenza Te been studied?
Kif ġie studjat Equilis Prequenza Te?
The safety of Equilis Prequenza 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 Prequenza Te ġiet studjata f’ diversi studji f’ kundizzjonijiet tal- laboratorju u f’ kundizzjonijiet prattiċi f’ għadd kbir ta ’ żwiemel, mill- età ta ’ xahrejn.
It was concluded that the product is well tolerated by horses of different ages.
Ġie konkluż li l - prodott huwa ttollerat tajjeb miż- żwiemel ta ’ etajiet differenti.
Equilis Prequenza Te was also studied in pregnant mares.
Equilis Prequenza Te ġie studjat ukoll f’ 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 Prequenza Te has been studied in several trials under laboratory and field conditions.
L- effikaċja ta ’ Equilis Prequenza Te ġiet studjata f’ diversi provi taħt kundizzjonjiet tal - laboratorju jew prattiċi.
For ethical reasons no challenge (infection) experiment was performed against tetanus.
Għal raġunijiet etiċi, ma sar l- ebda esperiment bi sfida (infezzjoni) kontra t- tetnu.
The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components.
Il- miżura ewlenija tal- kejl tal- effikaċja ta ’ Equilis Prequenza Te kontra l - influwenza ekwina kienet il- produzzjoni ta ’ livelli protettivi ta ’ antikorpi kontra l- komponenti tal- influwenza.
The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, (i. e. which did not receive the vaccine or received a competitive product).
L- istudji qabblu wkoll is- sinjali kliniċi u l- eskrezzjoni tal- virus ta ’ grupp ta ’ annimali mlaqqma ma ’ dawk ta ’ grupp ta ’ kontroll (jiġifieri li ma kinux ingħataw it- tilqima jew li jkunu ngħataw prodott kompetittiv).
Regarding tetanus, the main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid.
Fir- rigward tat- tetnu, il- mezz ewlieni tal- kejl tal- effikaċja kien il- produzzjoni ta ’ livelli protettivi ta ’ antikorpi kontra t- tossojde tat- tetnu.
What benefit has Equilis Prequenza Te shown during the studies?
Liema benefiċċju ta ’ Equilis Prequenza Te ntwera f’ dawn l- istudji?
The studies showed that Equilis Prequenza Te is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality, in horses from 6 months of age.
L- istudji wrew li Equilis Prequenza Te huwa tilqima effettiva kontra l- influwenza ekwina biex tnaqqas is- sinjali kliniċi u l- eskrezzjoni tal- virus wara l- infezzjoni, u kontra t- tetnu biex jimpedixxi l- mortalità, fiż- żwiemel li jkollhom sitt xhur u aktar.
Horses developed protective levels of antibodies two weeks after primary vaccination.
Iż- żwiemel żviluppaw livelli protettivi ta ’ antikorpi ġimagħtejn wara t- tilqima primarja.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus.
Il- protezzjoni ddum ħames xhur wara l- ewwel tilqima u 12- il xahar wara t- tieni tilqima għall- influwenza ekwina u 17- il xahar wara l- ewwel tilqima u 24 xahar wara t- tieni tilqima għat- tetnu.
What is the risk associated with Equilis Prequenza Te?
X’ riskji huma assoċjati ma ’ Equilis Prequenza Te?
Swelling (max. diameter 5 cm) may occur at the injection site, either as a 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.
The swelling is expected to decrease within two days.
In- nefħa hija mistennija li tonqos fi żmien jumejn.
Pain at the injection site can occur occasionally.
Xi drabi jista ’ jkun hemm uġigħ fis- sit tal- injezzjoni.
In some cases fever may occur for one day, and up to three days in exceptional circumstances.
F’ xi każijiet jista ’ jkun hemm deni għal jum wieħed, li jdum sa tlitt ijiem f’ ċirkustanzi eċċezzjonali.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Xi prekawzjonijiet trid tieħu l- persuna li tagħti din il- mediċina jew li tiġi f’ kuntatt mal - annimal?
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Fil- każ li titniggeż aċċidentalment, kellem tabib minnufih u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi ħin qabel ma l- annimal ikun jista ’ jinqatel u l- laħam jintuża għall- konsum mill- bniedem (perjodu ta ’ rtirar)?
The withdrawal period of the product is zero days.
Il- perjodu ta ’ rtirar huwa ta ’ żero ġranet.
What is the time to allow before milk can be taken from the animal for human consumption?
Paġna 2/ 3 ©EMEA 2008 Kemm irid jgħaddi żmien qabel ma l- ħalib ikun jista ’ jittieħed mill- annimal għall- konsum mill - bniedem?
Zero days.
Żero ġranet.
Page 2/ 3 ©EMEA 2008 Why has Equilis Prequenza Te been approved?
Għaliex ġie approvat Equilis Prequenza Te?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection and against tetanus to prevent mortality.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Equilis Prequenza Te huma ikbar mir- riskji tiegħu għat- tilqim ta ’ żwiemel mill- età ta ’ sitt xhur kontra l- influwenza ekwina biex inaqqas is- sinjali kliniċi u l- eskrezzjoni tal- virus wara l - infezzjoni u kontra t- tetnu biex jipprevjeni l- mortalità.
The Committee recommended that Equilis Prequenza Te should be given a marketing authorisation.
Il- Kumitat irrakkomanda li Equilis Prequenza Te jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r - riskju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Equilis Prequenza Te:
Tagħrif ieħor dwar Equilis Prequenza Te:
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza 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 Prequenza 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.
This summary was last updated in October 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Page 3/ 3 ©EMEA 2008
Paġna 3/ 3 ©EMEA 2008
Equilis Prequenza Te, suspension for injection, for horses
Equilis Prequenza Te, suspensjoni għall- injezzjoni, għaż- żwiemel
Per dose of 1 ml:
Doża kull 1 ml
Active substances Tetanus toxoid and purified haemagglutinin subunits from equine influenza viruses:
Toksojd tat– tetnu u sub- partjiet purifikati ta ’ ħemoglutinina mill- virus tal- influwenza taż- żwiemel:
A/ equine-1/ Prague/ 1/ 56 A/ equine-2/ Newmarket/ 1/ 93 A/ equine-2/ Newmarket/ 2/ 93 Tetanus toxoid
100 AU1 A/ equine- 1 / Prague/ 1/ 56 A/ equine- 2 / Newmarket/ 1/ 93 A/ equine- 2 / Newmarket/ 2/ 93 Tetanus Toksojd
Adjuvant
Sustanzi mhux attivi
Purified Saponin Cholesterol Phosphatidylcholine
Saponin purifikat Kolesterol Fosfatidilkolin
Excipient Thiomersal traces Formaldehyde traces
Ingredjenti oħra Traċċi ta ’ Tajomersal Traċċi ta ’ formalina
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Immunizzazzjoni attiva għal żwiemel minn sitt xhur il- fuq, kontra l- influwenza taż- żwiemel, biex tnaqqas is- sintomi kliniċi u l- eskrezzjoni tal - virus wara l- infezzjoni, u immunizzazzjoni kontra t- tetnu biex tipprevjeni l- imwiet.
Influenza Onset of immunity:
Influwenza Bidu Kemm
Duration of immunity:
ta ’ l- immunita: iddum l- immunita:
Tetanus
12 - il
2 weeks after the primary vaccination course 5 months after the primary vaccination course 12 months after the first revaccination
2 ġimgħat wara l- ewwel kors ta ’ tilqim 5 xhur wara l- ewwel kors ta ’ tilqim xahar wara l- ewwel rivaċċinazzjoni
Onset of immunity:
2 ġimgħat wara l- ewwel kors ta tilqim
Duration of immunity:
Kemm iddum l- immunita:
2 weeks after the primary vaccination course 17 months after the primary vaccination course 24 months after the first revaccination
24 xahar wara l- ewwel rivaċċinazzjoni
2/ 17 4.3 Contraindications
4. 3 Kontra indikazzjonijiet
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 tlaqmmu għat- tieni darba fl- aħħar xahrejn ta ’ tqala, għax hemm il- possibilita li jinterferixxi ma l - antikorpi ta ’ l- omm.
Only healthy animals should be vaccinated.
Annimali b saħħithom biss għandhom jiġu mlaqqma.
Special precautions to be taken by the person administering the medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In case of accidental self-injection, seek medical advice immediately and show the 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.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
5 cm) jistgħu jfeġġu fil- post tal- injezzjoni, li jonqsu fi żmien jumejn.
Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Jista ’ jkun hemm uġiegħ fil- post ta ’ l- injezzjoni li f’ każijiet rari twassal għal nuqqas temporanju ta ’ funzjoni (ebusija).
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
F ’ każijiet rari ħafna jista ’ jkun hemm deni, akkumpanjat b’ telqa u nuqqas t’ aptit għal ġurnata u f’ ċirkustanzi eċċezjonali ġieli jdum għal tlett ijiem
Can be used during pregnancy and lactation.
Jista 'jintuża waqt it- tqala u żmien il- ħalib.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other vaccine.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe tilqima oħra.
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Is- sigurta u l- effikaċja ġew murija meta l- prodott ingħata fl- istess waqt ma Tetanus- Serum minn Intervet, (ara sezzjoni 4. 9) Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fl- istess ħin jew flimkien ma dan il- prodott.
Intramuscular use
Għall - użu intramuskolari.
Vaccination schedule:
Skeda għat- tilqim
Primary vaccination course
L- ewwel kors ta tilqim Agħti doża waħda (1 ml) fil- muskolu, skond din l- iskema:
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
•
3/ 17 Revaccination Influenza
L- ewwel kors ta tilqim: l- ewwel injezzjoni wara 6 xhur mit- twelid u tieni waħda 4 ġimgħat wara.
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course.
Rivaċċinazzjoni Influwenza L- ewwel rivaċċinazzjoni (t- tielet doża) kontra l- influwenza taż- żwiemel tingħata wara 5 xhur wara li jkun spiċċa l- ewwel kors.
This revaccination results in immunity to equine influenza lasting at least 12 months.
B din it- tilqima l- immunita kontra l - influwenza taż- żwiemel iddum tal - anqas għal 12- il xahar.
The second revaccination is given 12 months after the first revaccination.
It - tieni rivaċċinazzjoni tingħata wara 12- il xahar mill- ewwel rivaċċinazzjoni.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/ equi 1/ Prague 56, A/ equi 2/ Newmarket-1/ 93 and A/ equi 2/ Newmarket-2/ 93, is recommended to maintain immunity levels for the influenza component (see scheme).
(ara skema).
Tetanus The first revaccination is given not later than 17 months after the primary vaccination course.
Tetnu L- ewwel revaċċinazzjoni tingħata mhux aktar tard minn 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 ta ’ sentejn huwa rakkomandat (ara skema).
V1
t6 T1 0
V2
T2 1
12
T3 6
V6
12
18
T4 12 18
30
T5 30
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 ’ kas ta ’ riskju akbar ta ’ infezzjoni jew nuqqas ta ’ teħid ta ’ kolostrum, tilqima addizjonali tista ’ ting] ata fir- raba xahar segwita bil programm komplut ta vaċċinazzjoni (l- ewwel kors ta ’ tilqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
Concurrent active and passive immunisation (emergency vaccination) 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- kas, 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.
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Dan iwassal għall- protezzjoni passiva kontra t- tetnu għal tal- anqas 21 ġurnata wara li jkunu ngħataw is- sirum u t- tilqima flimkien.
The second dose of the vaccine (V2) should be administered 4 weeks later.
It- tieni doża tal- vaċċin (T2) għandha tingħata 4 ġimgħat wara.
A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
It- tielet tilqima bl - Equilis Prequenza Te g] andha terġa ’ tingħata tal- inqas 4 ġimgħat wara.
Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
L - użu flimkien ta ’ Equilis Prequenza Te u Tetanus- Serum tal- Intervet jista ’ jnaqqas l- immunita attiva kontra t- tetnu meta mqabbla ma żwiemel oħra mlaqqma bl - Equilis Prequenza Te biss (mingħajr l- antitoksin tas- sirum tat- tetnu).
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 effett mhux mixtieq, apparti dawk deskritti f parti 4. 6 ma gie osservat xejn ħlief għal ftit sintomi ta ’ dipressjoni fil - jum tal - vaċċinazzjoni.
Zero days
Xejn.
IMMUNOLOGICAL PROPERTIES
KWALITAJIET FARMAKOLOĠIĊI IMMUNOLOĠIĊI
To stimulate active immunity against Equine influenza and tetanus ATC-vet code:
Biex tistimula immunita attiva kontra l- influwenza taż- żwiemel u t- tetnu.
Purified Saponin, Cholesterol, Phosphatidylcholine, Thiomersal traces, Formaldehyde traces
Saponin purifikat, kolesterol, Fosfatidilkolin, traċċi ta Tajomersal, traċċi ta formalina.
4/ 17 6.2 Incompatibilities
4/ 17 6. 2 Inkompatibilitajiet
Do not mix with any other vaccine or immunological product.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
Store at 2-8°C, protected from light.
Aħżen fil- friġġ (2°C – 8°C), Ipproteġi mid- dawl.
Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Vjal 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 magħluq b’ tapp tal- gomma.
Package size:
Daqs tal- pakketti:
Cardboard box with 10 glass vials of 1 ml.
Kaxxa tal - kartun b ’ 10 fjali tal- ħġieġ ta ’ 1 ml.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Kaxxa( i) tal - kartun b ’ 1, 5 jew 10 siringi tal- ħġieġ bil- labar, mimlija għall- lest.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL- 5831 AN Boxmeer The Netherlands
5/ 17 ANNEX II
5/ 17 ANNESS II
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
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL - PROVISTA JEW L- UŻU
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) 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 manufacturers of the biological active substances
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
45 Poplar Road Parkville VIC 3052 Australia
45 Poplar Road Parkville VIC 3052 Australja
Poligono El Montalvo 37080 Salamanca Spain
Poligono El Montalvo 37080 Salamanca Spanja
Veterinary medicinal product subject to prescription.
Jiġu mogħtija biss bi preskrizzjoni veterinarja.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Council Regulation (EEC) 2377/ 90.
Is- sustanza attiva hija parti bioloġika intenzjonata li tipproduċi immunita attiva, u għaldaqstant ma taqax taħt ir- Regolament tal- Kunsill (EEC) 2377/ 90.
The MRL status of the excipients is as follows:
Kummenti
MRL status Annex II for all food producing species (under Quillaia saponins)
Anness II għall- ispeċi kollha li jittieklu (taħt Quillaia saponins)
Comments Commission Regulation (EEC) No 1433/ 96
Regoli tal- kummissjoni (EEC) No 1433/ 96
Sodium phosphate (Na2HPO4)
Fosfat tas- sodjum (Na2HPO4)
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)
Commission Regulation (EEC) No 2034/ 96
Regoli tal- kummissjoni (EEC) No 2034/ 96
Potassium phosphate (KH2PO4)
Fosfat tal- potassjum (KH2PO4)
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)
Sodium chloride (NaCl)
Klorid tas- sodjum (NaCl)
Annex II for all food producing species
Anness II għall- ispeċi kollha li jiitieklu
Commission Regulation (EEC) No 2796/ 95
Regoli tal- kummissjoni (EEC) No 2796/ 95
Magnesium chloride (MgCl2) Calcium chloride (CaCl2)
Klorid tal- Magneżju (MgCl2)
Annex II for all food producing species Annex II for all food producing species
Anness II għall- ispeċi kollha li jittieklu
Commission Regulation (EEC) No 2796/ 95 Commission Regulation (EEC) No 1102/ 95
Regoli tal- kummissjoni (EEC) No 1102/ 95
7/ 17 ANNEX III
7/ 17 ANNESS III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Per dose of 1 ml:
Doża ta 1 ml:
A/ equine-1/ Prague 56 (100 AU), A/ equine-2/ Newmarket/ 1/ 93 (50 AU), A/ equine-2/ Newmarket/ 2/ 93 (50 AU), Tetanus toxoid 40 Lf.
A/ equine- 1Prague 56 (100AU), A/ equine- 2/ Newmarket/ 1/ 93 (50 AU), A/ equine 2/ Newmarket/ 2/ 93 (50AU), Tetanus Toksojd 40 Lf
1, 5 or 10 50 x 1 dose
1, 5 jew 10 x 1 doża
Active immunisation of horses against equine influenza and tetanus
Immunita attiva għaż- żwiemel kontra l- influwenza taż- żwiemel u t- tetnu.
i. m. use
Għall- użu intramuskolari
Zero days
xejn ġranet.
Store at 2-8 °C, protected from light.
Aħżen fil- friġġ (2°C – 8°C), Ipproteġi mid- dawl.
Do not freeze.
Tiffriżax
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 KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only Veterinary medicinal product subject to prescription
Għal Trattament ta ’ l- Annimali Biss Għandu jingħata biss b’ riċetta veterinarja.
THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
MANUFACTURER'S BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
< Batch > < Lot > < BN > {number}
Lott Nru.
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
i. m.
Għall- użu intramuskolari
{batch no.}
Lot {numru}
{month/ year}
Exp {xahar/ sena}
13/ 17 PACKAGE LEAFLET FOR:
13/ 17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Equilis Prequenza Te, suspension for injection, for horses
Equilis Prequenza, suspensjoni għall- injezzjoni, għaż- żwiemel
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
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
A/ equine-1/ Prague/ 1/ 56 A/ equine-2/ Newmarket/ 1/ 93 A/ equine-2/ Newmarket/ 2/ 93 Tetanus toxoid
100 AU3 A/ equine- 1 / Prague/ 1/ 56 A/ equine- 2 / Newmarket/ 1/ 93 A/ equine- 2 / Newmarket/ 2/ 93 Tetanus Toksojd
AU3 AU AU Lf4
Sustanzi mhux attivi
Purified saponin Cholesterol Phosphatidylcholine
Saponin purifikat Kolesterol Fosfatidilkolin
INDICATION(S)
Indikazzjonijiet
Influenza Onset of immunity:
2 ġimgħat wara l- ewwel kors ta tilqim
2 weeks after the primary vaccination course 5 months after the primary vaccination course 12 months after the first revaccination
5 xhur wara l- ewwel kors ta tilqim xahar wara l- ewwel revaċċinazzjoni
Tetanus
Tetnu
Onset of immunity:
Bidu ta immunita:
2 weeks after the primary vaccination course
2 ġimgħat wara l- ewwel kors ta tilqim
3 Antigenic units 4 Flocculation equivalents; corresponds with ≥ 30 IU/ ml guinea pig serum in the Ph. Eur. potency test
Kemm iddum l- immunita:
14/ 17 Duration of immunity:
17- il xahar wara l- ewwel kors ta tilqim
17 months after the primary vaccination course 24 months after the first revaccination
24 xahar wara l- ewwel rivaċċinazzjoni
CONTRAINDICATIONS
KUNTRAINDIKAZZJONIJIET
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
5 cm) jistg] u jfeġġu fil- post tal- injezzjoni, li jonqsu fi żmien jumejn.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
F ’ każijiet rari ħafna jista ’ jkun hemm deni, akkumpanjat b’ letarġija u nuqqas t’ aptit għal ġurnata u f’ ċirkustanzi eċċezjonali ġieli jdum sa tlett ijiem
Intramuscular use
1 ml fil- muskolu.
Vaccination schedule:
Skeda g] at- 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 tieni waħda 4 ġimgħat wara.
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course.
Rivaċċinazzjoni Influwenza L- ewwel rivaċċinazzjoni (t- tielet doża) kontra l- influwenza taż- zwiemel tingħata wara 5 xhur wara li jkun spiċċa l- ewwel kors.
This revaccination results in immunity to equine influenza lasting at least 12 months.
B din it- tilqima l- immunita kontra l - influwenza taż- zwiemel iddum tal - anqas għal 12- il xahar.
The second revaccination is given 12 months after the first revaccination.
It - tieni rivaċċinazzjoni ting] ata wara 12- il xahar mill- ewwel rivaċċinazzjoni.
Tetanus The first revaccination is given not later than 17 months after the primary vaccination course.
Tetnu L- ewwel revaċċinazzjoni ting] ata mhux aktar tard minn 17- il xahar wara l- ewwel kors vaċċinazzjoni.
V1 0
15/ 17 t6 T1 0
V2 1
T2 1
V3 6
T3 6
V4 12 18
T4 12 18
V5 12 30
T5 30
V6 42 months
42 xahar
15/ 17 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 ’ kas 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 ’ tilqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
Concurrent active and passive immunisation (emergency vaccination) 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 jing] ata ma Tetanus- Serum tal- Intervet lil żwiemel midruba li mhumiex imlaqqma kontra t- tetnu.
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Dan iwassal g] all- protezzjoni passiva kontra t- tetnu għal tal- anqas 21 ġurnata wara li jkunu ngħataw is- sirum u t- tilqima flimkien.
A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
It- tielet tilqima bl - Equilis Prequenza Te għandha terġa ’ tingħata tal- inqas 4 ġimgħat wara.
Allow the vaccine to reach room temperature (15-25°C) before use.
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 intramuskolari.
Safety and efficacy of concurrent use with Tetanus-Serum from Intervet has been demonstrated.
Is- sigurta u l- effikaċja ġew murija meta l- prodott ingħata fl- istess waqt ma Tetanus- Serum minn Intervet.
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra fl- istess ħin jew flimkien ma dan il- prodott.
Do not freeze.
Tifriżax.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta l- iskadenza li hemm fuq it- tikketta.
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 -
Do not mix with any other vaccine or immunological product.
Tħallatx ma vaċċini oħra jew prodotti immunoloġiċi.
Cardboard box with 10 glass vials of 1 ml.
Kaxxa tal - kartun b 10 fjali tal- ħġieġ ta 1 ml.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Kaxxa( i) tal - kartun b ’ 1, 5 jew 10 siringi tal- ħġieġ, bil- labar, mimlija għal- lest.
What is Equilis Prequenza?
X’ inhu Equilis Prequenza?
Equilis Prequenza is a vaccine for use in horses.
Equilis Prequenza huwa vaċċin għall- użu fiż- żwiemel.
It contains parts (subunits) of three equine influenza (flu) strains (‘ A/ equine-1/ Prague/ 1/ 56’, ‘ A/ equine-2/ Newmarket/ 1/ 93’ and ‘ A/ equine- 2/ Newmarket/ 2/ 93’).
Fih partijiet (subunitajiet,) ta ’ tliet razez tal- influwenza ekwina (‘ A/ equine- 1/ Prague/ 1/ 56 ’, ‘ A/ equine- 2/ Newmarket/ 1/ 93 ’ u ‘ A/ equine - 2/ Newmarket/ 2/ 93 ’).
What is Equilis Prequenza used for?
Għal xiex jintuża Equilis Prequenza?
Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza.
Equilis Prequenza jintuża fit- tilqim taż- żwiemel mill- età ta ’ sitt xhur kontra l- influwenza ekwina.
Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
L- influwenza ekwina hija marda li tittieħed faċilment li hi komuni ħafna fiż- żwiemel iżda li rari tikkawża l- mewt.
The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Il- vaċċin inaqqas is- sinjali tal- influwenza ekwina u l- eskrezzjoni (tnixxija) tal- vajrus wara l- infezzjoni.
This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.
Dan għandu jiġi segwit bit- tielet tilqima ħames xhur wara, u minn hemm ’ il quddiem b’ tilqim mill- ġdid ta ’ kull sena.
How does Equilis Prequenza work?
Kif jaħdem Equilis Prequenza?
Equilis Prequenza contains fragments (subunits) of the influenza virus against which the vaccine is indicated for.
Equilis Prequenza jikkonsisti minn frak (subunitajiet) tal- vajrus tal- influwenza li hu indikat kontrih il- vaċċin.
When the product is given to horses, it helps the animals’ immune system to react more quickly when the animal is naturally exposed to the virus.
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- vajrus.
This helps to protect against equine influenza.
Dan jgħin fil- protezzjoni kontra l- influwenza ekwina.
The vaccine also contains an ‘ adjuvant’ to stimulate a better response.
Il- vaċċin fih ukoll ‘ adjuvant ’ biex jistimula rispons aħjar.
How has Equilis Prequenza been studied?
Kif ġie studjat Equilis Prequenza?
The safety of Equilis Prequenza 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 Prequenza ġiet studjata f’ diversi studji f’ kundizzjonijiet tal- laboratorju u f’ kundizzjonijiet prattiċi f’ għadd kbir ta ’ żwiemel, mill- età ta ’ xahrejn.
It was concluded that the product is well tolerated by horses of different ages.
Ġie konkluż li l- prodott huwa ttollerat tajjeb miż- żwiemel ta ’ etajiet differenti.
Equilis Prequenza was also studied in pregnant mares.
Equilis Prequenza ġie studjat ukoll f’ debbiet tqal.
The effectiveness of Equilis Prequenza has been studied in several trials under laboratory and field conditions.
L- effikaċja ta ’ Equilis Prequenza ġiet studjata f’ diversi provi taħt kundizzjonjiet tal- laboratorju jew prattiċi.
Most of the studies used Equilis Prequenza Te, a vaccine that protects against the three equine influenza strains (the same as Equilis Prequenza), as well as tetanus.
Ħafna mill- istudji użaw Equilis Prequenza, tilqima li tipproteġi kontra t- tliet razez ta ’ influwenza ekwina (l- istess bħal Equilis Prequenza), kif ukoll kontra t- tetnu.
The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Il- kejl ewlieni tal- effikaċja kien il- produzzjoni ta ’ livelli protettivi ta ’ antikorpi kontra l- komponenti tal - influwenza.
The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, i. e. which did not receive the vaccine.
L- istudji qabblu wkoll is- sinjali kliniċi u l- eskrezzjoni tal- vajrus ta ’ grupp ta ’ annimali mlaqqma ma ’ dawk ta ’ grupp ta ’ kontroll, jiġifieri li ma kinux ingħataw it- tilqima.
What benefit has Equilis Prequenza shown during the studies?
Liema benefiċċju ta ’ Equilis Prequenza ntwera f’ dawn l- istudji?
The studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
L- istudji wrew li Equilis Prequenza huwa tilqima effettiva kontra l- influwenza ekwina biex tnaqqas is- sinjali kliniċi u l- eskrezzjoni tal- vajrus wara l- infezzjoni fiż- żwiemel li jkollhom sitt xhur u aktar.
Horses developed protection two weeks after primary vaccination.
Iż- żwiemel żviluppaw protezzjoni ġimagħtejn wara t- tilqima primarja.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination.
Il - protezzjoni damet ħames xhur wara l- ewwel tilqima u 12- il xahar wara t- tieni tilqima.
What is the risk associated with Equilis Prequenza?
X’ riskji huma assoċjati ma ’ Equilis Prequenza?
Swelling (max. diameter 5 cm) may occur, either as hard or soft swelling.
Jista ’ jkun hemm nefħa iebsa jew ratba (b’ dijametru ta ’ mhux iktar minn 5 ċm).
In some cases fever may occur for one day, and up to three days in exceptional circumstances.
F’ xi każijiet jista ’ jkun hemm deni għal jum wieħed, li jdum sa tlett ijiem f’ ċirkustanzi eċċezzjonali.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm irid jgħaddi żmien qabel ma l- ħalib ikun jista ’ jittieħed mill- annimal għall- konsum mill - bniedem?
Why has Equilis Prequenza been approved?
Għaliex ġie approvat Equilis Prequenza?