qanastek/EMEA-V3 huggingface dataset:
499.5 mg metaflumizone and 499.5 mg amitraz
499. 5 mg metaflumizone u 499. 5 mg amitraz
Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 3. 33 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 3. 33 ml
17/ 39 9.
19/ 43 9.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament tal- annimali biss - għandu jingħata biss bi preskrizzjoni medika.
EU/ 2/ 06/ 065/ 005 – 1 blister card of 3 pipettes of 3.33 ml EU/ 2/ 06/ 065/ 006 – 2 blister cards of 3 pipettes of 3.33 ml
EU/ 2/ 06/ 065/ 005 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 3. 33 ml EU/ 2/ 06/ 065/ 006 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta ’ 3. 33 ml
17.
20/ 43 17.
18/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21/ 43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 – 40.0 kg}
ProMeris Duo 799. 5 mg + 799. 5 mg għall- użu lokalizzat għall- klieb kbar {25. 1 – 40. 0 kg}
Each 5.33 ml pipette delivers:
Kull pipetta ta ’ 5. 33 ml tagħti:
799.5 mg metaflumizone and 799.5 mg amitraz
799. 5 mg metaflumizone u 799. 5 mg amitraz
Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 5. 33 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 5. 33 ml
19/ 39 9.
22/ 43 9.
For further information see package leaflet.
Għall- akar tagħrif ara l- fuljett ta 'tagħrif fil- pakkett.
EU/ 2/ 06/ 065/ 007 – 1 blister card of 3 pipettes of 5.33 ml EU/ 2/ 06/ 065/ 008 – 2 blister cards of 3 pipettes of 5.33 ml
EU/ 0/ 00/ 000/ 000 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 5. 33 ml EU/ 0/ 00/ 000/ 000 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta ’ 5. 33 ml
20/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
23/ 43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 – 50.0 kg}
ProMeris Duo 999 mg + 999 mg għall- użu lokalizzat għall- klieb kbar ħafna {40. 1 – 50. 0 kg}
Each 6.66 ml pipette delivers:
Kull pipetta ta ’ 6. 66 ml tagħti:
999 mg metaflumizone and 999 mg amitraz
999 mg metaflumizone u 999 mg amitraz
Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 6. 66 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 6. 66 ml
EU/ 2/ 06/ 065/ 009 – 1 blister card of 3 pipettes of 6.66 ml EU/ 2/ 06/ 065/ 010 – 2 blister cards of 3 pipettes of 6.66 ml
EU/ 2/ 06/ 065/ 009 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 6. 66 ml EU/ 2/ 06/ 065/ 010 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta’ 6. 66 ml
22/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
FOIL 0.67 ml
FOLJA 0. 67 ml
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
ProMeris Duo 100. 5 mg + 100. 5 mg għall- Użu Lokalizzat għall- klieb żgħar {≤ to 5 kg}
Metaflumizone 100.5 mg and amitraz 100.5 mg
Metaflumizone 100. 5 mg u amitraz 100. 5 mg
Spot-on use
Għal użu minn barra biss.
23/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
FOIL 1.33 ml
FOLJA 1. 33 ml
ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1-10.0 kg}
ProMeris Duo 199. 5 mg + 199. 5 mg għall- Użu Lokalizzat għall- klieb ta’ daqs medju {5. 1 – 10. 0 kg}
Metaflumizone 199.5 mg and amitraz 199.5 mg
Metaflumizone 199. 5 mg u amitraz 199. 5 mg
24/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
FOIL 3.33 ml
FOLJA 3. 33 ml
ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs {10.1– 25.0 kg}
ProMeris Duo 499. 5 mg + 499. 5 mg għall- Użu Lokalizzat għall- klieb ta’ daqs medju/ kbir {10. 1 – 25. 0 kg}
Metaflumizone 499.5 mg and amitraz 499.5 mg
Metaflumizone 499. 5 mg u amitraz 499. 5 mg
25/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
FOIL 5.33 ml
FOLJA 5. 33 ml
ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 – 40.0 kg}
ProMeris Duo 799. 5 mg + 799. 5 mg għall- Użu Lokalizzat għall- klieb kbar {25. 1 – 40. 0 kg}
Metaflumizone 799.5 mg and amitraz 799.5 mg
Metaflumizone 799. 5 mg u amitraz 799. 5 mg
26/ 39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30/ 43 MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
FOIL 6.66 ml
FOLJA 6. 66 ml
ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 – 50.0 kg}
ProMeris Duo 999 mg + 999 mg għall- Użu Lokalizzat għall- klieb kbar ħafna {40. 1 – 50. 0 kg}
Metaflumizone 999 mg and amitraz 999 mg
Metaflumizone 999 mg u amitraz 999 mg
27/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
31/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for small dogs
Għall- klieb żgħar
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT SKOND IL- PIŻ, VOLUM, JEW NUMRU TA ’ DOŻI
100.5 mg + 100.5 mg
100. 5 mg + 100. 5 mg
EXP {month/ year} >
EXP {Xahar/ sena}
28/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
32/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for medium sized dogs
Għall- klieb ta ’ daqs medju
199.5 mg + 199.5 mg
199. 5 mg + 199. 5 mg
LOT {number}
Lot {numru}
29/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
33/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for medium/ large sized dogs
Għall- klieb ta ’ daqs medju/ żgħir
499.5 mg + 499.5 mg
499. 5 mg + 499. 5 mg
30/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
34/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for large dogs
Għall- klieb kbar
799.5 mg + 799.5 mg
799. 5 mg + 799. 5 mg
31/ 39 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
35/ 43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for extra large dogs
Għall- klieb kbar ħafna
33/ 39 PACKAGE LEAFLET
37/ 43 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
ProMeris Duo għall- Użu Lokalizzat għall- klieb
Marketing authorisation holder Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp L- Olanda
18, Via Franco Gorgone 95030 Catania Italy
18, Via Franco Gorgone 95030 Catania L- Italja
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
ProMeris Duo 100. 5 mg + 100. 5 mg għall- Użu Lokalizzat għall- klieb żgħar ProMeris Duo 199. 5 mg + 199. 5 mg għall- Użu Lokalizzat għall- klieb ta ’ daqs medju ProMeris Duo 499. 5 mg + 499. 5 mg għall- Użu Lokalizzat għall- klieb ta ’ daqs medju / kbir ProMeris Duo 799. 5 mg + 799. 5 mg għall- Użu Lokalizzat għall- klieb kbar ProMeris Duo 999 mg + 999mg għall- Użu Lokalizzat għall- klieb kbar hafna
Metaflumizone (mg)
ProMeris Duo għall- Użu Lokalizzat għall - klieb għall- klieb żgħar (≤ 5 kg)
Amitraz (mg)
Volum (ml) 0. 67
ProMeris Duo Spot-on for Small Dogs (≤ 5 kg)
Metaflumizone (mg) 100. 5
ProMeris Duo Spot-on for Medium Sized Dogs - (5.1 – 10.0 kg)
Amitraz (mg) 100. 5
ProMeris Duo Spot-on for Medium/ Large Sized Dogs (10.1 – 25.0 kg)
għall- klieb ta ’ daqs medju (5. 1 – 10. 0 kg) għall- klieb ta ’ daqs medju/ kbir (10. 1 – 25. 0 kg) għall- klieb kbar (25. 1 – 40. 0 kg) għall- klieb kbar ħafna (40. 1 – 50. 0 kg)
ProMeris Duo Spot-on for Large Dogs (25.1 – 40.0 kg)
1. 33 3. 33 5. 33 6. 66
999
199. 5 499. 5 799. 5 999
For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis) and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulates and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs.
Għall- kura u l- prevenzjoni ta ’ infestazzjonijiet minn briegħed (Ctenocephalides canis u C. felis) u qurdien (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus u Dermacentor variabilis), u għall- kura ta ’ demodikosi (ikkawżata minn Demodex spp.) u tal- qamel (Trichodectes canis) fil- klieb.
CONTRAINDICATIONS
38/ 43 5 KUNTRADIZZJONIJIET
Do not administer to cats.
Tagħtix lill- qtates.
Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Tagħtix lill- klieb morda jew dgħajfa jew klieb li qed isofru minn stress għas- sħana.
ADVERSE REACTION
EFFETTI MHUX MIXTIEQA
Most of these signs are due to alpha-2-adreno-receptor agonist effects.
Il- biċċa l- kbira ta ’ dawn is- sinjali huma minħabba l- effetti agonisti tar- riċettur alpha- 2 - adreno.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side-effects.
Jekk is- sintomi huma severi jew jippersistu jista ’ jintuża l- antagonist tar- riċettur alpha- 2 - adreno atipamezole hydrochloride f’ doża ta ’ 0. 2 mg/ kg piż tal- ġisem permeżż ta ’ injezzjoni ġol - muskoli biex ireġġa ’ lura dawn l- effetti mhux mixtieqa.
35/ 39
39/ 43
Weight Range of
Firxa ta ’ Piż tal -
Dog (kg)
Kelb (kg)
ProMeris Duo
ProMeris Duo għall- Klieb Żgħar
5.1 – 10.0
5. 1 – 10. 0
ProMeris Duo
ProMeris Duo għall- Klieb ta ’ daqs Medju
10.1 – 25.0
10. 1 – 25. 0
ProMeris Duo Spot-on for Medium/ Large Sized Dogs
ProMeris Duo għall- għall- Klieb ta ’ daqs Medju/ Kbir
25.1 – 40.0
25. 1 – 40. 0 40. 1 – 50. 0
ProMeris Duo Spot-on for Large Dogs
ProMeris Duo għall- Klieb Kbar ProMeris Duo għall- Klieb Kbar Ħafna
40.1 – 50.0
5. 33 6. 66
The top of the tip will fold back against the pipette.
It- tarf ta ’ fuq tal- ponta tintrewa lura ma ’ wara tal- pipetta.
Apply the content of the pipette to a single spot on the skin of the dog at the base of the skull.
Ferraq il- pil u applika il- kontenut tal- pipetta f’ post wieħed fuq il- ġilda tal- kelb fil- bażi tar- ras.
Do not apply the medicine to the surface of the dog’ s hair coat.
Tapplikax il- prodott mediċinali veterinarju fuq il- wiċċ tal- pil tal- kelb.
For treatment of biting lice a single dose should be sufficient.
Għall- kontroll ottimali ta ’ infestazzjoni tal- briegħed u/ jew qurdien il- prodott għandu jingħata f’ intervalli ta ’ xahar matul l- istaġun tal- briegħed u/ jew qurdien, jew il- programm ta ’ kura jista ’ jiġi bbażat fuq is- sitwazzjoni epidemjoloġika lokali.
Most lice are killed within 7 days.
Il- biċċa l- kbira tal- qamel imut fi żmien 7t ijiem.
36/ 39 For treatment of demodicosis, the product should be administered at monthly intervals until clinical signs resolve.
Għall- kura ta ’ demodikosi, l- prodott għandu jiġi amministrat f’ intervalli ta ’ kull xahar sakemm is- sinjali kliniċi jgħaddu.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.
40/ 43 Il- prodott mediċinali veterinarju jipprevjeni l- infestazzjoni mill- briegħed sa 6 ġimgħat u l - infestazzjoni tal- qurdien għal 4 ġimgħat wara amministrazzjoni waħda.
For use only under the supervision of a veterinary supervision.
Għall- użu taħt is- superviżjoni ta ’ kirurgu veterinarju biss.
The veterinary medicinal product remains effective if the animal becomes wet.
Il- prodott mediċinali veterinarju jibqa’ effettiv jekk l- annimal jixxarrab.
However, prolonged, intense exposure to water should be avoided.
Iżda, espożizzjoni fit- tul u intensa ghall- ilma għandha tiġi evitata.
Do not store above 25 °C.
Taħżinx f' temperatura 'l fuq minn 25°C.
Do not use after the expiry date stated on the carton after “ EXP”.
Tużax wara d- data tal- iskadenza fuq il- pakkett wara {JIS}.
Stored pipettes must be kept in the intact foil package.
Il- pipetti maħżuna għandhom jinżammu fil- pakkett tal - folja intatt.
This product should not be administered by children.
Dan il- prodott m’ għandux jingħata mit- tfal.
37/ 39 Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Amitraz huwa inibitur ta ’ monoamine oxidase (MOAI); għalhekk, persuni li qed jieħdu mediċini li fihom MOAI għandhom jimmaniġġjaw dan il- prodott b’ attenzjoni speċjali.
Avoid direct contact with treated animals until the application site is dry.
41/ 43 Evita kuntatt dirett ma ’ annimali trattati sakemm il- post tal- applikazzjoni jinxef.
Children should not be allowed to have contact with treated animals until the application site is dry.
It- tfal m’ għandhomx jitħallew li jkollhom kuntatt ma ’ annimali trattati qabel ma l- post ta ’ applikazzjoni jinxef.
If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
Jekk jiġu nnutati effetti ħżiena wara espożizzjoni għall- prodott, fittex assistenza medika minnufiħ, u uri l- pakkett ta ’ barra tal- prodott lit- tabib.
Wash hands thoroughly after use.
Aħsel l- idejn sew wara l- użu.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kull mediċina veterinarja li ma ġietx użata jew skart miġbur minn dawn il- prodotti mediċinali veterinarji għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Il- prodott mediċinali veterinarju m’ għandux jitħalla jmur man- nixxigħat tal- ilma għax dan jista ’ jkun ta 'periklu għall- ħut u ħlejqiet oħra akwatici.
Carefully dispose of used pipettes immediately after use.
Armi b’ kawtela pipetti wżati mmedjatament wara l- użu.
DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV FIL - PAKKETT
Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.
Kull qawwa tal- prodott mediċinali veterinarju hija disponibbli f’ kaxxi b’ pakkett f’ folja waħda ta ’ 3 pipetti u f’ kaxxi b’ żewġ pakketti f’ folja ta ’ 3 pipetti.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet tal- pakketti kollha jitqegħdu fis- suq.
ProMeris 160 mg Spot-on solution for small cats ProMeris 320 mg Spot-on solution for large cats
ProMeris 160 mg soluzzjoni għall- Użu Lokalizzat għall- qtates żgħar ProMeris 320 mg soluzzjoni għall- Użu Lokalizzat għall- qtates kbar
Active substances Each ml contains 200 mg metaflumizone.
Kull ml fih 200 mg metaflumizone.
Each unit dose (pipette) of ProMeris delivers:
Kull unità ta ’ doża (pipetta) ta ’ ProMeris tagħti:
ProMeris for Small Cats (≤ 4 kg)
ProMeris għall- Qtates Żgħar (≤ 4 kg)
ProMeris for Large Cats (> 4 kg)
ProMeris għall- Qtates Kbar (> 4 kg)
qs to 100 ml
qs sa 100 ml
Cats over 8 weeks of age.
Qtates b’ età ’ l fuq minn 8 ġimgħat
Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Għall- kura u prevenzjoni ta ’ infestazzjonijiet minn briegħed (Ctenocephalides canis u C. felis) fil - qtates.
Do not administer to kittens under 8 weeks of age.
Tagħtix lill- frieħ ta ’ qtates taħt l- età ta ’ 8 ġimgħat.
4.4 Special warnings
2 4. 4 Twissijiet speċjali
Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
Evita l- kuntatt ma ’ l- għajnejn tal- qattus u evita inġestjoni orali mill- annimal.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Għall- kontroll ottimali tal- problemi tal- briegħed f’ dar li hemm aktar minn annimal wieħed, l- annimali kollha fid- dar għandhom jiġu kkurati b’ insettiċida xieraq.
In addition it is recommended to treat the environment with a suitable insecticide.
Barra minn hekk huwa rakkomandat li l - ambjent jiġi ttrattat b’ insettiċida xieraq.
2 4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
In sick or debilitated animals, use only according to the benefit/ risk assessment.
F’ annimali morda jew dgħajfa, uża biss skond l- analiżi tal- benefiċċji/ riskji.
It is important to apply the dose to an area where the animal cannot lick it off.
Huwa importanti li tapplika d- doża f’ post fejn l- annimal ma jistax jilagħqu u jneħħih.
Do not allow animals to groom each other following treatment.
Tħallix l - annimali jilagħqu lil xulxin wara l- kura.
Avoid direct contact with skin, eyes or mouth.
Evita kuntatt dirett mal- ġilda, għajnejn jew ħalq.
In case of accidental spillage onto skin, wash off immediately with soap and water.
F’ każ ta ’ tixrid aċċidentali fuq il- ġilda, aħsel minnufiħ bis- sapun u bl- ilma.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
Jekk bi żball il- prodott mediċinali veterinarju jidħol fl- għajnejn, dawn għandhom jitlaħalħu sew bl- ilma.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Tpejjipx, tixrobx jew tiekolx waqt li qed timmaniġġja l- prodott mediċinali veterinarju.
Children should not be allowed to play with treated animals until the application site is dry.
It- tfal m’ għandhomx jitħallew li jkollhom kuntatt ma ’ annimali trattati qabel ma l- post tal - applikazzjoni jinxef.
It is therefore recommended to treat the animals during the evening and that recently treated animals are not allowed to sleep with owners, especially children.
Għalhekk huwa rakkomandat li l- annimali jiġu trattati fil- għaxija u li annimali li ġew trattati reċentement ma jitħallewx jorqdu ma ’ sidhom, speċjalment tfal.
Hypersalivation may occur if the animal licks the application site immediately after treatment.
Tista ’ sseħħ ipersalivazzjoni jekk l- annimal jilgħaq il- post ta ’ l- applikazzjoni eżatt wara it- trattament.
The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site.
L- applikazzjoni tal- prodott mediċinali veterinarju tista ’ tipproduċi dehra temporanjament żejtnija u tagħqid jew ippuntar tal- pil fil- post ta ’ applikazzjoni.
This is normal and will generally resolve within 1 – 4 days after administration.
Dan huwa normali u ġeneralment jgħaddi f’ 1 – 4 ġranet wara l- applikazzjoni.
These changes do not affect the safety or efficacy of the veterinary medicinal product.
Dawn il- bidliet ma jaffettwawx is - sigurtà u l- effikaċja tal- prodott mediċinali veterinarju.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in queens.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Laboratory studies with metaflumizone in rats and/ or rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Studji fil- laboratorju b’ metaflumizone fil- firien u/ jew fniek ma pprovdewx evidenza ta 'ħsara fit- tqala, ħsara lill- fetu jew ħsara lill- omm.
Use only according to the benefit/ risk assessment by the responsible veterinarian.
Uża biss skond l- analiżi ta ’ benefiċċji/ riskju minn veterinarju responsabbli.
3
3 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Weight Of Cat (kg)
Xejn li hu magħruf.
Pipette size to be used
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Volume (ml)
Dożaġġ:
≤ 4 > 4
Piż tal- Qattus (kg) ≤4 > 4
ProMeris for Small Cats ProMeris for Large Cats
Daqs tal- pipetta li għandha tintuża ProMeris għall- Qtates Żgħar ProMeris għall- Qtates Kbar
0.80 1.60
Volum (ml) 0. 80 1. 60
Apply the content of the pipette to a single spot on the skin of the cat’ s neck at the base of the skull.
Applika il- kontenut tal- pipetta f’ post wieħed fuq il- ġilda fl- għonq tal- qattus fil- bażi tar- ras.
Part the fur on the cat's neck at the base of the skull until the skin is visible.
Ferraq il- pil fl- għonq tal- qattus fil- bażi tar- ras sakemm tidher il- ġilda.
Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.
Poġġi l- ponta tal- pipetta fuq il - ġilda u għafas il- pipetta sabiex tbattal il- kontenut kollu tagħha.
Do not apply the veterinary medicinal product to the surface of the cat’ s hair coat.
Tapplikax il- prodott mediċinali veterinarju fuq il- wiċċ tal- pil tal- qattus.
For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Għall- kontroll ottimali ta ’ infestazzjoni tal- briegħed, il- prodott mediċinali veterinarju jista ’ jingħata f’ intervalli ta ’ 4 – 6 ġimgħat tul l- istaġun tal- briegħed jew il- programm ta ’ kura jista ’ jiġi bbażat fuq is- sitwazzjoni epidemjoloġika lokali.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks following a single administration depending on the level of environmental rechallenge.
Il- prodott mediċinali veterinarju iwaqqaf l- infestazzjoni mill- briegħed sa 6 ġimgħat wara amministrazzjoni waħda skond il- livell ta ’ infestazzjoni mill- ġdid tal- ambjent.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
L- ebda effetti avversi ma kienu osservati fi qtates b’ età ta ’ 8 ġimgħat jew aktar ikkurati 7 darbiet f’ intervalli ta ’ ġimagħtejn b’ 3- 5 darbiet id- doża rakkomandata.
ATC Vet Code QP 53AX25
Kodici ATĊ veterinarja QP 53AX25
Metaflumizone is an ectoparasiticide belonging to the semicarbazone group of compounds.
Metaflumizone huwa ektoparassiċida li jagħmel parti mill- grupp ta ’ sustanzi semicarbazone.
Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair.
Metaflumizone jaħdem kontra l- briegħed minħabba espożizzjoni mhux sistemika tal- parassiti fuq il- ġilda u l- pil.
After topical administration at a single site on the cat’ s neck at the base of the skull, metaflumizone is rapidly distributed throughout the surface of the skin.
Wara amministrazzjoni topika f’ post wieħed fuq l- għonq tal- qattus fil- bażi tar- ras, metaflumizone iddistribwixxa ruħu malajr mal- wiċċ kollu tal- ġilda.
Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days post- treatment.
Konċentrazzjonijiet massimi fil- pil intlaħqu ġeneralment f’ madwar ġurnata sa tnejn wara l- kura u naqsu b’ mod gradwali tul 56 ġurnata wara it - trattament.
Metaflumizone was still measurable in the hair 56 days following treatment.
Metaflumizone xorta seta ’ jitkejjel fil- pil 56 ġurnata wara l- kura.
These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
Dawn ir- riżultati huma konsistenti ma ’ studji ta ’ l- effikaċja fil- laboratorju li wrew attività sa 56 ġurnata wara it- trattament.
After topical administration at a single site on the cat’ s neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Wara amministrazzjoni topika f’ post wieħed fuq l- għonq tal- qattus fil- bażi tar- ras, livelli fil- plażma ta ’ metaflumizone kienu baxxi wisq biex jitħallew li ssir kalkolazzjoni ta ’ parametri farmakokinetiċi stàndard.
See section 6.6
Ara sezzjoni 6. 6
30 months
30 il- xahar.
Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħażen 5 Taħżinx f' temperaturi ogħla minn 25 °C
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package.
Il- prodott mediċinali veterinarju huwa ppakkjat f’ dożi individwali f’ pipetti tal- plastik trasparenti li huma ippakkjati mill- ġdid f’ pakkett tal- fojl ta ’ l- aluminju.
Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes
Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 0. 80 ml Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 1. 60 ml
5 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew skart idderivat minn dawn il- prodotti mediċinali veterinarji għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Fort Dodge Animal Health Holland CJ van Houtenlaan 36 1381 CP Weesp, The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp, L- Olanda
19 December 2006
19 ta ’ Diċembru 2006
7 December 2007
7 ta ’ Diċembru 2007
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
Carton box for 1 blister card -Carton box for 2 blister cards
Kaxxa tal- kartun b’ pakket f’ folja – Kaxxa tal- kartun b’ 2 pakketti f’ folja
ProMeris 160 mg Spot-on for small cats {< 4 kg}
ProMeris 160 mg għall- Użu Lokalizzat għall- qtates żgħar {< 4 kg}
Each 0.80 ml pipette delivers:
Kull pipetta ta ’ 0. 80 ml tagħti:
Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 0. 80 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 0. 80 ml
For cats over 8 weeks of age.
Għall- qtates b’ età ’ l fuq minn 8 ġimgħat.
For the treatment and prevention of infestations by fleas.
Għall- kura u prevenzjoni ta ’ infestazzjonijiet minn briegħed.
Do not administer to kittens under 8 weeks of age.
Tagħtix lill- frieħ tal- qtates taħt l- età ta ’ 8 ġimgħat.
Consult your veterinarian before using the veterinary medicinal product on pregnant or lactating cats, or on sick or debilitated cats.
Kellem lill- veterinarju qabel ma tuża l- prodott mediċinali veterinarju fuq qtates tqal jew li qed ireddgħu, jew qtates li huma morda jew dgħajfa.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni medika.
EU/ 2/ 06/ 064/ 001 – 1 blister card of 3 pipettes of 0.80 ml EU/ 2/ 06/ 064/ 002 – 2 blister cards of 3 pipettes of 0.80 ml
EU/ 2/ 06/ 064/ 001 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 0. 80 ml EU/ 2/ 06/ 064/ 002 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta ’ 0. 80 ml
Carton box for 1 blister card Carton box for 2 blister cards
Kaxxa tal- kartun b’ pakket f’ folja Kaxxa tal- kartun b’ 2 pakketti f’ folja
ProMeris 320 mg Spot-on for large cats {> 4 kg}
ProMeris 320 mg għall- Użu Lokalizzat għall- qtates kbar {> 4 kg}
Each 1.60 ml pipette delivers:
Kull pipetta ta ’ 1. 60 ml tagħti:
Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 1. 60 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 1. 60 ml
Do not administer to kittens under 8 weeks of age.
ŻMIEN TA 'TIŻMIM
Consult your veterinarian before using the veterinary medicinal product on pregnant or lactating cats, or on sick or debilitated cats.
Mhux applikabbli.
EU/ 2/ 06/ 064/ 003– 1 blister card of 3 pipettes of 1.60 ml EU/ 2/ 06/ 064/ 004 – 2 blister cards of 3 pipettes of 1.60 ml
EU/ 2/ 06/ 064/ 003 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 01. 60 ml EU/ 2/ 06/ 064/ 004 – Żewġ pakkett f’ folja ta ’ 3 pipetti ta ’ 1. 60 ml
FOIL 0.80 ml
FOJL 0. 80 ml
ProMeris 160 mg Spot-on for small cats {≤ 4 kg}
ProMeris 160 mg għall- Użu Lokalizzat għall- qtates żgħar {≤ 4 kg}
FOIL 1.60 ml
FOJL 1. 60 ml
16 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for small cats
Għall- qtates żgħar
17 MINIMUM PARTICULARS TO APPEAR ON PIPETTES
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PIPETTI
for large cats
Għall- qtates kbar
19 PACKAGE LEAFLET ProMeris Spot-on for cats
19 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
ProMeris 160 mg Spot-on for small cats ProMeris 320 mg Spot-on for large cats
ProMeris 160 mg għall- Użu Lokalizzat għall- qtates żgħar ProMeris 320 mg għall- Użu Lokalizzat għall- qtates kbar
Active Substance Each ml contains 200 mg metaflumizone
Kull ml fih 200 mg metaflumizone.
ProMeris for Small Cats (≤ 4 kg) ProMeris for Large Cats (> 4 kg)
ProMeris għall- Qtates Żgħar (≤ 4 kg) ProMeris għall- Qtates Kbar (> 4 kg)
0.80 1.60
0. 80 ml 1. 60 ml
160 320
160 mg 320 mg
Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Għall- kura u prevenzjoni ta ’ infestazzjonijiet mill- briegħed (Ctenocephalides canis u C. felis) fil - qtates.
Do not use in kittens under 8 weeks of age.
Tagħtix lill- frieħ ta ’ qtates taħt l- età ta ’ 8 ġimgħat.
In sick or debilitated animals use only according to the benefit/ risk assessment.
F’ annimali morda jew dgħajfa, uża biss skond l- analiżi tal- benefiċċji/ riskji.
This is not a sign of intoxication and disappears within minutes without treatment.
Dan mhux sinjal ta ’ intossikazzjoni u jgħaddi wara ftit minuti mingħajr it- trattament.
Correct application will minimise licking of the application site.
Applikazzjoni korretta tnaqqas li l- annimal jilgħaq il- post ta ’ applikazzjoni.
Cats above 8 weeks of age.
Għall- klieb b’ età ’ l fuq minn 8 ġimgħat.
The recommended minimum dose is 40 mg metaflumizone/ kg bodyweight, equivalent to 0.20ml/ kg bodyweight.
Id- doża minima rakkomandata hija ta ’ 40 mg metaflumizone/ kg piż tal- ġisem, ekwivalent għal 0. 20 ml/ kg piż tal- ġisem.
The following table defines the size of pipette to be used according to the weight of the cat.
It- tabella li ġejja tiddefinixxi id- daqs tal- pipetta li għandha tintuża skond il- piż tal- qattus.
Weight Of Cat (kg)
Piż tal- Qattus (kg)
ProMeris for Small Cats
ProMeris għall- Qtates Żgħar
ProMeris for Large Cats
ProMeris għall- Qtates Kbar
Part the fur on the cat’ s neck at the base of the skull until the skin is visible.
Ferraq il - pil fl- għonq tal- qattus fil- bażi tar- ras sakemm tidher il- ġilda.
21 Treatment schedule:
21 Skeda ta ’ trattament:
For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Għall- kontroll ottimali ta ’ infestazzjoni tal- briegħed, il- prodott mediċinali veterinarju jista ’ jingħata f’ intervalli ta ’ 4 – 6 ġimgħat tul l- istaġun tal- briegħed jew is- skeda ta ’ trattament tista ’ tiġi ibbażata fuq is- sitwazzjoni epidemjoloġika lokali.
It is important to apply the dose to an area where the animal cannot lick it off.
Huwa importanti li d- doża tiġi applikata f’ post fejn l- annimal ma jistax jilagħqu u jneħħiħ.
Do not allow animals to groom each other following treatment.
Tħallix l - annimali jnaddfu lil xulxin wara it- trattament.
Care should be taken to ensure that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/ or other animals.
Għandha tittieħed attenzjoni sabiex il- kontenut tal- pipetta jew id- doża applikata ma tiġix f’ kuntatt ma ’ l- għajnejn jew mal- ħalq tar- reċipjent u/ jew annimali oħra.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Għall- kontroll ottimali tal- problema tal- briegħed f’ dar fejn hemm aktar minn annimal wieħed, l - annimali kollha fid- dar għandhom jiġu trattati b’ insettiċida xieraq.
In addition, it is recommended to treat the environment with a suitable insecticide.
Barra minn hekk huwa rakkomandat li l- ambjent jiġi ttrattat b’ insettiċida xieraq.
If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water.
Jekk bi żball il- prodott mediċinali veterinarju jidħol fl- għajnejn, dawn għandhom jitlaħalħu sew bl- ilma.
Do not smoke, drink or eat while handling the product.
Tpejjipx, tixrobx jew tiekolx waqt li qed timmaniġġja l- prodott mediċinali veterinarju.
Children should not be allowed to play with treated animals until the application site is dry.
It- tfal m’ għandhomx jitħallew jilgħabu ma ’ annimali trattati qabel ma l- post tal- applikazzjoni jinxef.
It is therefore recommended to treat the animals during the evening and that recently treated animals are not allowed to sleep with owners, especially children.
Għalhekk huwa rakkomandat li l- annimali jiġu trattati fil- għaxija u li annimali li ġew kkurati reċentement ma jitħallewx jorqdu ma ’ sidhom, speċjalment tfal.
Carefully dispose of used pipettes immediately after use.
Armi b’ kawtela l- pipetti wżati mmedjatament wara l- użu.
7 December 2007
7 ta ’ Dicembru 2007
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 tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
Danmark ScanVet Animal Health A/ S Tlf: + 45 48 48 43 17
23 Danmark ScanVet Animal Health A/ S Tlf: + 45 48 48 43 17
Österreich Fort Dodge Veterinär Tel: + 43 (0)6245 7065316
Fort Dodge Veterinär Tel: + 43 (0) 6245 7065316
EMEA/ V/ C/ 074
EMEA/ V/ C/ 073
What is ProteqFlu-Te?
X’ inhu ProteqFlu- Te?
ProteqFlu-Te is a vaccine for use in horses.
ProteqFlu- Te huwa vaċċin għall- użu fiż- żwiemel.
It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium).
Huwa fih partijiet minn żewġ forom ta ’ influwenza (flu) taż- żwiemel, li ddaħħlu f’ żewġ vajrusijiet canarypox vector rispettivament, u tosojde (tossini mdgħajfa kimikament mill- batterju tat- tetnu).
ProteqFlu-Te is available as a suspension for injection.
ProteqFlu- Te huwa disponibbli bħala sospensjoni għall- injezzjoni.
What is ProteqFlu-Te used for?
Għalxiex jintuża ProteqFlu- Te?
ProteqFlu-Te is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
ProteqFlu- Te jintuża sabiex jitlaqqmu żwiemel ta ’ 4 xhur u aktar kontra l- influwenza taż - żwiemel u kontra t- tetnu.
The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Il- vaċċin inaqqas is- sinjali kliniċi tal- influwenza taż- żwiemel u l - eskrezzjoni (tixrid) tal- vajrus wara l- infezzjoni.
Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.
L- influwenza taż- żwiemel hija marda kontaġġjuża ħafna li hija komuni ħafna fiż- żwiemel iżda rari tikkawża mwiet.
The vaccine also stimulates protection against tetanus to prevent mortality.
Il- vaċċin jistimula wkoll il- protezzjoni kontra t- tetnu sabiex jimpedixxi l- mortalità.
Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani.
It- tetnu huwa marda akuta u spiss fatali ikkawżata min- newrotossin tal- batterju Clostridium tetani.
The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Il- marda, li normalment toriġina minn feriti kkontaminati, hija kkaratterizzata minn riġidità totali (għebusija) u spażmi konvulsivi tal- muskoli.
The muscle stiffness usually starts from the jaw and neck, then affects the whole body.
L- għebusija tal- muskoli tibda normalment mix - xedaq u mill- għonq, imbagħad taffettwa l- ġisem kollu.
Horses are among the most susceptible species to tetanus.
Iż- żwiemel huma fost l- aktar speċi suxxettibbli għat- tetnu.
The vaccine is given as an intramuscular injection (injection into a muscle).
Il- vaċċin jingħata bħala injezzjoni intramuskolari (injezzjoni ġewwa muskolu).
Horses should receive a primary vaccination, consisting of two injections at 5 - 6 months of age, given 4 - 6 weeks apart.
Iż- żwiemel għandhom jingħataw tilqima primarja, li tikkonsisti minn żewġ injezzjonijiet meta ż- żiemel ikollu 5 – 6 xhur, mogħtija 4 - 6 ġimgħat ’ il bogħod minn xulxin.
This should be followed by revaccination 5 months later, and afterwards by yearly booster vaccinations.
Din għandha tkun segwita minn tilqima mill- ġdid 5 xhur wara u suċċessivament minn tilqimiet booster kull sena.
In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).
F’ każ ta ’ riskju akbar ta ’ infezzjoni jew teħid insuffiċjenti ta ’ kolostru (l- ewwel ħalib), tista ’ tingħata injezzjoni inizjali oħra fl- età ta ’ 4 xhur, segwita mill- programm sħiħ ta ’ vaċċinazzjoni (tilqima primarja u t- tilqimiet mill- ġdid ta ’ wara).
How does ProteqFlu-Te work?
Kif jaħdem ProteqFlu- Te?
ProteqFlu-Te is a vaccine which was produced with the use of recombinant technology.
ProteqFlu- Te huwa vaċċin li ġie prodott bl- użu ta ’ teknoloġija rikombinanti.
This means that a gene from two different equine influenza strains (A/ equi-2/ Ohio/ 03 and A/ equi- 2/ Newmarket/ 2/ 93) was inserted in two live canary pox vector viruses respectively which made them capable to produce parts of these influenza strains (specific proteins).
Dan ifisser li ġene minn żewġ forom differenti ta ’ influwenza taż- żwiemel (A/ equi- 2/ Ohio/ 03 u A/ equi - 2/ Newmarket/ 2/ 93) jiddaħħal f’ żewġ vajrusijiet ħajjin tal- canary pox vector rispettivament li jagħmilhom kapaċi jipproduċu partijiet minn dawn il- forom ta ’ influwenza (proteini speċifiċi).
When ProteqFlu-Te is given to horses, the animals’ immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid as ‘ foreign ’ and makes antibodies against them.
Meta ProteqFlu- Te jingħata liż- żwiemel, is- sistema immunitarja tal- annimali tagħraf il- proteini speċifiċi mill- forom tal- influwenza taż- żwiemel u tat- tossojde tat- tetnu bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium.
Is- sistema immunitarja mbagħad tkun tista ’ tagħmel dawn l- antikorpi protettivi iżjed malajr meta l- annimal ikun espost b’ mod naturali għall- vajrusijiet tal- influwenza taż- żwiemel u għall- batterju tat- tetnu.
This will help to protect against equine influenza and tetanus.
Dan jgħin fil- protezzjoni kontra l- influwenza taż- żwiemel u t- tetnu.
The vaccine also contains an ‘ adjuvant’ to stimulate a better response.
Il- vaċċin fih ukoll ‘ adjuvanti ’ biex jistimula rispons aħjar.
How has ProteqFlu-Te been studied?
Kif ġie studjat ProteqFlu- Te?
The safety of ProteqFlu-Te was studied in several studies under laboratory and field conditions in a large number of horses, of all ages (from 1 month to 40 years) and physiological status (foals, non-pregnant and pregnant female adults and male adults).
Is- sigurtà ta ’ ProteqFlu- Te ġiet studjata f’ diversi studji taħt kundizzjonijiet tal- laboratorju u tal - kamp f’ numru kbir ta ’ żmien, ta ’ kull età (minn xahar sa 40 sena) u status fiżjoloġiku (mħor, żwiemel nisa adulti tqal u mhux tqal u żwiemel irġiel adulti).
It was concluded that the product is safe at very high doses in the target species, also in pregnant mares, whatever the stage of pregnancy.
Ġie konkluż li l- prodott huwa bla periklu b’ dożi għoljin ħafna fl- ispeċijiet fil- mira, anki fi dwieb tqal, irrispettivament mill- istadju tat- tqala.
It was also shown that, when used in the horse, the live viruses contained in the vaccine do not spread, nor disseminate, nor replicate on the place of inoculation and do not recombine with another virus.
Intwera wkoll li, meta jintuża fiż- żiemel, il- vajrusijiet ħajjin li jinstabu fil- vaċċin ma jinfirxux, jew jixterdu, jew jirreplikaw fuq il- post tal- inokulazzjoni u ma jingħaqdux ma ’ vajrus ieħor.
No environmental risk was identified through the use of this vaccine.
Ma ġie identifikat l- ebda riskju ambjentali mill- użu ta ’ dan il- vaċċin.
The effectiveness of ProteqFlu-Te was studied in several studies under laboratory and field conditions.
L- effikaċja ta ’ ProteqFlu- Te ġiet studjata f’ diversi studji taħt kundizzjonijiet tal- laboratorju u tal- kamp.
In studies under laboratory conditions, horses were challenged (infected) with equine influenza virus.
Fi studji taħt kundizzjonijiet tal- laboratorju, iż- żwiemel ġew sfidati (infettati) bil - vajrus tal- influwenza taż- żwiemel.
The clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non vaccinated animals or vaccinated with a competitive product).
Is- sinjali kliniċi u l- eskrezzjoni tal- vajrus tal- influwenza wara l- isfida tqabblu bejn annimali mlaqqma u annimali ta ’ kontroll (annimali mhux imlaqqma jew annimali mlaqqma bi prodott kompetittiv).
The production of protective levels of antibodies against the two influenza vaccine strains was measured in all studies.
Il- produzzjoni ta ’ livelli protettivi ta ’ antikorpi kontra ż- żewġ forom ta ’ vaċċin kontra l- influwenza tkejlet fl- istudji kollha.
Regarding tetanus, no challenge (infection) experiment was performed for ethical reason.
Fir- rigward tat - tetnu, ma twettaq ebda esperiment ta ’ sfida (injezzjoni) għal raġunijiet etiċi.
The measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.
Il- miżura tal - effikaċja kienet il- produzzjoni ta ’ livelli ta ’ protezzjoni ta ’ antikorpi kontra t- tossojdi tat- tetnu wara t- tilqim.
What benefit has ProteqFlu-Te shown during the studies?
Liema benefiċċju wera ProteqFlu- Te waqt l- istudji mwettqa?
The studies showed that ProteqFlu-Te is an effective vaccine in horses from 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality from 14 days after primary vaccination.
L- istudji wrew li ProteqFlu- Te huwa vaċċin effettiv fi żwiemel minn 4 xhur ’ il fuq kontra l - influwenza taż- żwiemel biex inaqqas is- sinjali kliniċi u l- eskrezzjoni tal- vajrus wara l - infezzjoni, u kontra t- tetnu sabiex jimpedixxi l- mortalità minn 14- il jum wara t- tilqima primarja.
The duration of protection was 5 months after primary vaccination and one year after the third vaccination.
It- tul tal- protezzjoni kien ta ’ 5 xhur wara t- tilqima primarja u sena wara t- tielet tilqima.
What is the risk associated with ProteqFlu-Te?
X’ inhu r- riskju assoċjat ma ’ ProteqFlu- Te?
Swelling may occur, (max. diameter 5 cm) which decreases within 4 days.
Jista ’ jkun hemm nefħa, (dijametru massimu 5 cm) li tonqos fi żmien 4 ijiem.
Pain and local hyperthermia (increase in body temperature) can occur in rare cases.
F’ każijiet rari jista ’ jkun hemm uġigħ u ipertermija lokali (żieda fit- temperatura tal- ġisem).
A slight increase in temperature (max.1.5 °C) may occur for one day, exceptionally for two days.
Jista ’ jkun hemm żieda ħafifa fit- temperatura (massimu 1. 5 °C) għal ġurnata, b’ mod eċċezzjonali għal jumejn.
In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
F’ ċirkostanzi eċċezzjonali, jistgħu jiġu osservati apatija u tnaqqis fl- aptit l- għada tat- tilqima.
Also in exceptional circumstances, a hypersensitivity (allergic) reaction can occur, which may require appropriate symptomatic treatment.
F’ każijiet eċċezzjonali wkoll, tista ’ sseħħ reazzjoni ta ’ sensittività eċċessiva (allerġika), li tista ’ tkun teħtieġ trattament sintomatiku xieraq.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Jekk aċċidentalment tinjetta lilek innifsek, fittex parir mediku minnufih u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
Page 2/ 3 ©EMEA 2008 What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Paġna 2/ 3 ©EMEA 2008 X’ inhu ż- żmien li għandu jitħalla jgħaddi qabel ma l- annimal ikun jista ’ jinqatel u l- laħam tiegħu jintuża għall- konsum uman (perjodu ta ’ twaqqif)?
The withdrawal period of the product is zero days.
Il- perjodu ta ’ tiżmin tal- prodott huwa ta ’ żero jiem.
What is the time to allow before milk can be taken from the animal for human consumption?
X’ inhu ż- żmien li għandu jitħalla jgħaddi qabel ma jkun jista ’ jittieħed ħalib mill- annimal biex jiġi kkunsmat mill- bniedem?
Zero days.
Ebda ġurnata.
Why has ProteqFlu-Te been approved?
Għaliex ġie approvat ProteqFlu- Te?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) kkonkluda li l- benefiċċji ta ’ ProteqFlu- Te huma akbar mir- riskji għall- immunizzazzjoni attiva taż- żwiemel ta ’ 4 xhur jew aktar kontra l- influwenza taż- żwiemel biex jitnaqqsu s- sinjali kliniċi u l- eskrezzjoni tal- vajrus wara l- infezzjoni, u kontra t- tetnu biex tiġi pprevenuta l- mortalità.
The Committee recommended that ProteqFlu-Te be given a marketing authorisation.
Il- Kumitat irrakkomanda li ProteqFlu- Te jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r - riskju jista ’ jinstab f’ modulu 6 ta ’ dan l- Epar.
Other information about ProteqFlu-Te:
Informazzjoni oħra dwar ProteqFlu- Te:
The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te to Merial S. A. S. on 6 March 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal ProteqFlu- Te lil Merial S. A. S. fis- 6 ta ’ Marzu 2003.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated in September 2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ Settembru 2008.
EU Number
Numru ta ’ l - Unjoni Ewropea
Tradename
Isem fis- suq
Strength
Qawwa ≥ 5. 3 log10 FAID50
Target Species
Speċi li fuqhom ser jintuża
Route of administration
Metodu ta ’ amministrazzjoni
Withdrawal period
Perijodu ta ’ tiżmim
≥ 5.3 log10 FAID50 to 7.6 log10 FAID50 for both vCP2242 and vCP1533 per dose
sa 7. 6 log10 FAID50 sia għal vCP- 2242 kemm għal vCP1533 għal kull doża ≥30 UI/ ml għat- tetnu għal kull doża
Intramuscular use
Għall- użu fil - muskolu
Suspension: vial (glass)
Suspensjoni Fjala (tal - hġieġ)
1 ml
Suspensjoni (1 ml)
0 days
xejn
ProteqFlu-Te Suspension for injection for horses
ProteqFlu- Te Suspensjoni għall- injezzjoni għaż- żwiemel.
One dose contains:
Doża waħda fiha: