qanastek/EMEA-V3 huggingface dataset:
Before using the vaccine allow it to reach room temperature (15-25°C) and shake well before use.
Qabel tużgħa t- tilqima, ħalliha tilħaq it- temperatura tal- kamra (15- 250C) u ħawwad sew qabel l- użu.
Do not freeze.
PERJODU TA 'TIŻMIM
Protect from light.
Tiffriżax.
8 hours
8 sigħat.
Vaccinate only healthy animals
Laqqam biss annimali b`saħħithom
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa specjalment jekk tinjetta f' ġog jew subgħa u f' kazijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel.
18/ 19 To the physician:
18/ 19 Jekk tiġi njettat bi żball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'informazzjoni li tinsab fil- pakkett miegħek.
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 l- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa jew it- tendin tal- muskolu
Do not use during pregnancy and lactation.
L- użu tiegħu m' huwiex rakkomandat waqt it- tqala jew fi żmien il- ħalib.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Għalhekk, id- deċiżjoni li dan il - vaċċin jintuża qabel jew wara kwalunkwe prodott mediċinali veterinarju għandha tittieħed każ b’ aż.
Do not mix with any other veterinary medicinal product.
Tħallatx ma kwalunkwe prodott medicinali veterinarju ieħor.
Following the administration of a double dose of vaccine no side effects other than those described under “ adverse reactions” have been observed.
Wara l- amministrazzjoni ta ’ doża doppja tal- vaċċin l- ebda effett mhux mixtieq, apparti dawk imsemija taħt “ effetti mhux mixtieqa ” ma ġie osservat.
1 or 10 vials of 20, 50, 100, 200, 500 ml (10/ 25/ 50/ 100/ 250 doses).
1 jew 10 PET fjali ta ’ 20, 50, 100, 200, 500 ml. (10/ 25/ 50/ 100/ 250 dożi).
ed e nd sp
d de n pe us nS tio isa ANNESS I
SUMMARY OF PRODUCT CHARACTERISTICS isa or uth gA tin ker Ma
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR or uth gA tin ker Ma
1/ 17 1.
1/ 21 1.
Porcilis Pesti emulsion for injection
Porċilis Pesti emulsjoni għal injezzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
d de GĦAMLA KWALITATTIVA U KWANTITATTIVA 2.
120 Elisa Units (EU) per dose of 2 ml
n Classical Swine Fever Virus (CSFV) - E2 subunit antigen: 120 Elisa units (EU) għal kull doża ta ’ 2
nd Adjuvant:
pe millilitri
941.4 mg liquid paraffin per dose of 2 ml
Sustanzi mhux attivi:
e For a full list of excipients, see section 6.1
941. 4 mg / 2ml
Su Emulsion for injection.
Emulsjoni għal injezzjoni
4.
tio 4.
CLINICAL PARTICULARS
KWALITAJIET IMMUNOLOGIĊI
n 4.1 Target species tio Pigs. isa
TAGĦRIF KLINIKU uth
4.2 Indications for use, specifying the target species
5. 1 Speċi li l- prodott għandu jintuża fuqhom
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus. or
Majjali
The duration of protection is 6 months. uth
5. 2 Indikazzjoni għal użu tal- Prodott (semmi l- ispeċi li għandu jintuża fuqhom il- prodott) jekk gA
4.3 Contraindications
ikun il- każ.
None gA
Immunita attiva lil majjali minn ames imgħat il- fuq biex tevita l- imwiet u tnaqqas sinjali kliniċi ta ’
4.4 Special warnings for each target species
ħ
None tin
ġ
4.5 Special precautions for use
Classical Swine Fever, kif ukoll biex tnaqqas infezzjoni u tneħħija tal- virus CSF fil- beraħ. tin
Special precautions for use in animals ke
5. 3 Kontra indikazzjonijiet
Not applicable
Xejn ke
Special precautions to be taken by the person administering the veterinary medicinal product to r
5. 4 Effetti mhux mixtieqa (frekwenza u gravita) r
animals Ma
Nefħa li afna Ma
To the user:
ġ ġ
This product contains mineral oil.
ħ
If pain persists for more than 12 hours after medical examination, seek medical advice again.
drabi tinżel waħedha tista ’ tinħoloq fis- sit tal- injezzjoni sa erba ’ imgħat wara l- injezzjoni. ieda fit -
To the physician:
ġ
This product contains mineral oil.
Ż
ed this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Tiġmiegħ ta ’ materja taħt il- ġilda jista ’ jseħħ fis- sit tal- injezzjoni.
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.
Minħabba li għadu qatt ma gie eżaminat it- tħaris tas- saħħa tal- annimal jekk wieħed jinokula fl- istess sit, huwa rakkomandat li t- tieni darba tlaqqam f’ post differenti.
nd 4.6 Adverse reactions (frequency and seriousness)
2/ 21 5. 5 Prekawzjonijiet Speċjali għall- Użu
A local and in most cases transient swelling at the injection site may occur up to 4 weeks after
Qabel ma tuża l - vaċċin alliha tilħaq it- temperatura tal- kamra (15o – 25o). awwad sewwa qabel
e administration of each dose of the vaccine.
Dejjem uża siringi u labar sterili.
Transient hyperthermia may occur post the second dose.
Evita li tikkontamina.
Abscesses may be observed at the injection site.
Laqqam biss animali f’ saħħithom.
Since safety after giving both inoculations at the same
Huwa rakkomandat li tuża sistema magħluqa li tieħu aktar minn tilqima waħda.
sp site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
de 5. 6 Użu fit- Tqala u fi mien il- ħalib ż Jista ’ jintuża waqt it- tqala pero mhux evitat li l- virus tas- CSF jgħaddi mill- omm għall- feti.
Su 4.7 Use during pregnancy, lactation or lay
n pe 5. 7 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
M' hemmx informazzjoni dwar l- effett u l- effiċjenza ta ’ din it- tilqima jekk tintuża flimkien ma kwalunkwe tilqim ieħor. Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra meta qed
It is therefore recommended that no other vaccines can be administered concurrently with the product. isa
us jintuża dan il- prodott
4.9 Amounts to be administered and administration route
5. 8 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Shake well before use. or
Ħ
Intramuscular injection of one dose (2 ml) in the neck in the area behind the ear.
Injezzjoni intramuskulari ta ’ 2 ml tal- vaċċin, fl - għonq wara l- widna.
Vaccination scheme: uth
5. 10 Twissijiet speċjali għal kull speċi li għaliha hu indikat il- prodott. uth
Basic vaccination: injection.
5. 11 Perjodu ta 'Tiżmim
Inject one dose per pig followed by a second injection 4 weeks after the first
5. 12 Prekawzjonijiet speċjali li għandhom jittiehdu mill- persuna li tamministra l- prodott mediċinali lill- annimali
Re-vaccination:
Ghal min se juża: tin
Every 6 months, using a single dose.
Dan il- prodott fih ejt minerali.
Use sterile syringes and needles.
Injezzjoni accidentali jew jekk tinjetta lilek innifsek jista 'jirrizulta ż f' uġigħ kbir u nefħa speċjalment jekk tinjetta f' ġog jew subgħa u f' kazijiet rari jista ’ jkun il - kawza li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel. ke
Avoid the introduction of contamination. gA
Jekk tiġi njettat bi ball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont g ir afna gie
Vaccinate healthy animals only.
njettat u u l- fuljett ta 'nformazzjoni miegħek.
It is recommended to use a closed multiject vaccination system.
Jekk l- ugigħ idum ghal aktar minn tnax il- siegħa, wara l - ħ r
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary tin
Ma
After administration of an overdose, local reactions at the injection site may be more pronounced.
Anke jekk ew injettati ammonti g ar, injezzjoni bi ball ta ’ dan il -
4.11 Withdrawal period(s) ke
ġ
Zero days r Ma
ħż
5.
ż
QI09AD04 The active substance stimulates active immunity against Classical Swine Fever (CSF).
prodott tista 'tikkawża nefħa intensa, li tista' per ezempju tikkawża nekrożi iskimika u anke il- bżonn li jinqata 'xi subgħa.
As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigens, other than E2.
Attenzjoni minn kirurgu espert ghandha tingħata mal- ewwel u jista ’ jkun hemm
PHARMACEUTICAL PARTICULARS
3/ 21 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. >
6.1 List of excipients
d de n pe us nS tio isa or uth gA tin ke r Ma
ed Polysorbate 80 Sorbitan oleate
TAGĦRIF FARMAĊEWTIKU
6.2 Incompatibilities
6. 1 Inkompatibilitajiet Maġġuri
nd Do not mix with any other vaccine or immunological product.
d Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
e 6.3 Shelf life
de 6. 2 mien ta 'kemm il- prodott idum tajjeb Ż mien li l- prodott jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
sp 3 years.
3 snin
Shelf life after first broaching the bottle:
n Ż Perjodu ta ’ a na wara li jinfetaħ il- flixkun:
3 hours.
3 siegħat żħ
Su 6.4 Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħażen
Store in a refrigerator (2°C to 8°C).
Aħżen f' temperatura ta '2°Ċ – 8°Ċ.
6.5 Nature and composition of immediate packaging
us 6. 4 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm go fih
n tio Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses, 100 ml for 50 doses and 250 ml for 125 doses presentation.
nS Fliexken magħmula minn ieġ (idrolitiku tip 1) jew polyethylene terephthalate (PET) tal - 50 millilitru ġħ għal 25 doża, 100 ml għal 50 doża u 250 ml għal 125 doża.
The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminum cap.
Il- fliexken huma magħluqa b’ tapp tal- lastiku tat - tip nitryl rubber u kappa tal- aluminjum bil- kodiċi fuqha.
The bottles are packed individually in a carton box. isa
Il- fliexken huma ppakkjati individwalment f’ kaxxa tal- kartun.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. uth
tio 6. 5 Tagħrif għall- użu u maniġġjar u għar- rimi tal- mediċina mhux użata jew materjal ieħor jekk ikun il- każ isa Mediċina veterinarja li ma gietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż. or
MARKETING AUTHORISATION HOLDER
ISEM JEW L- ISEM KORPORATTIV U L- INDIRIZZ JEW L- INDIRIZZ TAL- POST TAL- KUMMERĊ IRREĠISTRAT, TAS- SID TAL- AWTORIZZAZZJONI TAL - KUMMERĊ. uth
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands tin
Intervet International B. V Wim de Korverstraat 35 5831 AN Boxmeer L- Olanda gA
MARKETING AUTHORISATION NUMBER(S)
Projbizzjoni ta 'Bejgħ, Provvista u / jew Użu L- importazzjoni, bejgħ, provvista u / jew l- użu ta' dan il- prodott mediċinali veterinarju huwa permess f’ kundizzjonijiet partikulari stabbiliti legalment mill- Komunita Ewropeja dwar kontrol tal - CSF tin
EU/ 2/ 99/ 016/ 001-006 ke
80/ 217/ EEC kif ammendata).
DATE OF THE FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION r Ma
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel provvista jew tuża dan il- prodott għandu jkun awtorizzat mill- Awtorita Kompetenti tal- Pajjiż Membru. ke r Ma
4/ 17 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
5/ 21 Numru tar - Reġistru tal- Komunita tal- prodotti mediċinali
PROHIBITION OF SALE, SUPPLY AND/ OR USE
d EU/ 2/ 99/ 016/ 001 – 6
nd must be authorised by the competent authority of the Member State.
de Data tal- ewwel Awtorizzazzjoni / Tiġdid tal- Awtorizzazzjoni
e sp Ma
09/ 06/ 2000
r ke
n Data ta 'meta iet riveduta din il- kitba ġ
uth
pe us nS tio isa or uth gA tin ke r Ma
5/ 17 ed
6/ 21 d de n pe us nS ANNESS II
ANNEX II
tio A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR isa
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT isa B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE or
KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ INKLUŻI RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU or
C.
.
CONDITIONS OR RESTRICTIONS OF THE MARKETING uth
PROJBIZZJONI TAL- BEJGĦ, TAL- FORNIMENT U/ JEW Ċ TA ’ L- UŻU uth
STATEMENT OF THE MRLs gA tin ker Ma
DIKJARAZZJONI TA ’ L- MRLs gA tin ker Ma
6/ 17 A.
7/ 21 A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Manufacturer of the biological active substance:
d Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott.
ed Nobilon International BV Exportstraat 39b 5830 AH Boxmeer
de Intervet International B. V Wim de Korverstraat 35 5831 AN Boxmeer
nd The Netherlands
n L- Olanda
or
pe B.
sp Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ
Su Manufacturer responsible for batch release
INKLUŻI
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION isa
us RESTRIZZJONIJIET DWAR IL- FORNIMENT U L- UŻU
To be supplied only on veterinary prescription. or
Prodott mediċinali veterinarju jingħata bir- riċetta tat- tabib
According to Community Legislation on Classical swine fever (Council Directive 80/ 217/ EEC, as amended), in the European Union: uth
nS According to Community Legislation on Classical swine fever (Council Directive 80/ 217/ EEC, as amended), in the European Union:
a) The use of classical swine fever vaccines is prohibited.
a) The use of classical swine fever vaccines is prohibited.
However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordane with Community Legislation on control and eradication of classical swine fever; gA
However, the use of vaccines may be
b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State; tin
tio authorized in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordane with Community Legislation on control and eradication of classical swine fever; isa b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State; or
c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pigmeat from vaccinated pigs. r ke Ma
c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pigmeat from vaccinated pigs. uth
7/ 17 C.
8/ 21 D.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
DIKJARAZZJONI TA ’ L- MRLs
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/ or use of Porcilis Pesti on the
d Il- Kumitat għall- Prodotti Mediċinali Veterinarji rrakkomanda l- inklużjoni ta ’ ejt minerali fl- Anness II ż tar- Regolament tal- Kunsill (KEE) Nru 2377/ 90 skond it- tabella li ejja: ġ
ed whole or part of their territory if it is established that:
de
nd difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
Sustanza( i) farmakoloġikament attiva( i)
e b) the disease to which the product is intended to confer immunity is largely absent from the territory.
Speċje ta ’ l- annimal
STATEMENT OF THE MRLs
Dispożizzjonijiet oħrajn
Su Annex II of Council Regulation (EEC) No 2377/ 90 Pharmacologically active substance Liquid paraffin (Mineral hydrocarbons)1 Polysorbate 80 2 Sorbitan mono-oleate 3 (E494)
Liquid paraffin (Mineral
Animal Species All food-producing species n tio
producing species
Other provisions
pe Polysorbate 80 2 Sorbitan mono- oleate 3 (E494)
isa or uth gA tin r ke Ma
us nS tio isa or uth gA tin ke r Ma
8/ 17 ed
9/ 21 d de n pe us nS tio isa ANNESS III
LABELLING AND PACKAGE LEAFLET isa or uth gA tin ker Ma
TIKKETTA U L- FULJETT INFORMATTIV or uth gA tin ker Ma
9/ 17 Ma rke tin gA
10/ 21 Ma rke tin gA
10/ 17 isa LABELLING tio
11/ 21 isa TIKKETTA tio nS us pe
{50ml Bottle/ 100ml Bottle/ 250ml Bottle}
d {50ml/ 100ml/ 250ml}
ed 1.
de 1.
nd Porcilis Pesti
n Porċilis Pesti emulsjoni għal injezzjoni
e sp Per dose of 2 ml:
GĦAMLA KWALITATTIVA U KWANTITATTIVA
120 Elisa Units CSF-E2 antigen.
120 Elisa units Classical Swine Fever Virus (CSFV) - E2 subunit antigen
Liquid paraffin:
nS Paraffina likwida:
941.4 mg
941. 4 mg / 2ml
Emulsion for injection
DAQS TAL- PAKKETT
PACKAGE SIZE n tio 50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses) isa
50 ml (25 doża ta ’ 2ml) / 100 ml (50 doża ta ’ 2ml) / 250 ml (125 doża ta ’ 2ml) or
TARGET SPECIES
SPEĊI GĦAL X' HIEX HUWA NDIKAT IL- PRODOTT uth
Pigs or uth
Majjali
INDICATION(S)
INDIKAZZJONI / JIET gA
Vaccine against Classical Swine Fever gA
Classical Swine Fever, kif ukoll biex tnaqqas infezzjoni u tneħħija tal- virus CSF fil- beraħ. tin
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI ke
IM injection of 2 ml tin
Ħ Injezzjoni intramuskulari ta ’ 2 ml tal- vaċċin, fl - għonq wara l- widna.
Withdrawal period -Zero days r
Ċ
9.
Ċ
SPECIAL WARNING(S), IF NECESSARY Ma
Dejjem uża siringi u labar sterili.
Accidental self-injection is dangerous
Huwa rakkomandat li tuża sistema magħluqa li tieħu aktar minn tilqima waħda.
11/ 17 10.
12/ 21 8.
< EXP {month/year} > Once broached, use within 3 hours.
3 siegħat isa żħ
ed 11.
12.
SPECIAL STORAGE CONDITIONS
TAGĦRIF DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL or
Do not freeze.
A IN IEĦOR, JEKK IKUN IL- KAŻ ŻĦ Mediċina veterinarja li ma gietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew uth
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
skond kif titlob il- liġi tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ” gA
For animal treatment only. n To be supplied only on veterinary prescription. tio 14.
Għat- Trattament tal- annimali biss.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN ” isa
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ” tin
Keep out of the reach and sight of children. or
Ż ke
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER uth
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL - AWTORIZZAZZJONI TAL- MANIFATTURA r
Intervet International B. V., NL – 5831 AN Boxmeer gA
Intervet International Wim de Korverstraat 35 5831 AN Boxmeer L - Olanda
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- AWTORIZAZZJONI GĦALL- KUMMERĊ FIR- REĠISTRU TAL - KOMUNITA
EU/ 2/ 99/ 016/ 001 - EU/ 2/ 99/ 016/ 006 tin
d EU/ 2/ 99/ 016/ 001 – 6
17.
de 17.
< Batch > < Lot > < BN > {number} r ke Ma
n < Lott > {numru}
12/ 17 MINIMUM PARTICULARS TO APPEAR ON Bottle Label
14/ 21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI G AR ĦŻ
{50ml/ 100ml/ 250ml}
d {50ml/ 100ml/ 250ml}
Porcilis Pesti
n Porċilis Pesti emulsjoni għal injezzjoni
nd 2.
pe 2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA
e 120 Elisa Units CSF E2 antigen/ 2ml.
941. 4 mg / 2ml
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Emulsjoni għal injezzjoni
Su 50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses)
DAQS TAL- PAKKETT isa 50 ml (25 doża ta ’ 2ml) / 100 ml (50 doża ta ’ 2ml) / 250 ml (125 doża ta ’ 2ml)
n 4.
ġ
ROUTE(S) OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI
tio
Ċ
IM injection isa
Evita li tikkontamina.
WITHDRAWAL PERIOD
MIEN TA 'TIŻMIM Ż Xejn
Withdrawal period:
d nformazzjoni li jkun fih ewwa. ġ
Zero days or
pe informattiv.
BATCH NUMBER uth
DATA TA 'SKADENZA
< Batch > < Lot > < BN > {number}
us < Jiskadi {xahar / sena} >
7.
nS 11.
EXPIRY DATE gA
Tiffriżax.
< EXP {month/year} > Once broached, use within 3 hours. tin
3 siegħat żħ
THE WORDS “ FOR ANIMAL TREATMENT ONLY” ke
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ”
For animal treatment only. r Ma
Intervet International r
13/ 17 Ma rke tin gA uth or
17/ 21 Ma rke tin
PACKAGE LEAFLET tio
18/ 21 isa tio FULJETT TA 'TAGĦRIF nS us pe
end
1.
ed
d de 2.
PACKAGE LEAFLET
941. 4 mg / 2ml
1.
n pe 3.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JHALLI L- KONSENJA TMUR FIS- SUQ, JEKK HUWA
ed Intervet International B. V.
Intervet International
Wim de Körverstraat 35 5831 AN Boxmeer
nS Wim de Korverstraat 35 5831 AN Boxmeer L - Olanda
nd The Netherlands
tio SPEĊI GĦAL X' HIEX HUWA NDIKAT IL- PRODOTT 4.
e 2.
Majjali isa 5.
NAME OF THE VETERINARY MEDICINAL PRODUCT
INDIKAZZJONI / JIET or
sp Porcilis Pesti emulsion for injection
Immunita attiva lil majjali minn ames imgħat il- fuq biex tevita l- imwiet u tnaqqas sinjali kliniċi ta ’
Su 3.
ħ
Per dose of 2 ml:
ġ
120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant:
Classical Swine Fever, kif ukoll biex tnaqqas infezzjoni u tneħħija tal- virus CSF fil- beraħ. uth
941.4 mg/ 2 ml
2 ml gA
n tio 4.
7.
INDICATION(S)
METODU U MOD TA 'AMMINISTRAZZJONI
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical isa
Użu intramuskulari. tin
signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
8.
The duration of protection is 6 months. or
PARIR SABIEX TAMMINISTRA B' MOD KORRETT ke
5.
Ħ
None
Ċ Ċ
6.
ħ
A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine.
Amministra injezzjoni ta ’ 2 millilitri tal- vaċċin fil- fond fil- muskolu, fl - għonq wara l- widna.
Abscesses may be observed at the injection site.
Dejjem uża siringi u labar sterili. r Ma
site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
L- ewwel darba:
After administration of an overdose, local reactions at the injection site may be more pronounced. ke
Injetta b’ doża kull majjal, u għati t- tieni doża erba imgħat wara l - ewwel wahda. ġ Revaċċinazzjoni:
If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. r Ma
Jista ’ jintuża waqt it- tqala pero mhux evitat li l- virus tas- CSF jgħaddi mill- omm għall- feti.
15/ 17 8.
19/ 21 9.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
KONTRAINDIKAZZJONIJIET
2 ml Intramuscular use
EFFETTI MHUX MIXTIEQA
ed Vaccination scheme:
Nefħa li afna
Basic vaccination:
ġ ġ
Inject one dose per pig followed by a second injection 4 weeks after the first injection.
drabi tinżel waħedha tista ’ tinħoloq fis- sit tal- injezzjoni sa erba ’ imgħat wara l- injezzjoni. ieda fit -
Re-vaccination:
ġ
nd 9.
Ż
e Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Tiġmiegħ ta ’ materja taħt il- ġilda jista ’ jseħħ fis- sit tal- injezzjoni.
sp Administer 2 ml of vaccine deep intramuscularly in the neck area behind the ear.
pe jinokula fl- istess sit, huwa rakkomandat li t- tieni darba tlaqqam f’ post differenti.
Use sterile syringes and needles.
Reazzjonijiet qawwija jistgħu jiġu osservati jekk tagħti doża eċċessiva.
It is recommended to use a closed multiject vaccination system.
Jekk tinnota xi effetti oħra mhux mixtieqa, jekk jogħġbok informa lit- tabib veterinarju.
Su 10.
us 11.
WITHDRAWAL PERIOD
MIEN TA 'TIŻMIM Ż
Zero days
nS Xejn
n tio 11.
12.
Keep out of the reach and sight of children. isa
tio omm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Store in a refrigerator (2°C to 8°C).
Ż Aħżen f’ temperatura ta '2°Ċ – 8°Ċ.
Shelf-life after first broaching the bottle:
Tiffriżax. isa Perjodu ta ’ a na wara li jinfetaħ il- flixkun:
SPECIAL WARNINGS uth
TWISSIJIET SPEĊJALI or
To the user:
Ghal min se juża:
This product contains mineral oil.
Dan il- prodott fih ejt minerali.
If you are accidentally injected with this gA
f' ugiegh kbir u nefha specjalment jekk tinjetta f' gog jew subgħa u f' kazijiet rari jista jkun il - kawza li jkollok taqta 'subghajk jekk ma tikkonsultax tabib mal- ewwel.
product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tigi njettat bi zball b' dan il- prodott, fittex ghajnuna medika, anke jekk ammont zghir hafna gie njettat u hu l- fuljetta ta 'nformazzjoni mieghek.
If pain persists for more than 12 hours after medical examination, seek medical advice again. tin
Jekk l- ugiegh idum ghal aktar minn tnax il- siegha, wara gA
To the physician:
Ghat- 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 gew injettati ammonti g ar, injezzjoni bi ball ta ’ dan il -
Expert, PROMPT, surgical attention is required and may necessitate early incision ke
prodott tista 'tikkawża nefħa intensa, li tista' per eżempju tikkawża nekrozi iskimika u anke il- bżonn li tin
and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert ghandha tingħata mal- ewwel u jista ’ jkun hemm bżonn li jinfetah is- subgħa u tigi rrigata il- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa u t- tendin tal- muskolu. > ke
Vaccinate healthy animals only. r
Evita li tikkontamina. r
The product can be used during pregnancy but may not prevent transplacental transmission of Classical Ma
Huwa rakkomandat li tuża sistema magħluqa li tieħu aktar minn tilqima waħda M' hemmx informazzjoni dwar l- effett u l- effiċjenza ta din it- tilqima jekk tintuża flimkien ma kwalunkwe Ma
swine fever field virus from the sow to foetuses.
tilqim ieħor. Għaldaqstant huwa rakkommandat li ma tintuża l- ebda tilqima oħra meta qed jintuza dan il- prodott Tħallatx ma tilqim jew prodotti immunoloġiċi oħra.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
20/ 21 L- importazzjoni, bejgħ, provvista u / jew l- użu ta 'dan il- prodott mediċinali veterinarju huwa permess f’ kundizzjonijiet partikulari stabbiliti legalment mill- Komunita Ewropeja dwar kontrol tal - CSF (Direttiva nru.
It is therefore recommended that no other vaccines can be administered concurrently with the product.
80/ 217/ EEC kif ammendata).
Do not mix with any other vaccine or immunological product.
Kull persuna li turi l- intenzjoni li timporta, tbiegħ, tagħmel
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
d provvista jew tuża dan il- prodott għandu jkun awtorizzat mill- Awtorita Kompetenti tal- Pajjiż Membru.
ed 13.
de 14.
nd Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
TAGĦRIF DWAR RIMI TA ’ 'MEDIĊINA MHUX UŻATA JEW MATERJAL
e 14.
A IN
sp 09/ 06/ 2000
ŻĦ IEĦOR, JEKK IKUN IL- KAŻ
Su Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
n Mediċina veterinarja li ma ietx użata jew prodotti ohra li ntużaw għal din il- mediċina għandhom jintremew ġ skond kif titlob il- liġi tal- pajjiż.
15.
pe 15.
OTHER INFORMATION
us 19. 03. 2004
n For animal treatment only. tio As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2. isa
TAGĦRIF IEĦOR
50 ml/ 100 ml/ 250 ml multidose glass bottle 50 ml/ 100 ml/ 250 ml multidose PET bottle
B’ riżultat tal- għamla tal- vaċċin bhala subunit, vaċċinazzjoni ma toħloqx produzzjoni ta ’ antibodies
Not all pack sizes may be marketed. or uth gA tin r ke Ma
tio kontra antiġeni tal- virus CSF, lief dawk E2. ħ isa or uth gA tin ke r Ma
17/ 17
21/ 21
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) POSATEX
RAPPORT TA 'VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) POSATEX
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk trid iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament ta ’ l- annimal tiegħek, ikkuntattja lil - veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Posatex?
X’ inhu Posatex?
Posatex contains three active substances: orbifloxacin, mometasone furoate monohydrate and posaconazole.
Posatex fih tliet sustanzi attivi: orbifloxacin, mometasone furoate monohydrate u posaconzole.
Posatex is an ear drop suspension, white to off white in colour.
Posatex huwa sospensjoni ta ’ taqtir tal- widnejn, f’ kulur abjad jew abjad maqtugħ.
It is available in three pack sizes; 8.8, 17.5 and 35.1 ml bottles for dogs.
Jinsab disponibbli fi tliet daqsijiet ta ’ pakketti; fi fliexken għall- klieb ta ’ 8. 8ml, 17. 5ml u 35. 1ml.
What is Posatex used for?
Għal xiex jintuża Posatex?
Posatex is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa).
Postatex jintuża biex jitratta klieb li jsofru minn każijiet akuti jew rikorrenti ta ’ infezzjonijiet fil- widnejn (otite esterna).
It is given once a day for seven days.
Jingħata darba kuljum għal sebat ijiem.
The number of ear drops to use depends on the weight of the dog and varies from two to eight.
In- numru ta ’ taqtiriet tal - widnejn jiddependi fuq il- piż tal- kelb u jvarja minn tnejn sa tmienja.
The inside of the ear should be cleaned and dried before treatment.
Il- parti interna tal- widna għandha titnaddaf u tiġi xxuttata qabel it- trattament.
How does Posatex work?
Kif jaħdem Posatex?
Ear infections in dogs can be caused by bacteria or fungi.
L- infezzjonijiet tal- widnejn fil- klieb jistgħu jiġu kkawżati minn batterja jew fungi.
Two of the active substances in Posatex, orbifloxacin and posaconazole, work against the cause of the infection, while the third one, mometasone furoate monohydrate, works on the inflammation.
Ta ’ spiss iwasslu sabiex il- widna tkun infjammata (ħamra, minfuħa u tqabbad il- ħakk) Tnejn mis - sustanzi attivi f’ Posatex, orbifloxacin u posaconazole jaħdmu kontra l- kawża ta ’ l- infezzzjoni waqt li t- tielet waħda, mometasone furoate monohydrate taħdem fuq l- infjammazzjoni.
Orbifloxacin is an antibiotic that belongs to the group fluoroquinolones.
Orbifloxacin huwa antibijotiku li jappartjeni għall- grupp fluoroquinolones.
It works by blocking an enzyme called ‘ DNA gyrase’, which is important in allowing bacteria to make copies of their DNA.
Dan jaħdem billi jimblokka enżim imsejjaħ ‘ DNA gyrase ’, li huwa importanti fil- fatt li jħalli l- batterja sabiex jagħmlu kopji tad- DNA tagħhom.
By blocking DNA gyrase, orbifloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Billi jimblokka id- DNA gyrase, orbifloxacin jipprevjeni l - batterja milli joħolqu d- DNA u jwaqqafhom milli joħolqu proteini u jikbru li b’ hekk iwassal sabiex dawn imutu.
Posaconazole is an antifungal that belongs to the group triazoles.
Posaconazole hija sustanza kontra l- fungu li tappartjeni għall- grupp triazoles..
It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Din taħdem billi tipprevjeni l- iffurmar ta ’ ergosterol li huwa parti importanti mill - ħitan taċ- ċelloli tal- fungi.
Mometasone furoate monohydrate is a steroid, which is a type of substance that helps to reduce inflammation.
Mometasone furoate monohydrate huwa sterojdi li huwa tip ta ’ sustanza li tgħin fit- tnaqqis ta ’ l- infjammazzjoni.
How has Posatex been studied?
Kif ġie studjat Posatex?
Posatex has been studied in dogs in both laboratory and field trials.
Posatex ġie studjat fi klieb kemm fil- laboratorju kif ukoll fi provi kliniċi fuq il- post.
Two large field trials were conducted one in Europe and one in the USA.
Saru żewġ studji kbar fuq il- post, wieħed fl- Ewropa u l- ieħor l- Amerka.
In both studies the effectiveness of Posatex was compared with that of ear drops containing three similar active substances.
Fiż- żewġ studji l- effikaċja ta ’ Postaex tqabblet ma ’ dik tat- taqtiriet tal- widnejn li kien fihom tliet sustanzi attivi li kienu simili.
Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Ġie assenjat l- istess numru ta ’ klieb għal kull grupp ta ’ razza, età, sess u piż differenti.
What benefit has Posatex shown during the studies?
Liema bnefiċċju wera Posatex waqt l- istudji li ġew imwettqa?
Posatex at the recommended dose and following 7 days of treatment was as effective as the comparator medicine in improving the symptoms (redness, swelling, ear discharge, discomfort) of ear infections in dogs with acute or recurrent bacterial or fungal infections.
Fid- doża rakkomandata u wara 7 ijiem ta ’ trattament Posatex kien effikaċi daqs il- mediċina ta ’ tqabbil fit- titjib tas- sintomi (ħmura, nefħa, tnixxija mill- widna, sensazzjoni skomda) ta ’ l - infezzjonijiet tal- widnejn fil- klieb b’ infezzjonijiet batterjali jew tal- fungi akuti jew rikorrenti.
The ear drop suspension is easy to apply by the owner and therefore increased success in the treatment of an ear infection can be expected when the medicinal product is used as directed.
Is- sospensjoni tat- taqtiriet tal- widnejn hija faċli sabiex tingħata minn sid il- kelb u għalhekk għandu jiġi mistenni li jkun hemm progress tajjeb fit- trattament ta ’ l- infezzjoni tal- widnejn meta l- prodott mediċinali jingħata kif suppost.
What is the risk associated with Posatex?
X’ inhu r- riskju assoċjat ma ’ Posatex?
The use of ear preparations may be associated with damage to hearing, usually temporary and primarily in older dogs.
Ġiet innutata ħmura ħafifa fil- widna L- użu ta ’ preparazzjonijiet tal- widnejn jista ’ tkun ukolla assoċjat mal- ħsara fis- smigħ, normalment ta ’ natura temporanja jew ġeneralment fil- klieb li jkunu ixjeħ.
For a full list of all side-effects reported with Posatex, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Posatex, ara l- Fuljett ta ’ Tagħrif.
This veterinary medicine has been developed especially for dogs and is not for use in humans.
Din il- mediċina veterinarja ġiet żviluppata apposta għall- klieb u m’ għandhiex tintuża fuq il - bnedmin.
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Jekk persuna aċċidentalment tieħu l- mediċina, fittex l- għajnuna medika minnufih u uri l- fuljett tat- tagħrif jew it- tikketta lil tabib.
If accidental skin contact occurs, wash immediately with lots of water.
Jekk ikun hemm kuntatt aċċidentali mal- ġilda, laħlaħ minnufih b’ ħafna ilma.
Why has Posatex been approved?
Għaliex ġie approvat Posatex?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Posatex exceed its risks for the treatment of acute otitis externa and acute exacerbations of recurrent otitis externa in dogs and recommended that Posatex be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Posatex jisbqu r- riskji tiegħu għat- trattament ta ’ otite esterna akuta u taħrix akut ta ’ otite esterna rikorrenti fil- klieb u irrakkomanda li Posatex jingħata awtorizzazzjoni biex jitqiegħed fis- suq.
Other information about Posatex:
Iktar tagħrif dwar Posatex:
The European Commission granted a marketing authorisation valid throughout the European Union, for Posatex to S-P Veterinary, United Kingdom on 23/ 06/ 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Posatex lil S- P Veterinary, fir- Renju Unit fil- 23/ 06/ 2008.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l- istat tal- preskrizzjoni ta ’ dan il- prodott tista ’ tiġi kkonsultata fuq it- tikketta jew fuq il- qoxra tal- pakkett..
Orbifloxacin 8.5 mg/ ml Mometasone furoate (as monohydrate) 0.9 mg/ ml Posaconazole 0.9 mg/ ml
Orbifloxacin 8. 5mg/ ml Mometasone furoate (bħala Monohydrate) 0. 9mg/ ml Posaconazole 0. 9mg/ ml
Ear drops, suspension
Qtar tal- widnejn Klieb suspensjoni
Auricular use
Biex Jingħata ġol
Orbifloxacin 8.5 mg/ ml Ear drops, Mometasone furoate (as suspension monohydrate) 0.9 mg/ ml Posaconazole 0.9 mg/ ml
Orbifloxacin 8. 5mg/ ml Mometasone furoate (bħala Monohydrate) 0. 9mg/ ml Posaconazole 0. 9mg/ ml
Dogs
Qtar tal- widnejn Klieb suspensjoni
Posatex, ear drops suspension for dogs
Posatex, suspensjoni ta ’ qtar tal- widnejn għall- klieb
Orbifloxacin Mometasone furoate (as monohydrate) Posaconazole
8. 5 mg/ ml
8.5 mg/ ml 0.9 mg/ ml 0.9 mg/ ml
0. 9 mg/ ml
Paraffin liquid
Likwidu tal- paraffin
Ear drops suspension White to off-white oily suspension
Suspensjoni ta ’ qtar tal- widnejn Suspensjoni żejtnija ta ’ lewn abjad jew bajdani.
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Kura ta ’ otite esterna akuta u aggravamenti akuti ta ’ otite esterna repetittivi, assoċjati ma ’ batterji suxxettibbli għal orbifloxaċin u fungi suxxettibbli għal posakonazol, b’ mod partikulari Malassezia pachydermatis.
Do not use if the eardrum is perforated.
Tużax jekk it- tanbur huwa mtaqqab.
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents and to other fluoroquinolones.
Tużax f’ każ ta ’ sensittività eċċessiva għal xi waħda mis- sustanzi tal- prodott mediċinali veterinarju, għall- kortikosterojdi, għal sustanzi antifungali azole oħrajn u florokwinolons oħrajn.
See section 4.7 (Use during pregnancy, lactation) of this SPC.
Ara sezzjoni 4. 7 (Użu fit- tqala u fi żmien il- ħalib) ta ’ dan l- KPQ.
Bacterial and fungal otitis is often secondary in nature.
Otite batterjali u bil- fungus ta ’ spiss tkun sekondarja fin- natura tagħha.
The underlying cause should be identified and treated.
Il- kawża bażika għandha tkun identifikata u kkurata.
2/ 18 4.5 Special precautions for use
4. 5 Prekawzjonijiet speċjali għall- użu
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Li wieħed jorbot ħafna fuq klassi waħda ta ’ antibijotiċi jista ’ jirriżulta fl- induzzjoni ta ’ reżistenza f’ popolazzjoni batterjali.
It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics.
2/ 18 kundizzjonijiet kliniċi, li ma jkunux irrispondew tajjeb jew li jkunu mistennija li ma jirrispondux tajjeb għal klassijiet oħrajn ta ’ antibijotiċi.
Use of the product should be based on susceptibility testing of isolated bacteria, and/ or other appropriate diagnostic tests.
L- użu tal- prodott għandu jkun ibbażat fuq l- ittestjar tas- suxxettibbilità ta ’ batterji iżolati, u/ jew testijiet dijanjostiċi oħrajn.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
Il- mediċini tal- klassi ta ’ kwinolon kienu assoċjati ma ’ tgħawwir fil- qarquċa ta’ ġogi li jerfgħu l- piż u forom oħrajn ta ’ artropatija f’ annimali immaturi ta ’ diversi speċi.
Therefore do not use in animals less than 4 months of age.
Tużax fuq klieb li jkollhom inqas minn 4 xhur.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.
L- użu fit- tul u intensiv ta ’ preparazzjoni ta ’ kortikosterojdi topiċi hi magħrufa li tikkawża effetti lokali u sistemiċi, li jinkludu t- trażżin tal- funzjoni adrenali, il- ġilda tirqaq u dewmien fil- fejqan tal- feriti.
See section 4.10 Overdose.
Ara sezzjoni 4. 10 Doża eċċessiva.
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Qabel ma l- prodott mediċinali veterinarju jiġi applikat, il- kanal estern tas- smigħ irid jiġi eżaminat bir- reqqa biex ikun żgurat li t- tanbur tal- widna ma jkunx imtaqqab, sabiex ikun evitat ir- riskju tat - trasmissjoni ta ’ l- infezzjoni lill- parti tan- nofs tal- widnejn u biex tiġi evitata ħsara lill- apparat tal - koklea u dak vestibulari.
Wash hands carefully after applying the veterinary medicinal product.
Aħsel idejk bir- reqqa wara li tapplika l- prodott mediċinali veterinarju.
Avoid skin contact.
Evita l- kuntatt mal- ġilda.
In case of accidental exposure, rinse the affected area with copious quantities of water.
F’ każ ta ’ espożizzjoni aċċidentali, laħlaħ iż- żona affettwata bi kwantitajiet kbar ta ’ ilma.
Mild erythematous lesions have been observed.
Kienu osservati rqajja ta ’ ħmura ħafifa.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
L- użu ta ’ preparazzjonijiet awrikolari jista ’ jkun assoċjat ma ’ indeboliment fis- smigħ, li normalment ikun temporanju, u li jseħħ primarjament fi klieb xjuħ.
4.7 Use during pregnancy, lactation
4. 7 Użu fit- tqala u fi żmien il- ħalib
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Do not use during the whole or part of the pregnancy.
Tużax matul it- tqala kollha jew f’ xi parti mit- tqala.
The use of the veterinary medicinal product is not recommended during lactation.
L- użu tal- prodott mediċinali veterinarju mhuwiex rakkomandat waqt it- treddigħ.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin.
Studji fil- laboratorju fuq ġriewi wrew evidenza ta ’ artropatija wara l- għoti sistemiku ta ’ orbifloxaċin.
Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Il- fluorokwinolons huma magħrufa li jgħaddu minn ġol- plaċenta u jitqassmu fil- ħalib.
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Ma sarux studji biex jiddeterminaw l- effett ta ’ orbifloxaċin fuq il- fertilità tal- klieb.
Do not use in breeding animals.
Tużax fuq annimali tat- tgħammir.
Compatibility with ear cleaners has not been demonstrated.
Ma ġiet murija l- ebda kompatibilità ma ’ sustanzi li jnaddfu l- widnejn.
Concurrent use with an ear cleaner with a high pH is not recommended.
L- użu fl- istess ħin ma ’ sustanza li tnaddaf il- widnejn li jkollha pH għoli mhuwiex rakkomandat.
3/ 18 4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ amministrazzjoni
Auricular use.
Għal użu fil- widnejn.
One drop contains 244 µg orbifloxacin, 24 µg mometasone furoate and 24 µg posaconazole.
Qatra waħda fiha 244 µg ta ’ orbifloxaċin, 24 µg ta ’ mometasone furoate u 24 µg ta ’ posakonazol.
The external ear canal should be meticulously cleaned and dried before treatment.
3/ 18 Il- kanal estern tal- widna għandu jitnaddaf bir- reqqa u jitnixxef qabel il- kura.
Excess hair around the treatment area should be cut.
Xagħar eċċessiv madwar iż- żona li tkun ser tiġi trattatagħandu jinqata ’.
Shake the bottle thoroughly before use.
Ħawwad il- flixkun tajjeb qabel l- użu.
Dogs weighing under 2 kg, apply 2 drops to the ear once a day.
Għal klieb li jiżnu inqas minn 2 kg: applika 2 qatriet ġol- widna darba kuljum.
Dogs weighing 2-15 kg, apply 4 drops to the ear once a day.
Għal klieb li jiżnu 2- 15 kg: applika 4 qatriet ġol- widna darba kuljum.
Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Għal klieb li jiżnu 15 kg jew iżjed: applika 8 qatriet ġol- widna darba kuljum.
Use at room temperature (do not instill cold material into the ear).
Uża fit- temperatura tal- kamra (tixħitx materjal kiesaħ ġol- widnejn).
Treatment should continue for 7 consecutive days.
Il- kura għandha tkompli għal 7 ijiem konsekuttivi.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate the lower part of the ear canal.
Wara l- applikazzjoni, il- bażi tal- widna tista ’ tiġi mmassaġġjata għal ftit tal- ħin biex tħalli l - preparazzjoni tippenetra ġol- parti t’ isfel tal- kanal tal- widna.
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test.
L- għoti tad- doża rakkomandata (4 qatriet f’ kull widna) 5 darbiet kuljum għal 21 jum konsekuttiv lil klieb li jiżnu 7. 6 sa 11. 4 kg, ikkawża tnaqqis żgħir fir- rispons tal- kortisol tas- serum wara l- għoti ta ’ l - ormon adrenokortikotropiku (ACTH) f’ test ta ’ l- istimulazzjoni ACTH.
Discontinuation of treatment will result in a complete return to normal adrenal response.
It- twaqqif tal- kura ser jirriżulta f’ ritorn komplet għan- normal tar- rispons adrenali.
4.11 Withdrawal period(s)
4. 11 Perjodu ta ’ tiżmim
5 PHARMACOLOGICAL PROPERTIES
5 KWALITAJIET IMMUNOLOĠIĊI
Otologic - Corticosteroids and anti-infectives in combination.
Otoloġiċi - Kortikosterojdi u anti- infettivi flimkien.
Orbifloxacin is a synthetic broad-spectrum bactericidal agent classified as a quinolone carboxylic acid derivative, or more specifically, a fluoroquinolone.
Orbifloxaċin hu sustanza batteriċida sintetika bi spektrum wiesgħa li hi kklassifikata bħala kwinolon, derivattiv tal- aċidu karbossiliku, jew iktar speċifikament, fluorokwinolon.
The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA.
L- azzjoni batteriċida ta ’ orbifloxaċin tirriżulta mill- interferenza ta ’ l- enżimi DNA topoisomerejs II (DNA- ġajrejs) u DNA topoisomerejas IV li huma meħtieġa għas- sintesi u l- manteniment tad- DNA tal- batterja.
Such impairment disrupts replication of the bacterial cell, leading to rapid cell death.
Dan l - indeboliment itellef ir- replikazzjoni taċ- ċellula tal- batterja, u jwassal għal mewt ta ’ malajr taċ- ċellula.
The rapidity and extent of killing are directly proportional to the drug concentration.
Ir- rapidità u l- grad tal- qtil huma proporzjonalment diretti mal- konċentrazzjoni tal- mediċina.