qanastek/EMEA-V3 huggingface dataset:
It is therefore recommended that dogs should be allowed to reach puberty before treatment with the product is initiated.
Għalhekk huwa rakkomandat li l- klieb jitħallew jilħqu l- pubertà qabel ma jinbeda trattament bil- prodott.
Data demonstrates that treatment with the product will reduce the libido of the dog, but other behavioural changes (e. g. male-associated aggression) have not been investigated.
It- tagħrif juri li trattament bil- prodott inaqqas il- libido tal- kelb, iżda bidliet oħra fl- imġiba (eż. aggressjoni relatata mar- raġel) ma ġewx mistħarrġa.
No adverse reactions have been observed following simultaneous subcutaneous administration of up to 10 implants.
L- ebda reazzjonijiet avversi ma ġew osservati wara t- tqegħid sa 10 impjanti f’ salt taħt il- ġilda sa 10 impjanti.
The actuator can be re-used.
Il- planġer jista 'jerġa ’ jintuża.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediċinali veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
EMEA/ V/ C/ 038 EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
EMEA/ V/ C/ 038 RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEA (EPAR)
What is Suvaxyn Aujeszky 783 + O/ W?
X’ inhu Suvaxyn Aujeszky 783 + O/ W?
Suvaxyn Aujeszky 783 + O/ W is a vaccine that contains a live attenuated (weakened) form of Aujeszky’ s disease virus strain NIA3-783.
Suvaxyn Aujeszky 783 + O/ W huwa vaċċin li fih forma ħajja iżda dgħajfa tar- razza NIA3- 783 tal- vajrus li jikkawża l- marda ta ’ Aujeszky.
Suvaxyn Aujeszky 783 + O/ W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.
Suvaxyn Aujeszky 783 + O/ W hu trab u solvent li jitħalltu biex jifformaw emulsjoni (taħlita ta ’ likwidi b’ bażi ta ’ ilma u żejt) għall- injezzjoni.
What is Suvaxyn Aujeszky 783 + O/ W used for?
Għal xiex jintuża Suvaxyn Aujeszky 783 + O/ W?
Suvaxyn Aujeszky 783 + O/ W is used to vaccinate pigs from the age of 10 weeks against Aujeszky’ s disease, an illness similar to rabies that is caused by a herpesvirus.
Suvaxyn Aujeszky 783 + O/ W jintuża għat- tlaqqim tal- ħnieżer mill- età ta ’ 10 ġimgħat kontra l- marda ta ’ Aujeszky, marda li tixbah lir- rabja li tiġi kkawżata minn herpesvirus.
It prevents death and symptoms of the disease and reduces the shedding of the virus.
Jipprevjeni l - mewt u s- sintomi tal- marda u jnaqqas it- tixrid tal- vajrus.
Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/ W can also result in immunity in the pig’ s offspring.
It- tilqim b’ Suvaxyn Aujeszky 783 + O/ W ta ’ ħnieżer nisa li qatt ma jkunu welldu u ta ’ ħnieżer nisa li jkunu welldu jista ’ jwassal għal immunità fil- frieħ tal- ħnieżer.
Suvaxyn Aujeszky 783 + O/ W is given as two 2-ml injections into the muscle of the neck behind the ear, three to four weeks apart.
Suvaxyn Aujeszky 783 + O/ W jingħata f’ żewġ injezzjonijiet ta ’ 2- ml fil- muskolu ta ’ l- għonq wara l- widna, bi spazju ta ’ bejn tlieta u erba ’ ġimgħat bejniethom.
Immunity starts after three weeks and lasts for three months.
L- immunità tibda wara tliet ġimgħat u sservi tliet xhur.
Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth.
Ħnieżer nisa tat- tnissil għandhom jitlaqqmu mill- ġdid qabel ma jitgħammru jew f’ kull tqala, bejn tlieta u sitt ġimgħat qabel ma jwelldu.
Breeding boars (male pigs) should be revaccinated every six months.
Ħnieżer irġiel tat - tnissil għandhom jitlaqqmu mill- ġdid kull sitt ġimgħat.
To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months.
Biex titlaqqam merħla sħiħa, għandha tingħata doża waħda lil kull ħanżir u ħanżira tat- tnissil kull erba ’ xhur.
How does Suvaxyn Aujeszky 783 + O/ W work?
Kif jaħdem Suvaxyn Aujeszky 783 + O/ W?
Suvaxyn Aujeszky 783 + O/ W is a vaccine.
Suvaxyn Aujeszky 783 + O/ W hu vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif jiddefendu lilhom infushom mill- mard.
Suvaxyn Aujeszky 783 + O/ W contains small amounts of a weakened form of the virus that causes Aujeszky’ s disease.
Suvaxyn Aujeszky 783 + O/ W ikun fih ammonti żgħar tal- vajrrus li jikkawża l- marda ta ’ Aujeszky f’ forma dgħajfa.
The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker.
Il- vajrus ikun ġie modifikat ġenetikament: tkun tneħħietlu l- ġene li tagħmlu kapaċi jipproduċi enzim magħruf bħala thymidine kinase) u huwa dan li jdgħajfu.
The vaccine also contains ‘ adjuvants ’ (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.
Il- vaċċin ikun fih ukoll ‘ adjuvant ’ (kompost li jkun fih l- aluminju kif ukoll żejt minerali, emulsifikant u deterġent) biex jistimula rispons aħjar.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Meta ħanżir jingħata t- tilqima, is- sistema immunitajra tagħraf lill- vajrus imdgħajjef bħala ‘ barrani ’ u jagħmel l- antikorpi kontriehom. ’ Il quddiem, is- sistema immunitarja tkun tista ’ tipproduċi antikorpi iktar malajr meta tiġi esposta għall- vajrus mill- ġdid.
This protects the pigs against the disease.
Dan jipproteġi lill - ħnieżer mill- marda.
The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk.
L- antikorpi jgħaddu wkoll mill- omm għall- frieħ mill- kolostru (il- ħalib tal - bidu) u mill- ħalib.
This enables the piglets of vaccinated pigs to be protected against the disease.
Dan jippermetti lill- frieħ tal- ħnieżer li jitlaqqmu kontra l- marda.
(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 How has Suvaxyn Aujeszky 783 + O/ W been studied?
(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 Kif ġie studjat Suvaxyn Aujeszky 783 + O/ W?
The effectiveness of Suvaxyn Aujeszky 783 + O/ W has been studied in a large number of pigs in several farms in studies lasting around two years.
L- effikaċja ta ’ Suvaxyn Aujeszky 783 + O/ W ġiet studjata f’ għadd kbir ta ’ ħnieżer f’ ħafna rziezet f’ diversi studji li damu madwar sentejn.
The herds of pigs were monitored for signs of infection with the type of Aujeszky’ s disease virus that is can be caught in the field.
L- imrieħel tal- ħnieżer ġew sorveljati għal sinjali ta ’ infezzjoni bit- tip ta ’ vajrus tal- marda ta ’ Aujeszky li jista ’ jinstab fl- ambjent naturali.
The studies compared the levels of infection in vaccinated and unvaccinated pigs.
L- istudji qabblu l- livelli ta ’ injezzjoni fi ħnieżer imlaqqma u mhux imlaqqma.
What benefit has Suvaxyn Aujeszky 783 + O/ W shown during the studies?
X’ inhu l- benefiċċju ta ’ Suvaxyn Aujeszky 783 + O/ W li ntwera f’ dawn l- istudji?
Suvaxyn Aujeszky 783 + O/ W was effective at preventing infection with the virus.
Suvaxyn Aujeszky 783 + O/ W kien effettiv fil- prevenzjoni ta ’ infezzjoni bil- vajrus.
After vaccination, the number of pig herds with signs of infection fell significantly, as did the number of infected pigs within the herds.
Wara t - tilqima, l- għadd ta ’ mrieħel tal- ħnieżer b’ sinjali ta ’ infezzjoni u l- għadd ta ’ ħnieżer infettati fl - imrieħel naqsu b’ mod sinjifikanti.
There was no change in the infection rates in the pigs that were not vaccinated.
Ma kienx hemm tibdil fir- rati ta ’ infezzjoni fil- ħnieżer li ma tlaqqmux.
What is the risk associated with Suvaxyn Aujeszky 783 + O/ W?
X’ inhu r- riskju assoċjat ma ’ Suvaxyn Aujeszky 783 + O/ W?
In up to a half of pigs being vaccinated, a slight temporary reaction can occur at the site of injection.
F’ mhux iktar minn nofs il- ħnieżer imlaqqma, kien hemm reazzjoni temporanja fis- sit ta ’ l - injezzjoni.
This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks.
Din jista ’ jkollha dijametru ta ’ mhux iktar minn 2 ċm wara l- ewwel injezzjoni u sa 5ċm wara t- tieni waħda, iżda ġeneralment jisparixxu fi żmien tliet ġimgħat.
An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.
F’ xi ftit mill - ħnieżer jista ’ jkun hemm żieda fit- temperatura sa madwar 40. 5°C, li ddum sa jumejn.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Xi prekawzjonijiet iridu jittieħdu mill- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l - annimal?
Wash and disinfect hands and equipment after use.
Aħsel u ddiżinfetta idejk u t- tagħmir wara li tużah.
Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger.
Injezzjoni aċċidentali tista ’ tikkawża nefħa u uġigħ sever, partikolarment jekk il- vaċċin jiġi injettat f’ seba ’ jew ġog.
In case of accidental injection, seek prompt medical advice and show the Package Leaflet to the doctor.
Fil- każ ta ’ injezzjoni aċċidentali, itlob parir mediku immedjatament u uri l- Fuljett lit- tabib.
If pain persists for more than 12 hours after examination, seek medical advice again.
Jekk l- uġigħ jippersisti għal iktar minn 12- il siegħa wara l- eżaminazzjoni, erġa ’ itlob parir mediku.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi żmien qabel ma l- annimal jinqatel u l- laħam ikun jista ’ jintuża għall - konsum mill- bniedem (withdrawal period)?
The withdrawal period is zero days.
Il- withdrawal period hu żero jiem.
Why has Suvaxyn Aujeszky 783 + O/ W been approved?
Għaliex ġie approvat Suvaxyn Aujeszky 783 + O/ W?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/ W exceed the risks for the active and passive immunisation of pigs to prevent or reduce the mortality and clinical signs of Aujeszky’ s disease and to reduce the excretion of Aujeszky’ s disease field virus, and recommended that Suvaxyn Aujeszky 783 O/ W be given a marketing authorisation.
Hu rrakkomanda li Suvaxyn Aujeszky 783 O/ W jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Suvaxyn Aujeszky 783 + O/ W:
Tagħrif ieħor dwar Suvaxyn Aujeszky 783 + O/ W:
The European Commission granted a marketing authorisation valid throughout the European Union for Suvaxyn Aujeszky 783 + O/ W to Fort Dodge Animal Health Holland on 7 August 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Suvaxyn Aujeszky 783 + O/ W lil Fort Dodge Animal Health Holland fis- 7 ta ’ Awwissu 1998.
The marketing authorisation was renewed on 7 August 2003.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 7 ta ’ Awwissu 2003.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta / pakkett ta ’ barra.
Tradename Strength
Qawwa
Pharmaceutical Form
Għamla
Target Route of species administration
Speċi li fuqhom
Packaging
Mod ta ’
Content Package size
Ippakkjar
Withdrawal period
Kontenut Daqs tal -
EU/ 2/ 98/ 009/ 001
Perjodu
Suvaxyn
kummerċjali
Live attenuated
Farmaċewtika għandu jintuża l- prodott
Emulsion for
Amministrazzj oni
Pigs
pakkett
Intramuscular
ta ’ Tiżmim
7 ml glass vial (freeze- 1 x 10
EU/ 2/ 98/ 009/ 001
Aujeszky’ s Disease Virus, strain NIA3- 783: ≥ 105.2 CCID50* per dose.
Virus ħaj inattivat Emulsjoni għall - Majjali tal- Marda Aujeszky, injezzjoni wara razza NIA 3- 783: ≥ r- rikostituzzjoni 10 5. 2 CCID50 * għal kull doża.
injection after reconstitution
Użu għal ġol - muskoli
dried component) & doses 22 ml glass bottle (liquid component)
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 22 ml (komponent likwidu)
doses and 1 bottle for reconstitution
Fjala waħda ta ’ 10 dożi u flixkun wieħed għar - rikostituzzjoni
dried component) & doses 105 ml glass bottle (liquid component)
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 105 ml (komponent likwidu)
doses and 1 bottle for reconstitution
Fjala waħda Xejn ta ’ 50 doża u flixkun wieħed għar - rikostituzzjoni
Live attenuated
Virus ħaj inattivat Emulsjoni għall - Majjali tal- Marda Aujeszky, injezzjoni wara razza NIA 3- 783: ≥ r- rikostituzzjoni 10 5. 2 CCID50 * għal kull doża.
Intramuscular
Użu għal ġol - muskoli
7 ml glass vial (freeze-
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 210 ml (komponent likwidu)
1 x 100
1 x 100 doża
1 vial of 100 0 days
EU/ 2/ 98/ 009/ 004
dried component) & doses 210 ml glass bottle (liquid component)
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 22 ml (komponent likwidu)
10 x 10
10 x 10 dożi
10 vials of 10 0 days
10 fjali ta ’ 10 Xejn dożi u 10 fliexken għar - rikostituzzjoni
dried component) & doses 22 ml glass bottle (liquid component)
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 105 ml (komponent likwidu)
10 x 50
10 x 50 doża
doses and 10 bottles for reconstitution
10 fjali ta ’ 50 Xejn doża u 10 fliexken għar - rikostituzzjoni
dried component) & 100 210 ml glass bottle (liquid component)
Fjala tal- ħġieġ ta ’ 7 ml (komponent imnixxef bil- friża) & flixkun tal - ħġieġ ta ’ 210 ml (komponent likwidu)
doses and 10 bottles for reconstitution
10 x 100 doża
* CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
10 fjali ta ’ 100 Xejn doża u 10 fliexken għar - rikostituzzjoni
Suvaxyn Aujeszky 783 + O/ W, powder and solvent for emulsion for injection.
Għall- majjali
CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Sustanza( i) Attiv/ i: Virus ħaj inattivat tal- Marda Aujeszky, razza NIA 3- 783: ≥ 10 5. 2 TCID50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID 50 = il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulat.
One dose of 2 ml contains Adjuvants:
Sustanza miżjuda:
Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Excipient
Aluminium hydroxide Żejt Minerali (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80)
2.1 mg 425 µl 46 µl 17 µl
425 µl 46 µl 17 µl
Powder and solvent for emulsion for injection
Trab u solvent għall- emulsjoni għall- injezzjoni.
Pigs
Majjali.
4.2 Indications for use, specifying the target species
4. 2 Indikazzjoni għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.
Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Immunizzazzjoni attiva tal- majjali mill- eta ’ ta ’ 10 ġimgħat sabiex tiġi evitata l- mortalita ’ u s- sinjali kliniċi tal- Marda Aujeszky u sabiex jitnaqqas it- tixrid tal- virus tal- Marda Aujeszky li jinstab fil- beraħ.
Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Immunizzazzjoni passiva tal- frieħ tal- majjaliet vaċċinati sabiex titnaqqas il- mortalita ’ u s- sinjali kliniċi tal- Marda Aujeszky u sabiex jitnaqqas it- tixrid tal- virus tal- Marda Aujeszky li jinstab fil- beraħ.
- Active immunity:
- Immunita ’ attiva:
The onset of immunity is from 3 weeks after basic vaccination.
L- immunita ’ ssir effettiva minn 3 ġimgħat wara t- tilqima bażika.
The immunity lasts
L- immunita ’ ddum
for 3 months after basic vaccination.
għal 3 xhur wara t- tilqima bażika.
Special precautions for use in animals Do not administer in conjunction with other medicinal products.
Prekawzjonijiet speċjali għall- użu fl- annimali Tamministrax dan il- prodott flimkien ma ’ prodotti oħra mediċinali.
Each piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
Kull ħannus ta ’ majjaliet imlaqqma għandu jieħu kwantita ’ adegwata ta ’ kolostrum u ħalib.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash and disinfect hands and equipment after use.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Aħsel u ddiżinfetta l- idejn u t- tagħmir użat wara l- użu.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
F' każijiet rari jista ’ jkun il- kawża li jkollok taqta 'subgħajk jekk ma tikkonsultax tabib mill- ewwel.
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 tigi njettat bi żball b' dan il- prodott, fittex għajnuna medika mill- ewwel, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'nformazzjoni miegħek.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġiegħ idum għal aktar minn 12- il siegħa, wara l- eżami mediku, erġa 'kellem lit- tabib.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il - prodott tista 'tikkawza nefħa intensa, li tista' per ezempju tikkawza nekrożi iskimika u anke il- bżonn li jinqata 'xi subgħa.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata MAL- EWWEL u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata il- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa u t- tendin tal- muskolu.
4.6 Adverse reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravita ’)
Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50% of the pigs.
Reazzjonijiet lokali ħfief u temporanji sa 2 ċm fid- dijametru wara l- ewwel tilqima u sa 5 ċm wara t- tieni tilqima jistgħu jiġru f’ sa 50% mill- majjali ttrattati.
In general these reactions disappear within 3 weeks post primary vaccination.
Ġeneralment, dawn ir- reazzjonijiet jisparixxu fi żmien 3 ġimghat wara l- ewwel tilqima.
A transient increase in body temperature, up to about 40.5oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
F’ numru żgħir mill- majjali ttrattati tista ’ sseħħ żjieda temporanja fit - temperatura tal- ġisem sa madwar 40. 5°C li ddum sa jumejn.
In very rare cases (< 1/ 100000), hypersensitivity can be observed.
F’ każijiet rari ħafna (< 1/ 100 000), jistgħu jkunu osservati reazzjonijiet ta ’ sensittività eċċessiva.
No information is available on the compatibility of this vaccine with any other.
M' hemmx informazzjoni disponibbli dwar il- kompatibilità ta ’ dan it- tilqim ma ’ kwalunkwe tilqim ieħor.
Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Għalhekk is- sigurtà u l- effiċjenza ta ’ dan il- prodott jekk jintuża flimkien ma ’ kwalunkwe prodott iehor (użat fl- istess ġurnata jew f’ ħinijiet differenti) ma ġietx dimostrata.
4.9 Amounts to be administered and administration route
3 4. 9 Doża rakkomandata u l- metodu ta 'amministazzjoni
For intramuscular use To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Użu għal ġol- muskoli Sabiex tirrikostitwixxi it- tilqima, injetta 3ml ta ’ solvent ġol- fjala żgħira bit- trab.
Shake gently to disolve the vaccine and transfer the disolved vaccine into the vial with the solvent.
Ċaqlaq bil- mod sabiex iddewweb it- tilqima u għaddi t- tilqima mdewwba għal ġol- fjala mas- solvent.
To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Sabiex tevita li tagħmel ir- ragħwa, ċaqlaq il- fjala, li fiha komponent li ġie mnixxef u ffriżat ġol - komponent likwidu, bil- mod wara r- rikostituzzjoni.
Use sterile syringes and needles.
Uża siringi u labar steriliżżati.
Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
Tilqima bażika ta ’ majjali tar- refgħa u tar- razza (qżieqeż, majjaliet u foħla):
3 Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars): • Inject one dose per fattening pig from the age of 10 weeks.
Injetta doża waħda kull majjal tal- għalla mill- eta ’ ta ’ 10 ġimgħat.
A second dose may be injected 3 – 4 weeks after the first injection.
Doża oħra tista ’ tiġi injettata bejn 3- 4 ġimgħat wara l- ewwel injezzjoni.
The presence of maternal antibodies against Aujeszky’ s Disease Virus may have a negative influence on the result of vaccination. • Inject one dose per breeding pigs (gilts, sows and boars) from the age of 10 weeks followed by a second injection 3 – 4 weeks after the first injection.
Injetta doża waħda kull bhima miżmuma għar- razza (qżieqeż, majjaliet u foħla) mill- eta ’ ta ’ 10 ġimgħat u ssokta bit- tieni injezzjoni bejn 3- 4 ġimgħat wara l- ewwel injezzjoni.
Re-vaccination of breeding pigs (gilts, sows and boars): • Inject one dose per gilt before the first mating, or • Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of farrowing. • Inject one dose per boar at least every 6 months.
Injetta doża waħda kull faħal tal- inqas kull 6 xhur.
For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Biex tlaqqam il- merħla kollha, tista ’ tiġi amministrata doża waħda kull qażquż, majjala u faħal, kull 4 xhur.
Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Minbarra minn żjieda fir- reazzjoni tat- tessut fil- post fejn ingħatat l- injezzjoni, ma ġewx osservati effetti oħra mhux mixtieqa.
QI 09 AD 01
QI 09 AD 01 Tilqima kontra l- virus tal- marda Aujeszky.
The active substance stimulates active immunity against Aujeszky’ s Disease in pigs.
Is- sustanza attiva tistimula l- immunita ’ attiva kontra l- Marda Aujeszky fil- majjali.
By reconstitution of the immunogen in the oil emulsion, the stimulation of immunity after injection is prolonged.
Bir- rikonstituzzjoni tal- immunogen fl- emulsjoni taż- żejt, l- istimulazzjoni tal- immunita ’ wara l- injezzjoni, tiġi mtawwla.
Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
Il - friegħ ta ’ dawk il- qżieqeż u majjaliet li jkunu mlaqqma, jiksbu immunita ’ passiva mill- kolostrum u l - ħalib.
The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky’ s Disease Virus, if the vaccine is used in association with an appropriate diagnostic test.
Il- karatteristika tal- gE - (glycoprotein E negative) tal- virus tat- tilqim tagħmilha possibbli sabiex issir distinzjoni bejn l- anti- korpi li ġew indotti permezz tat- tilqima b’ dan il- prodott u dawk li ġew indotti permezz ta ’ infezzjoni li tittieħed fil- beraħ mill- Virus tal- Marda Aujeszky, jekk it- tilqima tiġi mogħtija wara li jkun sar eżami dijanjostiku tajjeb.
Therefore, the product is suitable to be used in eradication programmes against Aujeszky’ s Disease field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
Għaldaqstant, il- prodott huwa adatt biex jintuża fi programmi maħsuba biex jeqirdu l- virus li jinstab fil- beraħ tal- Marda Aujeszky fil- majjali ibbażat fuq il- presenza jew l- assenza ta ’ anti- korpi kontra l- gE- antigen ta ’ dak il- virus.
Aluminium hydroxide Mineral oil (Marcol 52)l Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol Water for injections
Aluminium hydroxide Żejt minerali( Marcol 52) l Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol Ilma għall- injezzjoni
4 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
2 years.
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (trab):
Shelf-life of the veterinary medicinal product as packaged for sale (solvent):
Sentejn Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (solvent):
Shelf-life after reconstitution according to directions:
Sentejn Żmien li l- prodott jibqa 'tajjeb wara li jitħallat skond l- istruzzjonijiet:
1 hour
Siegħa.
Powder for emulsion for injection:
Trab għal emulsjoni għal injezzjoni:
7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder.
Fjali ta ’ 7 ml tal- ħġieġ idrolitiku tat- Tip I li fihom 10, 50 jew 100 doża ta ’ trab li ġie mnixxef u ffriżat.
The vials are closed with a butyl rubber stopper and sealed with an aluminium cap.
Il - fjali huma magħluqa b’ tapp tal- gomma butyl u ssiġġillati b’ għatu tal- aluminjum.
Solvent for emulsion for injection:
Solvent għal emulsjoni għal injezzjoni:
20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50- doses or 100-doses presentation.
Fliexken ta ’ 20 ml, 100 ml jew 200 ml tal- ħġieġ idrolitiku tat- Tip I li fihom solvent għal formulazzjonijiet tal- 10 dożi, tal- 50 doża jew tal- 100 doża.
The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Kaxxa tal- kartun bi fjala tat- trab u flixkun ta ’ solvent jew 10 fjali ta ’ trab u 10 fliexken ta ’ solvent għal injezzjoni.
Not all pack sizes may be marketed.
Mhux id- daqs tal- pakketti kollha jistgħu jitpoġġew fis- suq.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any.
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill - Awtorità Kompetenti tal- pajjiż.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp L- Olanda
22.08.2008
DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
Prohibition of sale, supply and/ or use
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
The import, sale, supply and/ or use of Suvaxyn Aujeszky 783 + OW is or may be prohibited in certain Member States on the whole or part of their territory pursuant to National animal health policy.
L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'Suvaxyn Aujeszky 783 + OW huwa pprojbit jew jista ’ jkun ipprojbit f' ċertu Stati Membri jew ġo parti mit- territorju tagħhom minħabba l- politika Nazzjonali tagħhom dwar is- saħħa tal- annimali.
Any person intending to import, sell, supply and/ or use Suvaxyn Aujeszky 783 + OW must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża Suvaxyn Aujeszky 783 + OW għandha tikkonsulta mal- Awtorita ’ Kompetenti tal- Pajjiż Membru dwar il- programmi ta 'tilqim kurrenti qabel timporta, tbiegħ, tissupplixxi u / jew tuża.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U S- SID( SIDIEN) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID( S- SIDIEN) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
Name and address of the manufacturers of the biological active substances Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i) Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp L- Olanda Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott.
Name and address of the manufacturer(s) responsible for batch release Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp L- Olanda
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skond l- Artikolu 71 tad- Direttiva 2001/ 82/ EC tal- Parlament Ewropew u tal- Kunsill kif amendat, l- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu tal - prodott mediċinali veterinarju fit- territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għotja tal- prodott mediċinali veterinarju lill- annimali tinterferixxi ma ’ l- implimentazzjoni ta ’ programmi nazzjonali għad- djanjosi, il- kontroll u l- eradikazzjoni tal- mard ta ’ l- annimali, jew tikkawża diffikultajiet fiċ- ċertifikazzjoni ta ’ l- assenza tal- kontaminazzjoni f ’ annimali ħajjin jew fl - ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
Annex II of Council Regulation (EEC) No 2377/ 90 Pharmacologically active substance Aluminium hydroxide Disodiumhydrogenphosphate Mannitol Mineral oil Polysorbate 80 Sodiumhydrogenphosphate Thiomersal
Anness II tar- Regolament tal- Kunsill (EEC) Nru 2377/ 90 Sustanza farmakoloġikament attiva
Animal Species All food-producing species
Speċje ta ’ l- annimal
LABELLING AND PACKAGE INSERT
OBBLIGAZZJONIJIET SPEĊIFIĊI TA 'SID L- AWTORIZZAZZJONI TAL- KUMMERĊ
LABELLING
9 ANNESS III
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT
(Carton label 1 x 10 doses)
TIKKETTA
Suvaxyn Aujeszky 783 + O/ W, powder and solvent for emulsion for injection
Għall- majjali
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Virus inattivat tal- Marda Aujeszky, tal- grupp NIA 3- 783: ≥ 10 5. 2 CCID 50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID50= il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulat.
Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal
Aluminium hydroxide, Żejt Minerali (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal
Powder and solvent for emulsion for injection
Trab u solvent għall- emulsjoni għall- injezzjoni
1 vial with powder for injection (10 doses) and 1 bottle of solvent for injection (20 ml)
Fjala waħda bi trab għall- injezzjoni (10 dożi) u flixkun wieħed ta ’ solvent għall- injezzjoni (20 ml)
Active and passive immunisation of pigs against Aujeszky’ s Disease.
Immunizzazzjoni attiva u passiva tal- majjali kontra l- Marda Aujeszky.
For intramuscular use of 1 dose (2 ml) per pig
Użu għal ġol- muskoli ta ’ doża waħda (2ml) għal kull majjal
Accidental injection is dangerous - see package insert before use for further information and additional warnings.
Jekk tinjetta bi żball huwa perikoluż – aqra ’ l- fuljett ta 'tagħrif fil- pakkett qabel tuża għal aktar tagħrif u twissijiet addizzjonali.
EXP {month/ year} Shelf life after reconstitution:
Jiskadi {xahar / sena} Wara r- rikostituzzjoni:
Use within one hour
Uża fi żmien siegħa
Store (and transport) at 2ºC - 8ºC (in a refrigerator).
Aħżen (u ttrasporta) f' temperatura ta '2°C – 8°C (fil- friġġ).
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR, JEKK IKUN IL- KAŻ
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill - Awtorita ’ Kompetenti tal- pajjiż.
For animal treatment only Veterinary medicinal product subject to prescription.
Prodott mediċinali veterinarju sabiex jiġi mogħti bi preskrizzjoni.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package leaflet for further information.
l- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu ta ’ dan il- prodott mediċinali veterinarju huwa jew jista ’ jiġi pprojbit f’ ċerti Stati Membri, fit- territorju sħiħ tagħhom jew parti minnu, ara l- fuljett ta 'tagħrif fil - pakkett għall- aktar tagħrif.
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
{number} for the powder:
{numru} għat- trab:
{number} for the solvent:
{numru} għas- solvent:
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
(Carton label 1 x 50 doses)
Tikketta tal- Kartuna 1 x 50 doża
Powder::
Trab:
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Virus inattivat tal- Marda Aujeszky, tal- grupp NIA 3- 783: ≥ 10 5. 2 CCID 50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID50 = il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulat.
1 vial with powder for injection (50 doses) and 1 bottle of solvent for injection (100 ml)
Fjala waħda bi trab għall- injezzjoni (50 doża) u flixkun wieħed ta ’ solvent għall- injezzjoni (100 ml)
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat u approvat mill - Awtorita ’ Kompetenti tal- pajjiż.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ AWTORIZZAZZJONI TAL- KUMMERĊ
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
(Carton label 1 x 100 doses)
Tikketta tal- Kartuna 1 x 100 doża
1 vial with powder for injection (100 doses) and 1 bottle of solvent for injection (200 ml)
Fjala waħda bi trab għall- injezzjoni (100 doża) u flixkun wieħed ta ’ solvent għall- injezzjoni (200 ml)
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
(Carton label 10 x 10 doses)
Tikketta tal- Kartuna 10 x 10 dożi
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Virus inattivat tal- Marda Aujeszky, tal- grupp NIA 3- 783: ≥ 10 5. 2 CCID 50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID50 = = il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulat.
10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection (each containing 20 ml)
10 fjali bi trab għall- injezzjoni (kull fjala fiha 10 dożi) u 10 fliexken ta ’ solvent għall- injezzjoni (kull flixkun fih 20 ml)
Active and passive immunisation of pigs against Aujeszky’ s Disease.
L- immunizzazzjoni attiva u passiva tal- majjali kontra l- Marda Aujeszky.
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal żghar.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
23 TAGĦIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
(Carton label 10 x 50 doses)
Tikketta tal- Kartuna 10 x 50 doża
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Virus inattivat tal- Marda Aujeszky, tal- grupp NIA 3- 783: ≥ 10 5. 2 CCID 50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID50= il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulati.
10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection (each containing 100 ml)
10 fjali bi trab għall- injezzjoni (kull fjala fiha 50 doża) u 10 fliexken ta ’ solvent għall- injezzjoni (kull flixkun fih 100 ml)
For intramuscular use of 1 dose (2 ml) per pig
Użu għal ġol- muskoli ta ’ doża waħda ta ’ (2ml) għal kull majjal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat u approvat mill - Awtorita ’ Kompetenti tal- pajjiż..
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
(Carton label 10 x 100 doses)
Tikketta tal- Kartuna 10 x 100 doża
10 vials with powder for injection (each containing 10 doses) and 10 bottles of solvent for injection (each containing 200 ml)
10 fjali bi trab għall- injezzjoni (kull fjala konenenti 10 dożi) u 10 fliexken ta ’ solvent ghall- injezzjoni (kull flixkun kontenenti 200 ml)
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR IMMEDJAT
(10 doses)
(10 dożi)
Vials for the powder:
Fjali tat- trab:
Suvaxyn Aujeszky 783 + O/ W, powder for injection.
Suvaxyn Aujeszky 783 + O/ W, trab għall- injezzjoni.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITA TAS- SUSTANZA( I) ATTIVA( I)
Live attenuated Aujeszky’ s Disease Virus
Virus ħaj inattivat tal- Marda Aujeszky
10 doses
10 dożi
For intramuscular use
Użu għal ġol- muskoli
Bottles for the solvent:
Fliexken għas- solvent:
Suvaxyn Aujeszky 783 + O/ W, solvent for injection.
Suvaxyn Aujeszky 783 + O/ W, solvent għall- injezzjoni.
QUANTITY
KWANTITA
20 ml (10 doses)
20 ml (10 dożi)
EXP {month/ year} Use within one hour after reconstitution
Jiskadi {xahar/ sena} Uża fi żmien siegħa wara r- rikostituzzjoni
Accidental injection is dangerous – see package insert before use
Jekk tinjetta bi żball huwa perikoluż – aqra ’ l- fuljett ta 'tagħrif qabel tuża
30 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR IMMEDJAT
(50 doses)
(50 doża)
Suvaxyn Aujeszky 783 + O/ W, powder for injection
Suvaxyn Aujeszky 783 + O/ W, trab għall- injezzjoni.
Suvaxyn Aujeszky 783 + O/ W, solvent for injection
Suvaxyn Aujeszky 783 + O/ W, solvent għall- injezzjoni.
100 ml (50 doses)
100 ml (50 doża)
32 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR IMMEDJAT
(100 doses)
(100 doża)
100 doses
100 doża
200 ml (100 doses)
200 ml (100 doża)
PACKAGE LEAFLET
FULJETT TA 'TAGHRIF
35 1.
Għall- majjali
Manufacturer for the batch release:
Manifattur responsabbli li jħalli l- konsenja tmur fis- suq:
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Virus ħaj inattivat tal- Marda Aujeszky, razza NIA 3- 783: ≥ 10 5. 2 TCID50 * għal kull doża ta ’ 2 ml ta ’ emulsjoni rikostitwita. * TCID 50 = il- kwantita ta ’ virus, li jinfetta 50% tal- kolturi ta ’ ċelluli tat- tessut inokulat.
One dose of 2 ml contains:
Kull doża ta ’ 2ml fiha:
Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
L- immunizzazzjoni attiva tal- majjali mill- eta ’ ta ’ 10 ġimgħat sabiex tiġi evitata l- mortalita ’ u s- sinjali kliniċi tal- Marda Aujeszky u sabiex jitnaqqas it- tixrid tal- virus tal- Marda Aujeszky li jinstab fil- beraħ.
Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky’ s Disease and to reduce the excretion of Aujeszky’ s Disease field virus.
Immunizzazzjoni passiva tal- frieħ tal- qżieqeż u majjaliet vaċċinati sabiex titnaqqas il- mortalita ’ u s- sinjali kliniċi tal- Marda Aujeszky u sabiex jitnaqqas it- tixrid tal- virus tal- Marda Aujeszky li jinstab fil- beraħ.
The onset of immunity is from 3 weeks after basic vaccination.
L- immunita ’ issir effettiva minn 3 ġimgħat wara t- tilqima bażika.
CONTRAINDICATIONS
37 5 KONTRA- INDIKAZZJONIJIET
In general these reactions disappear within 3 weeks after the first vaccination.
Ġeneralment, dawn ir- reazzjonijiet jisparixxu fi żmien 3 ġimghat wara l- ewwel tilqima.
A transient increase in body temperature, up to about 40,5oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
F’ numru żgħir mill- majjali ttrattati tista ’ sseħħ żjieda temporanja fit - temperatura tal- ġisem sa madwar 40. 5°C li ddum sa jumejn.
For intramuscular use
Użu għal ġol- muskoli.
Vaccination programme:
Programm ta ’ tilqim:
Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
Tilqima bażika ta ’ majjali tar- refgħa u dawk miżmuma għar- razza (qżieqeż, majjaliet u foħla):
• Inject one dose per fattening pig from the age of 10 weeks.
Injetta doża waħda kull ħanzir tal- għalla mill- eta ’ ta ’ 10 ġimgħat.
The presence of maternal antibodies against Aujeszky’ s Disease Virus may have a negative influence on the result of vaccination. • Inject one dose per breeding pig (gilts, sows and boars) from the age of 10 weeks followed by a second injection 3 – 4 weeks after the first injection.
Injetta doża waħda kull bhima miżmuma għar- razza (qżieqeż, majjaliet u foħla) mill- eta ’ ta ’ 10 ġimgħat u ssokta bit- tieni injezzjoni bejn 3- 4 ġimgħat wara l- ewwel injezzjoni.
Re-vaccination of breeding pigs (gilts, sows and boars):
Ri- vaċċinazzjoni tal- bhejjem miżmuma għar- razza (qżieqeż, majjaliet u foħla):
• Inject one dose per gilt before the first mating, or • Inject one dose per gilt or sow during each gestation at 3 - 6 weeks before the expected date of farrowing. • Inject one dose per boar at least every 6 months.
Injetta doża waħda kull faħal tal- inqas kull 6 xhur.
For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Għat- tilqim tal- merħla kollha, tista ’ tiġi amministrata doża waħda kull qażquż, majjala u faħal, kull 4 xhur.
To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Sabiex tirrikostitwixxi it- tilqima, injetta 3ml ta ’ solvent ġol- fjala żgħira bit- trab.
Shake gently to disolve the vaccine and transfer the disolved vaccine into the vial with the solvent.
Ħarrek bil- mod sabiex iddewweb it- tilqima u għaddi t- tilqima mdewwba għal ġol- fjala mas- solvent.
To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Sabiex tevita li tagħmel ir- ragħwa, ħarrek bil- mod il- fjala li fiha l- komponent mnixxef u ffriżat rikostitwit ġol- komponent likwidu.
Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
Amministra l- prodott billi tinjetta doża waħda (2ml) ġol- muskoli kull majjal fl- għonq fil- wesgħa ta ’ wara l- widna.
Each piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
Kull ħannus ta ’ majjaliet ivvaċċinati għandu jieħu ammont adegwat ta ’ kolostrum u ħalib.
Store and transport refrigerated (2°C – 8°C).
Aħżen u ttrasporta fil- friġġ 2°C – 8°C Tiffriżax.
Do not use after the expiry date stated on the label.
Tużax wara d- data tal- iskadenza indikata fuq it- tikketta.
1 hour.
Iż- żmien ta 'kemm il- prodott idum tajjeb wara li jigi mħallat skond kif rakkomandat: siegħa
Any person intending to import, sell, supply and/ or use Suvaxyn Aujeszky 783 + OW has to consult the relevant Member States competent Authorities on the current vaccination policies prior to the import, sale, supply and/ or use.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża Suvaxyn Aujeszky 783 + OW għandu jikkonsulta mal- awtorita ’ kompetenti tal- Pajjiż Membru dwar il- programmi ta 'tilqim kurrenti qabel jimporta, jbiegħ, jissupplixxi u / jew juża.
Wash and disinfect hands and equipment after use.
Aħsel u ddiżinfetta l- idejn u t- tagħmir wara l- użu.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġiegħ kbir u nefħa speċjalment jekk tinjetta f' ġog jew subgħa u f' każijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mill- ewwel.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġiegħ idum għal aktar minn 12- il siegħa, wara l- eżami mediku, erġa 'kellem tabib darb’ oħra.
To the physician:
39 Għat- Tabib:
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
TAGĦRIF DWAR RIMI TA 'PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR - RIMI, JEKK IKUN IL- KAŻ
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi il- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant adattat approvat mill - awtoritajiet kompetenti tal- pajjiż.
By reconstitution of the immunogen in the oil emulsion the stimulation of immunity after injection is prolonged.
Bir- rikostituzzjoni tal - immunogen fl- emulsjoni taż- żejt, l- istimulazzjoni tal- immunita ’ wara l- injezzjoni, tiġi mtawwla.
Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
Il- frieħ tal- majjaliet imlaqqma, jiksbu immunita ’ passiva mill- kolostrum u l- ħalib.