qanastek/EMEA-V3 huggingface dataset:
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza 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.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Equilis Prequenza 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- vajrus wara l - infezzjoni.
The Committee recommended that Equilis Prequenza should be given a marketing authorisation.
Il- Kumitat irrakkomanda li Equilis Prequenza jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Page 2/ 3 ©EMEA 2008 Other information about Equilis Prequenza:
Paġna 2/ 3 ©EMEA 2008 Tagħrif ieħor dwar Equilis Prequenza:
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza 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 lil Intervet International BV fit- 8 ta ’ Lulju 2005.
Equilis Prequenza, suspension for injection, for horses
Equilis Prequenza, suspensjoni għall- injezzjoni, għaż- żwiemel
Active substances Purified haemagglutinin subunits from equine influenza viruses:
Sub- partijiet 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
100 AU1 A/ equine- 1 / Prague/ 1/ 56 A/ equine- 2 / Newmarket/ 1/ 93 A/ equine- 2 / Newmarket/ 2/ 93 1:
Excipient Thiomersal traces
Ingredjenti oħra
For full list of excipients, see section 6.1.
Traċċi ta ’ Tajomersal
PHARMACEUTICAL FORM
Għall- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Suspension for injection
GĦAMLA FARMAĊEWTIKA Suspensjoni għall- injezzjoni
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Immunizzazzjoni attiva għal żwiemel ta ’ aktar minn sitt xhur, kontra l- influwenza taż- żwiemel, biex tnaqqas is- sintomi klini`i u tnaqqis ta ’ eskrezzjoni tal - virus, wara l- infezzjoni.
Influenza Onset of Duration
Influwenza Bidu ta ’ immunita:
immunity: of immunity:
Kemm iddum l- immunita:
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
Contraindications
4. 3 Kontra indikazzjonijiet
2/ 16 4.4 Special warnings
2/ 16 4. 4 Twissijiet speċjali
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 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.
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.
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- effiċjenza ta ’’ din it- tilqima jekk tintuża flimkien ma tilqima oħra.
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 li tlaqqam b' dan il - prodott.
4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ 'amministrazzjoni
Intramuscular use
Skeda għat- tilqim
Vaccination schedule:
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 wa] da 4 [img] at wara.
Primary vaccination course
B ’ din it - tilqima l- immunita kontra l - influwenza taż- żwiemel isservi ta ’ l- inqas 12 il- xahar.
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
(ara skema).
Revaccination
3/ 16 T1 T2 0 1 skema 1
This revaccination results in immunity to equine influenza lasting at least 12 months.
T3 6
3/ 16 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 ’ te] id ta ’ kolostrum, tilqima addizjonali tista ’ ting] ata fir- raba xahar segwita bil - programm komplut ta ’ va`` inazzjoni (l- ewwel kors ta ’ tiqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
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 ġie osservat apparti ftit sintomi ta ’ dipressjoni fil- jum tal - vaċċinazzjoni.
4.11 Withdrawal period(s)
4. 11 Perjodu ta ’ Tiżmim
To stimulate active immunity against Equine influenza ATC-vet code:
Biex tistimula immunita attiva kontra l- influwenza taż- żwiemel.
Purified Saponin, Cholesterol, Phosphatidylcholine, Thiomersal traces
6. 1 Lista ta ’ ingredjenti Saponin purifikat, kolesterol, Fosfatidilkolin, traċċi ta ’ tajomersal.
6.4 Special precautions for storage
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
Store at 2-8°C, protected from light.
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
4/ 16 Package size:
Daqs tal- pakketti:
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
4/ 16 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
5/ 16 ANNEX II
5/ 16 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
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
7/ 16 ANNEX III
7/ 16 ANNESS III
9/ 16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
A/ equine-1/ Prague 56 (100 AU), A/ equine-2/ Newmarket/ 1/ 93 (50 AU), A/ equine 2/ Newmarket/ 2/ 93 (50 AU).
A/ equine- 1Prague 56 (100AU), A/ equine- 2/ Newmarket/ 1/ 93 (50 AU), A/ equine 2/ Newmarket/ 2/ 93 (50AU)
1, 5 or 10 x 1 dose
1, 5 jew 10 x 1 doża
Active immunisation of horses against equine influenza.
Immunita attiva għaż- żwiemel kontra l- influwenza taż- żwiemel.
METHODS AND ROUTE OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
{month/ year}
Jiskadi {xahar / sena}
For animal treatment only Veterinary medicinal product subject to prescription.
Għal Trattament ta ’ l- Annimali Biss Għandu jingħata biss b’ riċetta veterinarja.
Keep out of reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
11/ 16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
13/ 16 PACKAGE LEAFLET FOR:
13/ 16 FULJETT TA ’’ TAGĦRIF FIL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Active substance Purified haemagglutinin subunits from equine influenza viruses:
Sub- partijiet 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
100 AU2 A/ equine- 1 / Prague/ 1/ 56 A/ equine- 2 / Newmarket/ 1/ 93 A/ equine- 2 / Newmarket/ 2/ 93 2:
Excipient Thiomersal traces
Traċċi ta ’ Tajomersal
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Immunizzazzjoni attiva ġħal żwiemel ta ’ aktar minn sitt xhur, kontra l- influwenza taż- żwiemel, biex tnaqqas is- sintomi kliniċi u l - eskrezzjoni tal- virus, wara l- infezzjoni.
Influenza Onset of immunity:
Influwenza Bidu ta ’ immunita:
2 weeks after the primaryvaccination course 5 months after the primaryvaccination course 12 months after the first revaccination
2 [img] at wara l- ewwel kors ta ’ tilqim 5 xhur wara l- ewwel kors ta ’ tilqim 12 - il xahar wara l- ewwel revaċċinazzjoni
5.
14/ 16 5.
2 Antigenic units
EFFETTI MHUX MIXTIEQA
ADVERSE REACTIONS
Nef] iet mifruxa (iebsin jew rotob, diametru mass.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
5 cm) jistg] u jfe [[u 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, for 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 eċċezzjonali ġieli jdum sa tlett ijiem.
1 ml.
1 ml intramuskolari.
Vaccination schedule:
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 wa] da 4 [img] at wara.
Primary vaccination course
B din it - tilqima l- immunita kontra l - influwenza taż- żwiemel iddum minn ta ’ l- inqas 12 il- xahar.
Revaccination
T1 T2 0 1 skema 1
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 4 xahar segwita bil programm komplut ta ’ vaċċinazzjoni (l- ewwel kors ta ’ tiqim ta ’ 6 xhur u doża oħra 4 ġimgħat wara).
Administer 1 ml of vaccine i. m..
Ħalli t- temperatura tal- vaċċin tilħaq bejn 15°C - 25°C Agħti 1 ml tal - vaċċin fil- muskolu.
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 tilqima oħra.
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 use after the expiry date stated on the label.
Tużax wara d- data ta ’ l- iskadenza li hemm fuq it- tikketta.
Cardboard box with 10 glass vials of 1 ml.
Kaxxa tal - kartun b 10 vjali 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.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni magħmula mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- 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 ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid iktar informazzjoni fuq il- bażi tar- rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll ta ’ l- EPAR).
What is Equilis StrepE?
X’ inhu Equilis StrepE?
Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria.
Equilis StrepE huwa vaċċin li fih is- sustanza attiva live deletion mutant Streptococcus equi bacteria.
No adjuvant or preservative is included.
Ebda addittiv jew preservattiv m’ huwa inkluż.
Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection.
Equilis StrepE huwa disponibbli bħala lyophilisate (pelit imnixxfa bil- friża) li hija magħmula f’ sospensjoni għal injezzjoni.
The vaccine is provided together with the solvent, applicator and a syringe with needle.
Il- vaċċin huwa pprovdut flimkien mas- solvent, applikatur u siringa b’ labra.
This is the first vaccine to be licensed for horses in the EU against strangles.
Dan huwa l- ewwel vaċċin li nħarġitlu liċenzja biex jintuża fuq iż- żwiemel fl- UE kontra strangles.
What is Equilis StrepE used for?
Għalxiex jintuża Equilis StrepE?
Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi.
Equilis StrepE jintuża biex ilaqqam liż- żwiemel kontra mard respiratorju ikkawżat mill- batterji Streptococcus equi.
The highly contagious and common disease caused by this bacterium is commonly called ‘ strangles’.
Il- marda kontaġġjuża u komuni ferm ikkawżata minn dan il- batterju hija magħrufa b’ mod komuni bħala ‘ strangles ’.
In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing.
Fi strangles, il- glandoli limfatiċi fir- ras jistgħu jsiru kbar biżżejjed biex jimblokkaw il- passaġġ ta ’ l- arja, u b’ hekk iż- żiemel ikollu diffikultà biex jieħu nifs.
This is a highly contagious disease and a common bacterial infection in horses.
Din hija marda kontaġġjuża ferm u hija infezzjoni batterjali komuni fiż- żwiemel.
Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).
Equilis StrepE inaqqas is- sinjali kliniċi tal- marda u l- okkorrenza ta ’ axxesi tal- glandoli limfatiċi (ġbir ta ’ materja).
How does Equilis StrepE work?
Kif jaħdem Equilis StrepE?
Equilis StrepE is a vaccine.
Equilis StrepE huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema ta ’ l- immunità (id - difiża naturali tal- ġisem) kif tiddefendi ruħha kontra l- mard.
Equilis StrepE contains small amounts of a type of bacterium called S. equi.
Equilis StrepE fih ammonti żgħar ta ’ tip ta ’ batterju imsejjaħ S. equi.
When a horse is given the vaccine, the immune system recognises the bacteria as ‘ foreign’ and makes antibodies against them.
Meta żiemel jingħata l- vaċċin, is- sistema ta ’ l- immunità tagħraf il- batterji bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria.
Fil- futur, is- sistema ta ’ l - immunità tkun tista ’ tipproduċi antikorpi aktar malajr meta tkun esposta mill- ġdid għall- batterji.
The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse’ s body and is less likely to cause disease.
Ir- razza tal- batterju inkluża f’ Equilis StrepE kellha xi ġeni mneħħija, sabiex tikber inqas tajjeb ġewwa l- ġisem taż- żiemel u b’ hekk hija inqas probabbli li tikkawża marda.
This makes it suitable for use in a vaccine.
Dan jagħmilha adegwata sabiex tintuża f’ vaċċin.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Equilis StrepE?
Horses from four months of age should receive a second injection after four weeks.
Il- vaċċin jingħata bħala injezzjoni ta ’ 0. 2- ml fuq ġewwa tax- xoffa ta ’ fuq.
All horses should be revaccinated every three months to maintain immunity.
Iż- żwiemel li għandhom erba ’ xhur jew aktar għandhom jirċievu tieni injezzjoni wara erba ’ ġimgħat.
Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present.
Equilis StrepE għandu jintuża biss fuq żwiemel b’ saħħithom li qegħdin f’ riskju li jieħdu infezzjoni b’ S. equi minħabba kuntatt ma ’ żwiemel minn żoni fejn il- batterju huwa magħruf li huwa preżenti.
What benefit has Equilis StrepE shown during the studies?
X’ benefiċċju wera Equilis StrepE matul l- istudji?
The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
L- istudji wrew li Equilis StrepE huwa effettiv fl- immunizzazzjoni attiva taż- żwiemel li għandhom 4 xhur jew aktar kontra Streptococcus equi sabiex jitnaqqsu s- sinjali kliniċi u l - okkorrenza ta ’ axxesi tal- glandoli limfatiċi.
Fewer of the horses receiving Equilis StrepE had symptoms of strangles.
Inqas żwiemel li kienu qed jieħdu Equilis StrepE kellhom simtomi ta ’ strangles.
They also had fewer abscesses and fewer lymph nodes affected.
Kellhom ukoll inqas axxesi u inqas glandoli limfatiċi affettwati.
What is the risk associated with Equilis StrepE?
X’ inhu r- riskju assoċjat ma ’ Equilis StrepE?
Only healthy horses which are at risk of infection should be vaccinated.
Żwiemel b’ saħħithom biss li qegħdin f’ riskju li jieħdu infezzjoni għandhom jiġu mlaqqmin.
After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful.
Wara injezzjoni, tiżviluppa nefħa fis- sit ta ’ l- injezzjoni fi żmien erba ’ sigħat u s- sit ta ’ l - injezzjoni jista ’ jsir sħun jew jiżviluppa uġigħ.
The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm.
Ir- reazzjoni hija l- akbar wara jumejn jew tlieta wara l- injezzjoni, madankollu, iż- żona affettwata ma għandhiex tkun akbar minn 3 bi 8 ċm.
The swelling should disappear within three weeks and should have no effect on the horse’ s appetite, nor cause it any discomfort.
In - nefħa għandha tisparixxi fi żmien tliet ġimgħat u ma għandux ikollha effett fuq l- aptit taż - żiemel, lanqas m’ għandha tikkawżalu xi skumdità.
In very rare cases an abscess and discharge may develop at the injection site, and the lymph nodes in the head may enlarge, which may be painful for a short while.
F’ każijiet rari ferm, tista ’ tiżviluppa axxesi u xi nixxija fis- sit ta ’ l- injezzjoni, u l- glandoli limfatiċi fir- ras jistgħu jikbru, tant li jistgħu jipproduċu xi uġigħ għal ftit żmien.
An increase in body temperature of up to 2°C may occur on the day of vaccination.
Fil- jum tat- tilqima tista ’ sseħħ żieda fit- temperatura tal - ġisem ta ’ mhux aktar minn 2°C.
In rare cases, loss of appetite, fever and shivering may be observed.
F’ każijiet rari jista ’ jiġi osservat nuqqas ta ’ aptit, deni u tregħid.
In very rare cases depression may develop.
F’ każijiet rari tista ’ tiżviluppa dipressjoni.
In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected.
Fil- każ ta ’ injezzjoni personali aċċidentali, li tista ’ tikkawża infjammazzjoni b’ uġigħ sever u nefħa, fittex parir mediku minnufih u uri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib, anki jekk ikun ġie injettat ammont żgħir.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm għandu jgħaddi żmien qabel l- annimal ikun jista ’ jinqatel u l- laħam użat għall- konsum mill- bniedem (perjodu ta ’ ristrezzjoni)?
The withdrawal period is zero days.
Il- perjodu ta ’ ristrezzjoni huwa ta ’ żero jiem.
Why has Equilis StrepE been approved?
Għaliex ġie approvat Equilis StrepE?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Equilis StrepE jisbqu r- riskji għall- immunizzazzjoni taż- żwiemel kontra S. equi biex jitnaqqsu s- sinjali kliniċi u l- okkorrenza ta ’ axxesi tal- glandoli limfatiċi, u rrakkomanda li Equilis StrepE jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju- riskju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Equilis StrepE:
Tagħrif ieħor dwar Equilis StrepE:
The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B. V. on 7 May 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Equilis StrepE lil Intervet International B. V. fis- 7 ta ’ Mejju 2004.
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/ pakkett ta ’ barra.
This summary was last updated in September 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Settembru 2007.
Page 2/ 2
Paġna 3/ 3
Invented name
Isem Kummerċjali
Route of administration
Speċi għal Mod ta ’ xiex huwa Amministrazzjoni ndikat il - prodott
Withdrawal period
Żmien ta ’ Tiżmim
109.0 to 109.4 cfu of live
109. 0 sa 109. 4 cfu ta ’ bakterja ħajja modifikata tat - tip Streptococcus equi strejn TW928
Lyophilisate and solvent for suspension for
Lifolizzat u solvent għas - suspensjoni għal injezzjoni
Submucosal injection
Injezzjoni fis - submukosa
1 dose Solvent:
Solvent:
0.5 ml
0. 5 ml fjala (ħġieġ)
10 vials powder Zero days 10 vials solvent
10 fjali ta ’ trab 10 fjali ta ’ solvent 10 applikaturi 10 siringi bil - labar
injection
Xejn
Equilis StrepE, lyophilisate for suspension for injection, for horses
Equilis StrepE, lajofiliżejt, għal suspensjoni għal injezzjoni, għaż- żwiemel
Per dose of 0.2 ml vaccine:
Kull doża ta ’ 0. 2ml ta ’ vaċċin:
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu1
Deletion mutant ħaj ta ’ Streptococcus equi strejn TW928 109. 0 to 109. 4 CFU1 CFU1: partijiet li jiffurmaw kolonja
For a full list of excipients, see section 6.1.
Għall- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Lyophilisate for suspension for injection
Lajofiliżejt, għal suspensjoni g] al injezzjoni
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Immunizzazzjoni għaż- żwiemel kontra Streptococcus equi biex tnaqqas is- sinjali kliniċi u li joħorġu nefħiet bil- materja fl- ogħqod tal- limf.
Onset of immunity:
Bidu ta ’ l- immunita:
The onset of immunity is established as 2 weeks after basic vaccination.
2 ġimgħat wara l- kors bażiku ta ’ tilqim
The duration of immunity is up to 3 months.
L- immunita ddum sa 3 xhur
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e. g. stables with horses that travel to shows and/ or competitions in such areas, or stables that obtain or have livery horses from such areas.
Stalel bi żwiemel li jivjaġġaw għal wirjiet u / jew kompetizzjonijiet f’ wesgħat bħal dawn, jew stalel li jakkwistaw jew ikollhom żwiemel minn postijiet bħal dawn.
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
It- tifrix tal- istrejn tal- vaċċin mill- post tal- injezzjoni, jibqa ’ jkun osservat sa erbat ’ ijiem wara t- tilqima.
2/ 23 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 2/ 24 mill- istudji tal- ħarsien tas- saħħa li saru waqt li kienet qed tiġi żviluppata Equilis StrepE.
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Minħabba li l- inċidenza ta ’ purpura haemorrhagica hija baxxa ħafna, wieħed ma jistax jinjora għal kollox, il- fatt li tista ’ sseħħ.
Only healthy horses should be vaccinated.
Annimali b’ saħħithom biss għandhom jiġu mlaqqma.
Ensure that the lyophilisate is completely reconstituted before use.
Kun żgur li l- lajofiliżejt huwa mħawwad tajjeb qabel tuża.
Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Tilqima bażika li ssir waqt li l- marda qed tinfirex mhix effikaċi, minħabba li l- immunita mhix suffiċjenti sakemm it- tilqima bażika saret kollha.
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Għandha tingħata attenzjoni speċjali meta jitwaħħal l- applikatur mal- labbra sabiex jiġu evitat ġrieħi minn tingiż bil- labbra.
In case of accidental self injection, seek medical advice immediately and show the package insert or the label to the physician.
F' każ ta 'amministrazzjoni lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta' informazzjoni li jkun fih ġewwa.
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Dan il- prodott fih deletion mutant b’ kapaċita limitata ta ’ tkabbir f’ tessut mammiferu.
Accidental self injection may result in an inflammatory reaction with severe pain and swelling.
Injezzjoni bi żball lilek innifsek tista 'tirriżulta f' reazzjoni flammatorja b’ uġigħ kbir u nefħa.
If you are accidentally injected with this product seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Jekk tiġi njettat bi żball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'informazzjoni li tinsab fil- pakkett miegħek.
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Dan il- prodott fih strejn tal- vaċċin Streptococcus equi, li hu oksotrofik dilixin mutant ħaj li l - kapaċitajiet li jagħmel il- ħsara ġew imwaqqfa.
However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection.
Madankollu it- taħlit btteriku ta ’ dan il- prodott jista ’ jikkawza reazzjoni flammatorja b’ nefħiet qawwija u li juġgħu f’ każ ta ’ injezzjoni aċcidentali.
Antiinflammatory therapy is indicated even if only a very small amount of the product in injected.
Kura antinlammatorja hija ndikata, anke jekk ġie njettat ammont żgħir ħafna ta ’ prodott.
An additional antibiotic treatment should be considered for safety reasons.
Trattament addizzjonali t’ antibijotiċi għandu jkun ikkunsidrat, għal raġunijiet ta ’ sigurta.
The sensitivity of the vaccine strain to antibiotics is listed below (SPC under section 4.8)
Is- sensitivita tal- istrejn tal- vaċċin għal antibijotiċi hu mniżżel aktar l- isfel (SPC; Sezz 4. 8)
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Wara t- tilqima, reazzjoni li tinħass bħala nef] a mifruxa li tista ’ tkun s] una u tu[ a ’, ti\ viluppa fil- post ta ’ l- injezzjoni f’ ħin ta ’ erba ’ siegħat.
This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort.
Ir- reazzjoni tinħass l- aktar 2 - 3 ijiem wara t- tilqima, fuq wesa ta ’ 3 bi 8ċm Din in- nefħa titlaq kompletament fi żmien tlett ġimgħat u normalment ma għandha l- ebda effett fuq l- aptit u ma jidhirx li ddejjaq lill - annimal imlaqqam.
The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge fluid and inflammatory cells.
L- organiżmu fit- tilqima jista ’ jistabilixxi fjammazzjoni żgħira li tnixxi, lokalment fejn ingħatat it- tilqima, li tikkawża ksur tal - mukoża tax- xoffa u tnixxija ta ’ fluwidu u ċelloli fjammatorji.
A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Huwa komuni li tnixxija ħafifa mċajpra toħroġ mill- post tal- injezzjoni fil- mukoża wara 3 jew 4 ġranet wara t- tilqima.
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Jista ’ jkun hemm tkabbir, li juġa iżda jmur, tal- għoqiedi tal- limf tar- retrofarinġja u tal- parti t’ isfel tal - ħalq fil- ftit ġranet ta ’ wara t- tilqima.
In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
F’ każi rari ħafna tista ’ tifforma selħa bil- materja fil- post tal - injezzjoni jew fl- għoqiedi tal- limf tal- post.
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination.
Barra minn hekk, fil- ġurnata tat- tilqima jista ’ jkun hemm żieda fit- temperatura tal- warrani sa 2oC.
In rare cases, inappetance, fever and shivering may be observed.
F’ każijiet rari ħafna jista ’ jiġi osservat nuqqas t’ aptit, deni u tertir.
In very rare cases depression may develop.
F’ każi rari ħafna tista ’ tiżviluppa dipressjoni.
3/ 23 4.7 Use during pregnancy, lactation or lay
3/ 24 4. 7 Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
Do not use in pregnant or lactating mares.
Tużax fid- dwieb waqt it- Tqala jew fi żmien il- ħalib.
Limited information is available on the safety and efficacy from the use of this vaccine with any other.
Hemm informazzjoni limitata ħafna dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor.
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.
Do not use antibiotics within one week after vaccination.
Tużax antibijotiċi fi żmien ġimgħa wara t- tilqima.
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimetroprim-sulfa combinations.
L- istrejn tal- vaċċin huwa reżistenti għal aminoglikosidi, sulfonamidi, flumekwin u kombinazzjonijiet ta ’ trimetoprim- sulfa.
The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
L- istrejn tal- vaċċin huwa sensittiv għal peniċillin, tetraċiklini, makrolidi u linkomiċin.
Submucosal vaccination with 0.2 ml of reconstituted product.
Tilqima fis- submukoża b’ 0. 2ml tal- prodott imħallat.
Allow the solvent to reach room temperature (15 - 25°C).
Ħalli s- solvent jilħaq it- temperatura tal- kamra (15 – 25oC).
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
B’ mod asettiku, żid il- lajofilizejt ma 0. 3ml tas- solvent sterili pprovdut.
Do NOT shake and wait 1 minute after addition of the solvent.
Tħawwadx u ħalli minuta wara li żżid is- solvent.
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
Iġbed 0. 2ml mit- tilqim imħallat, ġos- siringa pprovduta (ara immaġni 1 u qabad l- applikatur mal- labra (ara immaġni 2).
Restrain the animal’ s head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip.
Żomm ras l- annimal, erfa x- xoffa ta ’ fuq u daħħal il- labra fin- naħa ta ’ ġewwa tax- xoffa, sakemm l- applikatur jistrieħ fuq ix- xoffa.
Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
Agħti l- kontenut kollu tas- siringa ġewwa x- xoffa ta ’ fuq, (ara immaġni 3).
Figure 1
Figura 1.
Figure 2
Figura 2.
Figure 3
4/ 24 Figura 3.
4/ 23 Vaccination scheme:
L- ewwel kors ta ’ tilqim
Basic vaccination: horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Tilqima bażika: żwiemel minn erba ’ xhur ‘ il fuq għandhom jirċievu żewġ tilqimiet ta ’ doża waħda kull darba, b’ intervall ta ’ erba ’ ġimgħat bejn waħda w’ oħra.
Revaccination:
Rivaċċinazzjoni
Revaccinate every three months to maintain immunity.
Erġa ’ laqqam kull tlett xhur biex iżżomm l- immunita.
A priming response is maintained for up to six months after basic vaccination.
Ir- rispons primarju lejn it- tilqima bażika jinżamm sa sitt xhur wara t- tilqima.
Therefore only a single dose of vaccine is needed to restore immunity.
Għaldaqstant ikun hemm bżonn ta ’ doża wa] da biss terġa tqajjem l- immunita.
It is recommended that all horses stabled together are vaccinated.
Huwa rakkomandat li ż- żwiemel kollha li jinżammu flimkien fl- istalel jiġu mlaqqma.
In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Minbarra s- sinjali kliniċi mniżżla taħt sezzjoni 4. 6, tilqima b’ għaxar darbiet id- doża rakkomandata tista ’ tikkawża bħal selħa f’ waħda mill- għoqod tal- limf submandibulari.
The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Dawn is- selħiet jistgħu inixxu materjal purulenti minn ġimgħatejn wara t- tilqima, iżda imbagħad jgħaddu mingħajr il- bżonn ta ’ ntervent fi żmien xahar.
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Barra minn hekk, jista ’ jkun hemm żieda sa 2. 5oC fit- temperatura tal- warrani, dak in- nhar tat- tilqima.
QI05AE live bacterial vaccine
Kodici ATĊ veterinarja QI05AE: tilqima b’ batterja ħajja.
To stimulate immunity against Streptococcus equi.
Sabiex tistimula l- immunita kontra Streptococcus equi.
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
L- istrejn tal- vaċċin huwa deletion mutant b’ potenzjal baxx li jista ’ jikber f’ tessut mammiferu.
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 disseminate 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.
NAO-1 stabiliser Water for injections
5/ 24 Ilma għal injezzjoni.
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Tħallatx ma prodotti mediċinali veterinarji oħra, ħlief mas- solvent provdut għall- użu mat- tilqima.
Lyophilisate and solvent:
Lajofiliżejt u solvent:
5/ 23 Reconstituted vaccine should be used within 4 hours.
3 snin Il- vaċċin imħallat għandu jintuża fi żmien 4 siegħat.
Store refrigerated (2°C – 8°C).
Aħżen fil- friġġ (2°C – 8°C).
Solvent:
Ipproteġi mid- dawl Solvent:
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
Each package of Equilis StrepE contains:
Kull pakkett ta ’ Equilis StrepE:
10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
10 fjali bil- lajofiliżejt u 10 fjali b’ 0. 5ml ta ’ solvent, kull wieħed minn dawn huwa fjala tal- ħġieġ, Tip I ta ’ 3ml, magħluqa b’ tapp tal- gomma u ssiġillat b’ kappa tal - aluminjum b’ kodiċi fuqha, 10 applikaturi 10 siringi bil- labra.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi l- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant approvat mill- Awtorità Kompetenti tal- pajjiż.
Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35, NL – 5831 AN Boxmeer Olanda
EU/ 2/ 04/ 043/ 001
EU/ 204/ 043/ 001
7 May 2004
07/ 05/ 2004
Not applicable
Mhux Applikabbli.
6/ 23 ANNEX II
6/ 24 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
7/ 23 A.
7/ 24 A.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER REGARDING SUPPLY OR 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 jiġu mogħtija biss b’ riċetta veterinarja.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
Substance
Sustanza
MRL status
Stat tal- LMR
Streptococcus equi strain
Strejn ta ’ Streptococcus equi Ilma għal injezzjoni
Not within the scope of Council Regulation (EC) 2377/ 90
Ma jaqax taħt ir - regolament tal- Kunsill (EC) 2377/ 90 Ma jaqax taħt ir - regolament tal- Kunsill (EC) 2377/ 90
Active principles of biological origin intended to produce active or passive immunity are not within the scope of the Regulation
Prinċipji attivi ta ’ oriġini bijoloġika, intenzjonati sabiex jipproduċu immunita attiva jew passiva, ma jaqghux taħt dan ir- Regolament.
8/ 23 ANNEX III
8/ 24 ANNESS III
10/ 23 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Equilis StrepE, lyophilisate for suspension for injection, for horses
Equilis StrepE, lajofiliżejt, għal suspensjoni g] al injezzjoni, għaż- żwiemel
STATEMENT OF ACTIVE AND OTHER SUBSTANCE
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Deletion Mutant ħaj ta ’ Streptococcus equi strejn TW928 109. 0 to 109. 4 CFU1
Lyophilisate for suspension for injection
Lajofiliżejt, għal suspensjoni għal injezzjoni
10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
10 x 1 doża tal- vaċċin 10 x 1 doża tas- solvent 10 applikaturi 10 siringi bil- labra
Horses.
Żwiemel
After reconstitution administer 0.2 ml submucosally to the inside of the upper lip.
Wara li tħallat, agħti 0. 2ml fis- submukoża, n- naħa ta ’ ġewwa tax- xoffa ta ’ fuq.
Read the package insert before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
9.
11/ 24 9.
EXP solvent {month/ year} EXP vaccine {month/ year}
Solvent Jiskadi {xahar / sena} Vaċċin Jiskadi {xahar / sena}
Store refrigerated (2°C – 8°C).
Aħżen fil- friġġ (2oC – 8oC).
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ ghandux bżonn kundizzjonijiet speċjali ta ’ ħażna.
Reconstituted vials should be used within 4 hours.
Fjali mħallta għandhom jintużaw f’ ħin ta ’ erba ’ siegħat.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
THE WORDS "FOR ANIMAL TREATMENT ONLY"
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
Wim de Körverstraat 35 NL - 5831 AN Boxmeer
Wim de Körverstraat 35, NL – 5831 AN Boxmeer Olanda
< batch > {number}
Lott {numru}
12/ 23 PARTICULARS TO APPEAR ON THE INNER BOX WITH VACCINE
12/ 24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Deletion Mutant ħaj ta ’ Streptococcus equi strejn TW928 109. 0 to 109. 4 CFU
10 x 1 dose
10 x 1 doża
INDICATION
INDIKAZZJONI( JIET)
For immunisation against Streptococcus equi
Immunizzazzjoni għaż- żwiemel kontra Streptococcus equi.
For submucosal injection after reconstitution
Għall- titqib fis- submukoża wara li tħallat.
10.
13/ 24 10.
Exp {month/ year}
Jiskadi {xahar / sena}
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
14/ 23 PARTICULARS TO APPEAR ON THE INNER BOX WITH SOLVENT
14/ 24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA’ ĠEWWA.
Equilis StrepE - solvent
Equilis StrepE - solvent
See package leaflet.
Ara l- fuljett informattiv
Zero days.
0 ġranet
THE WORDS "FOR ANIMAL TREATMENT ONLY"
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ”
12.
17.
< lot > {number}
Lott {numru}
16/ 23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16/ 24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKJAR IMMEDJAT
Label of the vaccine (small vial)
Tikketta tal- vaċċin (fjal iż- żgħir)
QUANTITY OF THE ACTIVE SUBSTANCE
KWANTITA TAS- SUSTANZA ATTIVA
Live Streptococcus equi.
Streptococcus equi ħaj
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM, JEW NUMRU TA ’ DOŻI
For submucosal use.
Għal użu fis- submukoża
< Batch > {number}
Lott {numru}
17/ 23 Label of the solvent (small vial)
17/ 24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKJAR IMMEDJAT
Equilis StrepE - solvent
Solvent tal- Equilis StrepE
See package insert.
Aqra l- fuljett informattiv
Exp {month/ year}
Jiskadi {xahar/ sena}
18/ 23 B.
18/ 24 B.
19/ 23 PACKAGE LEAFLET
19/ 24 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu1
Deletion mutant ħaj ta ’ Streptococcus equi strejn TW928 109. 0 to 109. 4 CFU1
The onset of immunity is established as two weeks after vaccination.
{ie stabbilit li l- immunita tibda wara ġimgħatejn li tingħata t- tilqima.
The duration of immunity is up to 3 months.
L- immunita ddum sa tlett xhur.
Do not use in pregnant or lactating mares.
Tużax fi dwieb waqt it- tqala jew fi żmien il- ħalib.
6 ADVERSE REACTIONS
EFFETTI MHUX MIXTIEQA
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Wara t- tilqima, reazzjoni li tinħass bħala nefħa mifruxa li tista ’ tkun sħuna u tuża ’, tiżviluppa fil- post ta ’ l- injezzjoni f’ ħin ta ’ erba ’ siegħat.
20/ 23 Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
20/ 24 Jista ’ jkun hemm tkabbir, li juġa iżda jmur, tal- għoqiedi tal- limf tar- retrofarinġja u tal- parti t’ isfel tal - ħalq fil- ftit ġranet ta ’ wara t- tilqima.
7 TARGET SPECIES
SPEĊI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
Submucosal vaccination of 0.2 ml of reconstituted product.
Tilqima fis- submukoża b’ 0. 2ml tal- prodott imħallat.
Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Tilqima bażika: żwiemel minn erba ’ xhur ‘ il fuq għandhom jirċievu żewġ tilqimiet ta ’ doża waħda kull darba, b’ intervall ta ’ erba ’ ġimgħat bejn waħda w’ oħra.
Revaccination:
Rivaċċinazzjoni:
Therefore only a single dose of vaccine is needed to restore immunity.
Għaldaqstant ikun hemm bżonn ta ’ doża waħda biss terġa tqajjem l- immunita.
9 ADVICE ON CORRECT ADMINISTRATION
PARIR SABIEX TAMMINISTRA B' MOD KORRETT
Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
B’ mod asettiku, żid il- lajofilizejt ma 0. 3ml tas- solvent sterili pprovdut.
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine (see Figure 1) and connect the applicator to the needle (see Figure 2).
Iġbed 0. 2ml mit- tilqim imħallat, ġos- siringa pprovduta (ara immaġni 1 u qabad l- applikatur mal- labra (ara immaġni 2).
21/ 23 Figure 2
21/ 24 Figura 2.
Figure 3
Figura 3.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ kondizzjonijiet ta ’ ħażna speċjali.
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Tħallatx ma ebda prodott mediċinali veterinarju ieħor, ħlief mas- solvent provdut għall- użu ma dan il - vaċċin.
The vaccine strain is sensitive to penicillins, tetracyclins, macrolides and lincomycin.
L- istrejn tal- vaċċin huwa sensittiv għal peniċillin, tetraċiklini, makrolidi u linkomiċin.
Only healthy horses should be vaccinated.
Żwiemel b’ saħħithom biss għandhom jiġu mlaqqma.
Ensure that the lyophilisate is completely reconstituted before use.
Kun ċert li l- lajofiliżejt tħawwad kollu qabel tuża.
22/ 23 Special precautions to be taken by the person administering the veterinary medicinal product to animals
22/ 24 Prekawzjonijiet specjali li l- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali għandha tieħu
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Attenzjoni speċjali għandha tingħata meta jitwaħħal l- applikatur mal- labbra sabiex jiġu evitati ġrieħi minn tingiż bil- labbra.
In case of accidental self injection, seek medical advice immediately and show the package insert or the label to the physician
F' każ ta 'amministrazzjoni lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta' informazzjoni li jkun fih ġewwa.
The sensitivity of the vaccine strain to antibiotics is listed above.
Is- sensitivita tal- istrejn tal- vaċċin għal antibijotiċi hu mniżżel aktar l- isfel.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL - PAKKETT