qanastek/EMEA-V3 huggingface dataset:
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242) ≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID*50 *Fluorescent assay infectious dose 50% Clostridium tetani toxoid
Influenza A/ equi- 2 / Ohio/ 03 {H3N8} virus rikombinat tal- Canarypox (vCP2242) > 5. 3 log 10 FAID * 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} virus rikombinat tal- Canarypox (vCP1533) > 5. 3 log 10 FAID* 50 doża infettiva florexxenti ta ’ prova 50% Clostridium tetani toxoid............................................................................................ > 30 IU ** ** titolu ta ’ antikorp antitossiku indott wara tilqim ripetut fis- sera tal- fenek ta ’ l- Indi skond il Ph. Eur.
** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph.
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Carbomer
GĦAMLA FARMAĊEWTIKA
4 mg
4 TAGĦRIF KLINIKU
Suspension for injection.
4. 1 Speċi li fuqhom ser jintuża l- prodott
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Immunizzazzjoni attiva ta ’ żwiemel ta ’ 4 xhur jew akbar kontra l- influwenza fiż- żwiemel sabiex tnaqqas sinjali kliniċi u tneħħija tal- virus wara infezzjoni u kontra t- tetnu biex tipprevjeni l- mortalità.
14 days after primary vaccination course.
14 il- ġurnata wara l- ewwel kors ta ’ tilqim.
Duration of immunity induced by the vaccination scheme:
Tul ta ’ l- immunità indotta mill- iskema tat- tilqim:
5 months after primary vaccination course and 1 year after the third vaccination.
5 xhur wara l- ewwel kors ta ’ tilqim u sena wara t - tielet tilqima.
4.4 Special warnings
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott >
4.5 Special precautions for use
2/ 17 4. 5 Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals Only healthy animals should be vaccinated.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
2/ 17 Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' kas li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
1.5 °C) may occur for 1 day, exceptionally 2 days. • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
• Jista ’ jkun hemm nefħa transitorja fil- post tal- injezzjoni (dijametru massimu ta ’ 5cm) li tinżel fi żmien erbat ijiem. • F’ każi rari jista ’ jkun hemm uġigħ u ipertermja lokali. • Għal ġurnata waħda u rarament għal tnejn, jista jkun hemm ħarira deni (massimu 1. 5˚C). • F’ ċirkostanzi eċċezzjonali, apatija u nuqqas ta ’ l- aptit jistgħu jiġu osservati l- għada tal - vaċċinazzjoni. • F’ ċirkostanzi eċċezzjonali, jista ’ jkun hemm reazzjoni ta ’ ipersensittività li tista ’ tirrikjedi kura sintomatika xierqa.
No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL’ s inactivated vaccine against rabies.
L- ebda effett ma ġie osservat meta ġie amministrat il- vaċċin, simultanjament, iżda f’ post separat, mal - vaċċin inattivat tal- MERIAL kontra ir- rabbja.
For intramuscular use.
Għall- użu fil- muskolu.
For the administration of the vaccine, use sterile and antiseptic-free and/ or disinfectant-free material.
Għall- amministrazzjoni tal- vaċċin, uża materjal sterilizzat li m’ għandux diżinfettant jew antisettiku.
Shake the vaccine gently before use.
Ixxejkja ftit il- vaċċin qabel l- użu.
Administer one dose (1ml), by intramuscular injection, preferably in the neck region, according to the following schedule: • Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later • Revaccination:
Amministra doża waħda (1ml) b’ injezzjoni fil- muskolu, preferibbilment fl- għonq, skond din l- iskeda li ġejja: • L- ewwel kors ta ’ tilqim: l- ewwel injezzjoni minn 5 – 6 xhur, it- tieni injezzjoni 4 – 6 ġimgħat wara. • It- tieni kors:
5 months after primary vaccination course followed by annual booster injections 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 5-6 months of age and 4-6 weeks later followed by revaccination).
F’ kas li jiżdied ir- riskju ta ’ infezzjoni jew jekk ma jkunx hemm kolostrum suffiċjenti, injezzjoni oħra tista ’ tingħata ta ’ 4 xhur segwita mill- programm komplet ta ’ tilqim (l- ewwel kors ta ’ tilqim ta ’ 5 – 6 xhur u 4 – 6 ġimgħat wara segwit mit- tieni kors).
Following the administration of overdoses of vaccine, no side-effects other than those described under 4.6 have been observed.
Wara li ġiet amministrata doża eċċessiva tal- vaċċin, l- ebda effetti, ħlief dawk deskritti taħt 4. 6, ma ġew osservati.
4.11 Withdrawal period(s)
3/ 17 4. 11 Perjodu ta 'Tiżmim
QI05AI01
Q105A101
The vaccine stimulates active immunity against equine influenza and tetanus.
Il- vaċċin jistimola immunità kontra l- influwenza u t- tetnu fiż- żwiemel.
3/ 17 The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
L- istrejns vCP2242 u vCP1533 tal- vaċċin huma virusijiet rikombinati tal- canarypox li jesprimu il - ġene hæmagglutinin HA mill- istrejns tal- virus tal- influwenza fiż- żwiemel A/ equi- 2 / Ohio/ 03 (strejn amerikan) u A/ equi- 2/ Newmarket/ 2/ 93 (strejn ewropew), rispettivament.
After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Wara l- innokulazzjoni, il - virusijiet ma jimmoltiplikawx fiż- żiemel iżda jesprimu il- proteini protettivi.
As a consequence, these components induce immunity against equine influenza virus (H3N8).
Konsegwentement, dawn il- komponenti jinduċu immunità kontra l- virus tal- influwenza fiż- żwiemel (H3N8).
Do not mix with any veterinary medicinal product.
Tħallatx ma prodott mediċinali veterinarju ieħor.
18 months.
18 il- xahar.
Use immediately after opening.
Uża immedjatament la darba miftuħ.
Type I glass vial Butyl elastomer closure and aluminium cap
Fjala tal- ħġieġ ta ’ l- Ewwel Tip Tapp tal- lastku u tapp tal- aluminju.
Box of 10 vials of 1 dose.
Kaxxa ta ’ 10 fjali ta ’ doża.
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 diżinfettant approvat mill- Awtorità Kompetenti tal- pajjiż.
4/ 17 10 DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
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
Influenza component:
Il- komponent tal- Influwenza:
Merial, Laboratoire Porte des Alpes Rue de l'Aviation, F-69800 Saint Priest, France
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 Saint- Priest France
Manufacturing Authorisation issued on 14 August 1997 by the National Agency for Veterinary Medicinal Products, France.
L- awtorizzazzjoni tal- manifattura maħruġa fl’ 14 t’ Awissu 1997 mill- Aġenzija Nazzjonali għall - Prodotti Mediċinali Veterinarji, Franza.
Merial, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon, France
MERIAL, Laboratorju ta ’ Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon, France
Tetanus component:
Il- komponent tat- Tetnu:
Manufacturing Authorisation issued on 23/ 06/ 2003 by the National Agency for Veterinary Medicinal Products, France.
L- awtorizzazzjoni tal- manifattura maħruġa fit- 23/ 06/ 2003 mill- Aġenzija Nazzjonali għall- Prodotti Mediċinali Veterinarji, Franza.
Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 Saint- Priest France
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jinforma l- Kummissjoni Ewropea dwar il - pjanijiet għall- kummerċ għall- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
Pharmacologically active substance(s)
Sustanza farmakoloġikament
Animal Species
Speċi ta ’
Other provisions
Dispożizzjoniet
All food producing species
Kull speċi li tipproduċi l- ikel
CR No.
RK n.
Disodium phosphate
Fosfat tad- Disodium
Monopotassium phosphate
Fosfat tal- Monopotassju
2796/ 95
RK n. 2796/ 95
final product:
Sustanzi oħra fil- prodott finali:
Substance(s) Water for injections
Sustanza( i) Ilma għall- injezzjonijiet Carboner
MRL status Not falling within scope of CR No 2377/ 90
2377/ 90 Mhux fl- iskop tal- RK n.
Included in Annex I of CR 2377/ 90 for bovine and porcine species
RK 2377/ 90 għall - ispeċi bovini u porċini
Not considered pharmacologically active at the doses administered to the animals
farmakoloġika- ment attivi fid- dożi amministrati lill - annimali
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 17 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Outer package for 10 doses:
Pakkjar ewlieni għal 10 dożi:
10 vials of 1 dose
10 fjali ta ’ doża.
ProteqFlu-Te Suspension for injection for horses
Suspensjoni għall- injezzjoni għaż- żwiemel.
Influenza A/ equi-2/ Ohio/ 03 [H3N8] (vCP2242)....................................................... ≥ 5.3 log10 FAID50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)......................................... ≥ 5.3 log10 FAID50
Influenza A/ equi- 2 / Ohio/ 94 {H3N8} (vCP2242) …......................... > 5. 3 log 10 FAID 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} (vCP1533) ……………... > 5. 3 log 10 FAID50
Clostridium tetani toxoid............................................................................................................ .≥ 30 IU Adjuvant:
Clostridium tetani toxoid ……………………………………………………………… > 30 IU Adjuvant:
Carbomer..........................................................................................................................................
Carboner ………………………………………………………………………………… 4 mg
10 doses:
10 dożi:
Read the package leaflet before use.
Aqra l- fuljett tal- pakett qabel l- użu.
Intramuscular use.
Għall- użu fil- muskolu.
Withdrawal period: zero days.
Żmien ta 'Tiżmim: xejn
EXP Use immediately after opening.
DATA TA 'SKADENZA
Store and transport refrigerated 2°C – 8°C.
Aħżen u ttrasporta ġo friġġ (2˚C - 8˚C).
See section 7
Ara sezzjoni 7.
For animal treatment only to be supplied only on veterinary prescription
Għal Trattament ta ’ l- Annimali Biss: għandu jingħata biss bi preskrizzjoni medika veterinarja.
vial
{fjal}
ProteqFlu-Te
ProteqFlu- Te.
1 dose
doża
Intramuscular use
Għall- użu fil- muskolu.
ProteqFlu-Te Suspension for injection for horses
14/ 17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT ProteqFlu- Te Suspensjoni għall- injezzjoni għaż- żwiemel.
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France
MERIAL, Laboratorju Porte des Alpes, Rue de l’ Aviation, F- 69800 Saint Priest, France
Eur.
Influenza A/ equi- 2 / Ohio/ 94 {H3N8} virus rikombinat tal- Canarypox (vCP2242) > 5. 3 log 10 FAID * 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} virus rikombinat tal- Canarypox (vCP1533) > 5. 3 log 10 FAID* 50 * doża infettiva florexxenti ta ’ prova 50% Clostridium tetani toxoid........................................................................................... > 30 IU ** ** titlu ta ’ antikorp antitossiku indott wara tilqim ripetut fis- sera tal- fenek ta ’ l- indi skond il- Ph. Eur.
Carbomer..........................................................................................................................................
Carboner …………………………………………………………………………………………… 4 mg
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Immunizzazzjoni attiva ta ’ żwiemel ta ’ 4 xhur jew akbar kontra l- influwenza fiż- żwiemel sabiex tnaqqas sinjali kliniċi u tneħħija tal- virus wara infezzjoni, u kontra t- tetnu biex tipprevjeni l- mortalità.
• A transient swelling (max. diameter 5 cm) which regresses within 4 days may appear at the injection site. • Pain and local hyperthermia can occur in rare cases. • A slight increase in temperature (max.
• Jista ’ jkun hemm nefħa transitorja fil- post tal- injezzjoni (dijametru massimu ta ’ 5cm) li tinżel fi żmien erbat ijiem. • F’ każijiet rari jista ’ jkun hemm uġigħ u ipertermja lokali.
15/ 17 • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
15/ 17 • Għal ġurnata waħda u rarament għal tnejn, jista jkun hemm ħarira deni (massimu 1. 5˚C). • F’ ċirkostanzi eċċezzjonali, apatija u nuqqas ta ’ l- aptit jistgħu jiġu osservati l- għada tal - vaċċinazzjoni. • F’ ċirkostanzi eċċezzjonali, jista ’ jkun hemm reazzjoni ta ’ ipersensittività li tista ’ tirrikjedi kura sintomatika xierqa.
Shake the vaccine gently before use.
Ixxejkja ftit il- vaċċin rikostitwit qabel l- użu.
Intramuscular use (preferably in the neck region).
10.
• Keep out of the reach and sight of children. • Store and transport refrigerated 2°C – 8°C.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Aħżen u ttrasporta fil- friġġ 2°C – 8°C.
Protect from light. • Use immediately after opening. • Do not use after the expiry date stated on the label.
Ipproteġi mid- dawl. • Uża immedjatament wara li jiġi rikostitwit. • Tużax wara d- data tal- iskadenza fuq it- tikketta.
• Only healthy animals should be vaccinated. • Do not mix with any veterinary medicinal product. • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. • Can be used during pregnancy and lactation. • No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL ’ s inactivated vaccine against rabies. • Following the administration of overdoses of vaccine, no side-effects other than those described under “ Adverse reactions” have been observed.
• Annimali f’ saħħithom biss għandhom jiġu vaċċinati. • Tħallatx ma prodotti oħra mediċinali veterinarji ħlief mas- solvent provvdut. • F' kas li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew l- fuljett ta 'informazzjoni li jkun fih ġewwa. • Jista jintuża waqt it- tqala u żmien tal- ħalib. • L- ebda reazzjoni ma ġiet osservata meta l- vaċċin ġie amministrat simultanejament, iżda f’ sit separat, mal- vaċċin inattivat tal- Merial kontra r- rabbja.
16/ 17 13.
16/ 17 • Wara l- amministrazzjoni ta ’ dożi eċċessivi, l- ebda effett kollaterali ħlief dawk deskritti taħt “ Effetti mhux mixtieqa ” ma ġew osservati.
The vaccine stimulates active immunity against equine influenza and tetanus.
Il- vaċċin jistimola immunità kontra l- influwenza fiż- żwiemel.
The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
L- istrejns vCP2242 u vCP1533 tal- vaċċin huma virusijiet rikombinati tal- canarypox li jesprimu il - ġene hæmagglutinin HA mill- istrejns tal- virus tal- influwenza fiż- żwiemel A/ equi- 2/ Ohio/ 03 (strejn amerikan) u A/ equi- 2/ Newmarket/ 2/ 93 (strejn ewropew), rispettivament.
Veterinary medicinal product subject to prescription.
Kaxxa ta ’ 10 fjali ta ’ doża waħda.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas - CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is ProteqFlu?
X’ inhu ProteqFlu?
ProteqFlu is a vaccine for use in horses.
ProteqFlu huwa vaċċin għall- użu fiż- żwiemel.
It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively.
Huwa fih partijiet minn żewġ forom ta ’ influwenza (flu) taż- żwiemel, li ddaħħlu f’ żewġ vajrusijiet canarypox vector (ġarriera) rispettivament.
ProteqFlu is available as a suspension for injection.
ProteqFlu huwa disponibbli bħala sospensjoni għall- injezzjoni.
What is ProteqFlu used for?
Għalxiex jintuża ProteqFlu?
ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
ProteqFlu jintuża sabiex jitlaqqmu żwiemel ta ’ 4 xhur u aktar kontra l- influwenza taż- żwiemel u kontra t- tetnu.
The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Il- vaċċin inaqqas is- sinjali kliniċi tal- influwenza taż- żwiemel u l- eskrezzjoni (tixrid) tal- vajrus wara l- infezzjoni.
This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations.
Din għandha tkun segwita minn tilqima mill- ġdid 5 xhur wara u suċċessivament minn tilqimiet booster kull sena.
How does ProteqFlu work?
Kif jaħdem ProteqFlu?
ProteqFlu is a vaccine which was produced with the use of recombinant technology.
ProteqFlu huwa vaċċin li ġie prodott bl- użu ta ’ teknoloġija rikombinanti.
This means that a gene from two different equine influenza strains (A/ equi-2/ Ohio/ 03 and A/ equi- 2/ Newmarket/ 2/ 93) was inserted in two live canary pox vector viruses respectively which were made capable to produce parts of these influenza strains (specific proteins).
Dan ifisser li ġene minn żewġ forom differenti ta ’ influwenza taż- żwiemel (A/ equi- 2/ Ohio/ 03 u A/ equi - 2/ Newmarket/ 2/ 93) jiddaħħal f’ żewġ virusijiet ħajjin tal- canary pox vector rispettivament li jkunu saru kapaċi jipproduċu partijiet minn dawn il- forom ta ’ influwenza (proteini speċifiċi).
When ProteqFlu is given to horses, the animals’ immune system recognises the specific proteins from the equine influenza strains as ‘ foreign ’ and makes antibodies against them.
Meta ProteqFlu jingħata liż- żwiemel, is- sistema immunitarja tal- annimali tagħraf il- proteini speċifiċi mill- forom tal- influwenza taż- żwiemel bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium.
Is- sistema immunitarja mbagħad tkun tista ’ tagħmel dawn l - antikorpi protettivi iżjed malajr meta l- annimal ikun espost b’ mod naturali għall- virusijiet tal - influwenza taż- żwiemel u għall- batterju tat- tetnu.
This will help to protect against equine influenza.
Dan jgħin fil- protezzjoni kontra l- influwenza taż- żwiemel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu © European Medicines Agency, 2008.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu © European Medicines Ageency, 2008.
Reproduction is authorised provided the source is acknowledged.
Reproductin is authorised provided the source is acknowledged.
How has ProteqFlu been studied?
Kif ġie studjat ProteqFlu?
The safety of ProteqFlu was studied in several studies under laboratory and field conditions in a large number of horses, of all ages (from 1 month to 40 years) and physiological status (foals, non-pregnant and pregnant female adults and male adults).
Is- sigurtà ta ’ ProteqFlu ġiet studjata f’ diversi studji taħt kundizzjonijiet tal- laboratorju u tal - kamp f’ numru kbir ta ’ żwiemel ta ’ kull età (minn xahar sa 40 sena) u stat fiżjoloġiku (mħor, żwiemel nisa adulti tqal u mhux tqal u żwiemel irġiel adulti).
The effectiveness of ProteqFlu was studied in several studies under laboratory and field conditions.
L- effikaċja ta ’ ProteqFlu ġiet studjata f’ diversi studji taħt kundizzjonijiet tal- laboratorju u tal - kamp.
In studies under laboratory conditions, horses were challenged (infected) with equine influenza virus the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non vaccinated animals or vaccinated with a competitor product).
Is- sinjali kliniċi u l- eskrezzjoni tal- vajrus tal- influwenza wara l - isfida tqabblu bejn annimali mlaqqma u annimali ta ’ kontroll (annimali mhux imlaqqma jew annimali mlaqqma bi prodott kompetitur).
Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Ħafna mill- istudji saru bi ProteqFlu- Te, vaċċin li jipproteġi kontra żewġ forom ta ’ influwenza taż- żwiemel kif ukoll kontra t- tetnu.
The studies showed that ProteqFlu is an effective vaccine in horses from 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, 14 days after primary vaccination.
L- istudji wrew li ProteqFlu huwa vaċċin effettiv fi żmiemel minn 4 xhur ’ il fuq kontra l - influwenza taż- żwiemel biex inaqqas is- sinjali kliniċi u l- eskrezzjoni tal- vajrus wara l - infezzjoni, 14- il jum wara t- tilqima primarja.
What is the risk associated with ProteqFlu?
X’ inhu r- riskju assoċjat ma ’ ProteqFlu?
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
X’ inhu ż- żmien li għandu jitħalla jgħaddi qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall- konsum uman (perjodu ta ’ twaqqif)?
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm għandu jitħalla żmien jgħaddi qabel ma jkun jista ’ jittieħed ħalib mill- annimal biex jiġi kkunsmat mill- bniedem?
Page 2/ 3 ©EMEA 2008 Why has ProteqFlu been approved?
Paġna 2/ 3 ©EMEA 2008 Għaliex ġie approvat ProteqFlu?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the active immunisation of horses of 4 months of age or older 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) kkonkluda li l- benefiċċji ta ’ ProteqFlu huma akbar mir- riskji għall- immunizzazzjoni attiva taż- żwiemel ta ’ 4 xhur jew aktar kontra l- influwenza taż- żwiemel biex jitnaqqsu s- sinjali kliniċi u l- eskrezzjoni tal- vajrus wara l- infezzjoni, u kontra t- tetnu biex tiġi pprevenuta l- mortalità.
The Committee recommended that ProteqFlu be given a marketing authorisation.
Il- Kumitat irrakkomanda li ProteqFlu 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 f’ modulu 6 ta ’ dan l- EPAR.
Other information about ProteqFlu:
Informazzjoni oħra dwar ProteqFlu:
EU Number
Speċi li
Tradename
Ippakkjar
Pharmaceutical Form
Perijodu ta ’
Target Species
Ewropea
Packaging
amministra
Content
pakkett
Package Size
tiżmim
Withdrawal period
≥ 5. 3 log10 FAID50
≥ 5.3 log10 FAID50 to 7.6 log10 FAID50 for both vCP2242 and vCP1533 per dose
sa 7. 6 log10 FAID50 sia għal vCP2242 kemm għal vCP1533 għal kull doża
Intramuscular use
Għall- użu fil- muskolu
Vial (glass)
Fjala (tal - hġieġ)
1 dose (1 ml)
doża (1 ml)
ProteqFlu Suspension for injection for horses
ProteqFlu Suspensjoni għall- injezzjoni għaż- żwiemel.
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242)......... ...≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID*50 * Fluorescent assay infectious dose 50% Adjuvant:
Influenza A/ equi- 2 Ohio/ 03 {H3N8} virus rikombinat tal- Canarypox (vCP2242) > 5. 3 log 10 FAID * 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} virus rikombinat tal- Canarypox (vCP1533) > 5. 3 log 10 FAID* 50 * doża infettiva florexxenti ta ’ prova 50% Adjuvant:
Carbomer................................................................................................................................................ .4 mg
Carboner …………………………………………………………………………………………… 4 mg
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Immunizzazzjoni attiva ta ’ żwiemel ta ’ 4 xhur jew akbar kontra l- influwenza fiż- żwiemel sabiex tnaqqas sinjali kliniċi u tneħħija tal- virus wara infezzjoni.
Only healthy animals should be vaccinated.
Annimali f’ saħħithom biss għandhom jiġu vaċċinati.
• A transient swelling (max. diameter 5 cm) which regresses within 4 days may appear at the injection site. • Pain and local hyperthermia can occur in rare cases. • A slight increase in temperature (max.
Jista ’ jkun hemm nefħa transitorja fil- post tal- injezzjoni (dijametru massimu ta ’ 5cm) li tinżel • fi żmien erbat ijiem.
1.5 °C) may occur for 1 day, exceptionally 2 days. • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
F’ każi rari jista ’ jkun hemm uġigħ u ipertermja lokali. • Għal ġurnata waħda u rarament għal tnejn, jista jkun hemm ħarira deni (massimu 1. 5˚C). • F’ ċirkostanzi eċċezzjonali, apatija u nuqqas ta ’ l- aptit jistgħu jiġu osservati l- għada tal - • vaċċinazzjoni.
Administer one dose (1ml), by intramuscular injection, preferably in the neck region, according to the following schedule: • Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later • Revaccination:
It- tieni kors:
5 months after primary vaccination course followed by annual booster injections 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 5-6 months of age and 4-6 weeks later followed by revaccination).
F’ każ li jiżdied ir- riskju ta ’ infezzjoni jew jekk ma jkunx hemm kolostrum suffiċjenti, injezzjoni oħra tista ’ tingħata ta ’ 4 xhur segwita mill- programm komplet ta ’ tilqim (l- ewwel kors ta ’ tilqim ta ’ 5 – 6 xhur u 4 – 6 ġimgħat wara segwit mit- tieni kors).
QI05AD02
Q105AD02
The vaccine stimulates active immunity against equine influenza.
Il- vaċċin jistimola immunità kontra l- influwenza fiż- żwiemel.
The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
3/ 17 L- istrejns vCP2242 u vCP1533 tal- vaċċin huma virusijiet rikombinati tal- canarypox li jesprimu il- ġene hæmagglutinin HA mill- istrejns tal- virus tal- influwenza fiż- żwiemel A/ equi- 2 / Ohio/ 03 (strejn amerikan) u A/ equi- 2/ Newmarket/ 2/ 93 (strejn ewropew), rispettivament.
27 months.
27 il- xahar.
MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 Saint- Priest France
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jinforma l- Kummissjoni Ewropea dwar il - pjanijiet għall- kummerċ għall- prodott mediċinali awtorizzat b’ din id- deċisjoni.
Other provisions
Dispożizzjonijiet Oħra
All food producing species
Kull speċje li jipproduċi l- ikel
Disodium phosphate
Fosfat tad- dissodium
Substance(s) Water for injections
Sustanza (i) Ilma għall- injezzjonijiet Carboner
Included in Annex I of CR 2377/ 90 for bovine and porcine species
2377/ 90 għall- ispeċi bovini u porċini
Not considered pharmacologically active at the doses administered to the animals
farmakoloġika- ment attivi fid - dożi amministrati lill- annimali
Influenza A/ equi-2/ Ohio/ 03 [H3N8] (vCP2242)............................................................. .≥ 5.3 log10 FAID50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)............................................. ...≥ 5.3 log10 FAID50
Influenza A/ equi- 2 Ohio/ 94 {H3N8} (vCP2242) …......................... > 5. 3 log 10 FAID 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} (vCP1533) ……………... > 5. 3 log 10 FAID50
Carbomer................................................................................................................................................ .4 mg
Carboner ………………………………………………………………………………… 4 mg
See section 7.
Ara sezzjoni 7.
{vial}
{fjal}
ProteqFlu Suspension for injection for horses
ProteqFlu Suspensjoni għall- injezzjoni għaż- żwiemel
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France
MERIAL, Laboratoire Porte des Alpes, Rue de l’ Aviation, F- 69800 Saint Priest, France
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242)......... ...≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID*50 * Fluorescent assay infectious dose 50% Adjuvant:
Influenza A/ equi- 2 / Ohio/ 03 {H3N8} virus rikombinat tal- Canarypox (vCP2242) … > 5. 3 log 10 FAID * 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 {H3N8} virus rikombinat tal- Canarypox (vCP1533) > 5. 3 log 10 FAID* 50 Adjuvant:
1.5 °C) may occur for 1 day, exceptionally 2 days. • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
F’ każi rari jista ’ jkun hemm uġigħ u ipertermja lokali. • Għal ġurnata waħda u rarament għal tnejn, jista jkun hemm ħarira deni (massimu 1. 5˚C). •
15/ 17 • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
15/ 17 F’ ċirkostanzi eċċezzjonali, apatija u nuqqas ta ’ l- aptit jistgħu jiġu osservati l- għada tal - • vaċċinazzjoni.
• Keep out of the reach and sight of children. • Store and transport refrigerated 2°C – 8°C.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Aħżen u ttrasporta fil- friġġ 2°C – 8°C.
Protect from light. • Use immediately after opening. • Do not use after the expiry date stated on the label.
Ipproteġi mid- dawl. • Uża immedjatament wara li jiġi rikostitwit. • Tużax wara d- data tal- iskadenza fuq it- tikketta. •
• Only healthy animals should be vaccinated. • Do not mix with any veterinary medicinal product. • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. • Can be used during pregnancy and lactation. • No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL ’ s inactivated vaccine against rabies. • Following the administration of overdoses of vaccine, no side-effects other than those described under “ Adverse reactions” have been observed.
Wara l- amministrazzjoni ta ’ dożi eċċessivi, l- ebda effett kollaterali ħlief dawk deskritti taħt • “ Effetti mhux mixtieqa ” ma ġew osservati.
The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
L- istrejns vCP2242 u vCP1533 tal- vaċċin huma virusijiet rikombinati tal- canarypox li jesprimu il- ġene hæmagglutinin HA mill- istrejns tal- virus tal- influwenza fiż- żwiemel A/ equi- 2 / Ohio/ 03 (strejn amerikan) u A/ equi- 2/ Newmarket/ 2/ 93 (strejn ewropew), rispettivament.
What is Pruban?
X' inhu Pruban?
Pruban is a white to off-white cream containing resocortol butyrate as the active substance.
Pruban huwa krema bejn bajda u bajdanija li fiha s- sustanza attiva resocortol butyrate.
Resocortol butyrate is a corticosteroid.
Resocortol butyrate huwa kortikosterojde.
What is Pruban used for?
Għal xiex jintuża Pruban?
Pruban is applied to the skin for the treatment of small areas of sudden onset moist irritated skin (acute moist dermatitis in dogs.
Pruban huwa applikat fuq il- ġilda għat- trattament ta 'każijiet għal għarrieda ta' irritazzjoni umda ta 'żoni żgħar tal- ġilda (dermatite umda akuta) fil- klieb.
The cream should be applied to the area twice daily for 7-14 days.
Il- krema għandha tiġi applikata fuq iż- żona darbtejn kuljum għal 7- 14- il ġurnata.
For details on dosing, please see the Package Leaflet.
Għad- dettalji dwar id- dożaġġ, jekk jogħġbok ara l- Fuljett ta 'Tagħrif.
How does Pruban work?
Kif jaħdem Pruban?
Most cases of acute moist dermatitis are due to complications of flea bite hypersensitivity, although they may also be caused by other ectoparasites, allergic skin diseases, anal sac problems or foreign bodies (such as grass awns).
F' ħafna każijiet id- dermatite umda akuta hija konsegwenza ta 'ipersensittività tal- qarsa tal- briegħed, iżda tista' wkoll tkun ikkawżata minn ektoparassiti oħra, minn mard tal- ġilda tat- tip allerġiku, minn problemi tal- glandoli anali (anal sac) jew minn korpi li jidħlu minn barra (pereżempju ta 'oriġini veġetali).
Once the skin is irritated, an itch-scratch cycle starts and this may lead to lesions that are quite severe in appearance within a few hours.
Ladarba l- ġilda hija irritata, jibda ċiklu ta 'ħakk u grif li jista' jwassal għal leżjonijiet li fi ftit sigħat jieħdu dehra pjuttost gravi.
Resocortol butyrate belongs to the group of glucocorticosteroids which have anti-inflammatory effects.
Resocortol butyrate jappartjeni għall- grupp tal- glukokortikosterojdi li għandhom effetti antinfjammatorji.
Pruban reduces the inflammation of the skin locally.
Pruban inaqqas l- infjammazzjoni tal- ġilda lokalment.
How has Pruban been studied?
Kif ġie studjat Pruban?
Several studies were performed in rats, rabbits and dogs to examine the safety of Pruban.
Twettqu bosta studji fuq il- firien, il- fniek u l- klieb biex jeżaminaw is- sigurtà ta 'Pruban.
The trial showed low level irritation, but no toxicity.
Twettqet ukoll prova fuq il- bnedmin, li wriet livell baxx ta 'irritazzjoni, iżda l- ebda tossiċità.
The results of these studies are reflected in the contraindications.
Ir- riżultati ta 'dawn l- istudji huma riflessi fil- kontraindikazzjonijiet.
What benefit has Pruban shown during the studies?
Liema benefiċċju wera Pruban waqt l- istudji mwettqa?
In the studies of dogs suffering from acute moist dermatitis almost 80% of cases were cured or improved following treatment for 7 to 14 days.
Fl- istudji fuq il- klieb li jbatu minn dermatite umda akuta, madwar 80% tal- każijiet waslu għal fejqan jew titjib wara trattament li dam minn 7 għal 14- il ġurnata.
What is the risk associated with Pruban?
X' inhu r- riskju assoċjat ma 'Pruban?
Pruban should not be used in dogs with extensive, infected or ulcerated skin lesions or in animals suffering from Cushing’ s syndrome (hyperadrenocorticism).
Pruban ma għandux jintuża fi klieb b' leżjonijiet tal- ġilda estiżi, infettati jew b' ulċeri jew f' annimali li jbatu mis- sindromu ta 'Cushing (iperadrenokortiċiżmu).
Pruban should not be used in puppies under 6 months of age.
Pruban ma għandux jintuża fi ġriewi li għandhom inqas minn 6 xhur.
Since glucocorticosteroids can slow growth, the use of the product in young, growing animals should be well controlled and large lesions should not be treated.
Billi l- glukokortikosterojdi jistgħu jikkawżaw ittardjar tat- tkabbir, għandu jkun ikkontrollat sew l- użu f' annimali ta 'età żgħira li qegħdin fil- fażi li jikbru u ma għandhomx jiġu ttrattati l- leżjonijiet estiżi.
Lesions should be monitored closely for signs of infection.
Il- leżjonijiet għandhom jiġu mmonitorjati mill- qrib biex jirrapportaw is- sinjali ta 'infezzjoni.
In case of diabetes mellitus, the potential systemic effects of the product may influence blood glucose concentrations.
F' każ ta 'dijabete mellitu, l- effetti sistemiċi potenzjali tal- prodott jistgħu jkollhom riperkussjonijiet fuq il - konċentrazzjonijiet tal- glukożju fid- demm.
On rare occasions, hyperaemia of the treated area has been observed.
F' każijiet rari ġiet osservata iperemija fiż- żona ttrattata.
Do not use in dogs for breeding or in pregnant or lactating bitches.
Tużax fuq il- klieb tat- tgħammir jew fuq klieb ħobla jew li jreddgħu.
The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing and secondary infections.
Ġie rikonoxxut li l- użu terapewtiku ta 'dawn is- sustanzi fil- bniedem jikkaġuna effetti sekondarji lokali bħal tislit tal- ġilda, dgħufija tal- ġilda, ittardjar fil- proċessi ta' fejqan u infezzjonijiet sekondarji.
Why has Pruban been approved?
Għaliex ġie approvat Pruban?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pruban exceeded the risks for the treatment of acute localised moist dermatitis in dogs, and recommended that Pruban be granted a market authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta 'Pruban huma ogħla mir- riskji għat- trattament tad- dermatite umda akuta lokalizzata fil- klieb u rrakkomanda li tinħareġ l- awtorizzazzjoni għat- tqegħid fis- suq għal Pruban.
Other information about Pruban:
Aktar tagħrif dwar Pruban:
The European Commission granted a marketing authorisation valid throughout the European Union, for Pruban to Intervet International B. V. on 16 November 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Pruban lil Intervet International B. V. fis- 16 ta 'Novembru 2000.
The authorisation was subsequently renewed.
L- awtorizzazzjoni ġiet sussegwentement imġedda.
What is Purevax FeLV?
X’ inhu Purevax FeLV?
Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Purevax FeLV huwa vaċċin li fih vajrus tal- lewkimja tal- qtates (FeLV) vajrus rekombinanti canarypox (vCP97).
Purevax FeLV is presented as a suspension for injection.
Purevax FeLV huwa ppreżentat bħala sospensjoni għal injezzjoni.
What is Purevax FeLV used for?
Għal xiex jintuża FeLV?
Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus.
Purevax FeLV jintuża biex jitlaqqmu qtates mill- età ta ’ tmien ġimgħat kontra l- lewkimja tal - qtates, marda li taffettwa s- sistema immunitarja ikkaġunata minn tip ta ’ vajrus magħruf bħala retrovirus.
The vaccine is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.
Il- vaċċin jintuża biex jimpedixxi s- sintomi tal- marda u jimpedixxi milli FeLV jibqa ’ fid- demm.
A 1 ml dose of Purevax FeLV is injected under the skin.
Doża ta ’ 1 ml ta ’ Purevax FeLV hija injettata taħt il- ġilda.
The first injection should be given in cats aged at least eight weeks, with a second injection three to five weeks later.
L- ewwel injezzjoni għandha tingħata fi qtates ta ’ età ta ’ mill- inqas tmien ġimgħat, bit- tieni injezzjoni tlieta sa ħames ġimgħat aktar tard.
Immunity starts at the latest two weeks after the second injection and lasts for a year.
L- immunità tibda ta ’ mill- inqas ġimagħtejn wara t- tieni injezzjoni u sservi sena.
The cats should be revaccinated every year.
Il- qtates għandhom jerġgħu jitlaqqmu kull sena.
How does Purevax FeLV work?
Kif jaħdem Purevax FeLV?
Purevax FeLV is a vaccine.
Purevax FeLV huwa vaċċin.
Vaccines work by priming the immune system (the body ’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi jippreparaw is- sistema immunitarja (id - difiżi naturali tal- ġisem) biex tiddefendi lilha nfisha kontra l- mard.
Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘ recombinant DNA technology’.
Purevax FeLV fih ġeni mill- FeLV sotto- grupp A imsejjaħ env u gag li ddaħħlu f’ vajrus vektor (carrier) imsejjaħ canarypox bl- użu ta ’ ‘ teknoloġija rekombinanti tad- DNA ’.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Il- vajrusijiet canarypox ma jinfirxux jew ma jimmultiplikawx fil- qattus iżda jipproduċu proteini mill- ġeni FeLV.
When a cat is given the vaccine, the immune system recognises the FeLV proteins as ‘ foreign’ and makes antibodies against them.
Meta l- qattus jingħata l- vaċċin, is- sistema immunitarja tagħraf il- proteini bħala ‘ barranin ’ u tagħmel antikorpi kontra tagħhom.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the FeLV.
Fil- futur, is- sistema immunitarja tkun tista ’ tipproduċi antikorpi aktar malajr meta tkun esposta għall- FeLV.
The antibodies will help to protect against the disease caused by the virus.
L- antikorpi jgħinu biex jipproteġu kontra l- mard ikkaġunat mill- vajus.
Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus:
Tilqim kontra FeLV sotto- grupp A jagħti protezzjoni sħiħa kontra t- tliet sotto- gruppi tal- virus:
A, B and C.
A, B u Ċ.
Reproduction is authorised provided the source is acknowledged How has Purevax FeLV been studied?
Reproduction is authorised provided the source is acknowledged Kif ġie studjat Purevax FeLV?
The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV.
L- effikaċja tà ta ’ Purevax FeLV ġiet studjata f’ diversi provi f’ kondizzjonijiet tal- laboratorju fejn qtates kienu mlaqqma u infettati b’ FeLV.
In the field, efficacy has been studied in one main study of kittens aged eight weeks or older, in which the effects of Purevax FeLV were compared with those of another vaccine against FeLV.
L- effikaċja ġiet studjata fil- kamp fi studju wieħed ewlieni fil- frieħ tal- qtates ta ’ etajiet ta ’ tmien ġimgħat jew akbar, f’ liema l- effetti ta ’ Purevax FeLV tqabblu ma ’ dawk ta ’ vaċċin kontra FeLV ieħor.
The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV.
Il- frieħ tal- qtates imlaqqma inżammu għal sa 28 ġimgħa ma ’ grupp ta ’ frieħ tal- qtates li kienu infettati b’ FeLV.
In all trials, the main measure of effectiveness was the presence of antibodies against the virus and infectious FeLV in the vaccinated kittens’ blood.
Fil- provi kollha, il- miżura ewlenija ta ’ l- effikaċja kienet il- preżenza ta ’ antikorpi kontra l- vajrus u FeLV infettiv fid- demm tal- frieħ tal- qtates imlaqqma.
What benefit has Purevax FeLV shown during the studies?
X’ benefiċċju wera Purevax FeLV waqt l- istudji?
Purevax FeLV vaccine provided protection against FeLV infection.
Il- vaċċin Purevax FeLV ipprovda protezzjoni kontra infezzjoni FeLV.
The first evidence of FeLV infection occurred after six weeks in only a few of the kittens vaccinated with Purevax FeLV.
L- ewwel evidenza ta ’ infezzjoni FeLV seħħet wara sitt ġimgħat fi ftit biss mill- frieħ tal- qtates imlaqqma b’ Purevax FeLV.
Infection was seen from four weeks in non-vaccinated animals.
L- infezzjoni dehret minn erba ’ ġimgħat f’ annimali mhux imlaqqma.
What is the risk associated with Purevax FeLV?
X’ inhu r- riskju assoċjat ma ’ Purevax FeLV?
A temporary small nodule (hard lump) may appear at the site of injection.
Għoqda żgħira (għoqda iebsa) temporanja tista ’ tfeġġ fis- sit ta ’ l- injezzjoni.
This usually disappears within one to four weeks.
Din ġeneralment tisparixxi fi żmien ġimgħa sa erba ’ ġimgħat.
Temporary lethargy (listlessness) and hyperthermia (increased body temperature) may occur for one day, exceptionally for two days.
Letarġija (nuqqas kbir ta ’ enerġija) u ipertermija (żieda fit- temperatura tal- ġisem) tista ’ sseħħ għal jum wieħed, eċċezzjonalment għal jumejn.
For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Purevax FeLV, ara l- Fuljett ta ’ Tagħrif.
Purevax FeLV should not be used in pregnant cats.
Purevax FeLV m’ għandux jintuża fi qtates tqal.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet għal persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- 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 tinjetta lilek innifsek b’ mod aċċidentali fittex parir mediku minnufih u uri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Purevax FeLV been approved?
Għaliex ġie approvat Purevax FeLV?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benfiċċji ta ’ Purevax FeLV jegħlbu r- riskji ta ’ tilqim attiv ta ’ qtates ta ’ tmien ġimgħat jew akbar kontra l- lewkimja tal- qtates għall- prevenzjoni ta ’ vajrimja persistenti u sinjali kliniċi ta ’ mard relatat, u irrakomanda li Purevax FeLV jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn ir- riskju u l- benefiċċju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR.
Other information about Purevax FeLV:
Tagħrif ieħor dwar Purevax FeLV:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Purevax FeLV valida fl- Unjoni Ewropea kollha lil MERIAL fit- 13 ta ’ April 2000.
The marketing authorisation was renewed on 18 April 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 18 ta ’ April 2005.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il - prodott jista ’ jinstab fuq it- tikketta/ il- pakkett ta ’ barra.
This summary was last updated on 24 October 2007.
Dan is- sommarju ġie aġġornat l- aħħar fl- 24 ta ’ Ottubru 2007.
EU Number
Numru ta ’ l - Unjoni Europea
Target Species
Speċi fuq min ser jintuża
Route of administration
Mod ta ’ am - ministrazzjoni
Package Size
Daqs talpakkett
FeLV recombinant Canarypox virus (vCP97) ≥ 10 7.2 CCID50 (cell culture infective dose)
10 dożi
subcutaneous route
Suspensjon
10 doses
kaxxa ta ’ 10
Suspension for injection
i għall - injezzjoni
Box of 10 x 1 bottles.
x flixkun.
Not applicable
Mhux
FeLV recombinant Canarypox virus (vCP97) ≥ 10 7.2 CCID50)
FeLV vajrus
subcutaneous route
Taħt il- ġilda
20 doses
20 doża
Suspension for injection
Suspensjon
Box of 20 x 1 bottles
kaxxa ta ’ 20
Not applicable
applikabbli
FeLV recombinant Canarypox virus (vCP97) ≥ 10 7.2 CCID50
FeLV vajrus
50 doses
50 doża
Box of 50 x 1 bottles
kaxxa ta ’ 50
Active substance(s) FeLV recombinant Canarypox virus (vCP97)......... ≥ 10 7.2 CCID50 (cell culture infective dose 50%) For a full list of excipients, see section 6.1.
FeLV vajrus rikombinant tal- Canarypox (vCP97)...... > 10 7. 2 CCID50 (doża infettiva tas- cell culture 50%) Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.