ProMeris

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-07-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2015
Public Assessment Report Public Assessment Report (PAR)
14-07-2015

Active ingredient:

metaflumizone

Available from:

Pfizer Limited 

ATC code:

QP53AX25

INN (International Name):

metaflumizone

Therapeutic group:

Qtates

Therapeutic area:

Ektoparasitaċidali għall-użu topiku, inklużi. insettiċidi

Therapeutic indications:

Trattament u prevenzjoni ta 'infestazzjonijiet tal-briegħed (Ctenocephalides canis u C. felis) fil-qtates. Il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija ta' trattament għal dermatite tal-allerġija tal-briegħed (FAD).

Product summary:

Revision: 8

Authorization status:

Irtirat

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. FULJETT TA' TAGĦRIF FIL-PAKKETT
19
Medicinal product no longer authorised
FULJETT TA’ TAGĦRIF FIL-PAKKETT
PROMERIS GĦALL-UŻU LOKALIZZAT GĦALL-QTATES
1
L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ, U L-
ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-MANIFATTURA
RESPONSABBLI LI JĦALLI L-KONSENJA TMUR FIS-SUQ , JEKK DIFFERENTI
Sid l-Awtorizzazzjoni tal-Kummerċ :
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manifattur li jħalli l-konsenja tmur fis-suq:
Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
95121 Catania
L-Italja
2.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
ProMeris 160 mg għall-Użu Lokalizzat għall-qtates żgħar
ProMeris 320 mg għall-Użu Lokalizzat għall-qtates kbar
3
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) U INGREDJENT(I) OĦRA
SUSTANZI ATTIVI :
Kull ml fih 200 mg metaflumizone.
Kull unità ta’ doża (pipetta) ta’ ProMeris tagħti:
Volum (ml)
Metaflumizone (mg)
ProMeris għall-Qtates Żgħar (≤ 4
kg)*
0.80 ml
160 mg
ProMeris għall-Qtates Kbar (> 4 kg)*
1.60 ml
320 mg
*MINĦABBA NUQQAS TA’ SPAZJU, L-ABBREVJAZZJONIJIET “S” U
“L”, LI JIRRAPPREŻENTAW “ŻGĦIR” U
“KBIR” RISPETTIVAMENT, HUMA UŻATI FUQ L-ISTRIXXI U L-PIPETTI
TAL-APPLIKAZZJONI.
4
INDIKAZZJONI (JIET)
Għall-kura u prevenzjoni ta’ infestazzjonijiet mill-briegħed (
_Ctenocephalides canis u C. felis_
) fil-
qtates. Il-prodott mediċinali veterinarju jista’ jintuża bħala
parti minn strateġija ta’ kura għal dermatite
allerġika tal-bergħud (FAD).
20
Medicinal product no longer authorised
5
KUNTRADIZZJONIJIET
Tagħtix lill-frieħ ta’ qtates taħt l-età ta’ 8 ġimgħat.
F’annimali morda jew dgħajjfa, uża biss skond l-analiżi
tal-benefiċċji/riskji.
6.
EFFETTI MHUX MIXTIEQA*
Tista’ sseħħ ipersalivazzjoni jekk l-annimal jilgħaq il-post
ta’ l-applikazzjoni eżatt wara l-kura. Dan
mhux sinjal ta’ intossikazzjoni u jgħaddi wara ftit minuti
mingħajr kura. Applikazzjoni korretta
tnaqqas li l-annimal ji
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
_ _
ANNESS I
KARATTERISTIĊI TAL-PRODOTT FIL-QOSOR
1
Medicinal product no longer authorised
1.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
ProMeris 160 mg soluzzjoni għall-Użu Lokalizzat għall-qtates
żgħar
ProMeris 320 mg soluzzjoni għall-Użu Lokalizzat għall-qtates kbar
2.
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
SUSTANZI ATTIVI :
Kull ml fih 200 mg metaflumizone.
Kull unità ta’ doża (pipetta) ta’ ProMeris tagħti:
VOLUM (ML)
METAFLUMIZONE (MG)
ProMeris għall-Qtates Żgħar (≤ 4 kg)
0.80 ml
160 mg
ProMeris għall-Qtates Kbar (> 4 kg)
1.60 ml
320 mg
SUSTANZI MHUX ATTIVI:
Għal-lista sħiħa ta’ l-ingredjenti (mhux attivi), ara s-sezzjoni
6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-Użu Lokalizzat
Soluzzjoni ċara, safra sa amber
4
TAGĦRIF KLINIKU
4.1
SPEĊI LI FUQHOM SER JINTUŻA L-PRODOTT
Qtates b’età ’l fuq minn 8 ġimgħat
4.2
INDIKAZZJONIJIET GĦAL UŻU TAL-PRODOTT LI JISPEĊIFIKAW L-ISPEĊI LI
FUQHOM SE JINTUŻA L-PRODOTT.
Għall-kura u prevenzjoni ta’ infestazzjonijiet minn briegħed (
_Ctenocephalides canis u C. felis_
) fil-
qtates. Il-prodott mediċinali veterinarju jista’ jintuża bħala
parti minn strateġija ta’ kura għal dermatite
allerġika tal-bergħud (FAD).
4.3
KONTRA INDIKAZZJONIJIET
Tagħtix lill-frieħ ta’ qtates taħt l-età ta’ 8 ġimgħat.
4.4
TWISSIJIET SPEĊJALI
Evita l-kuntatt ma’ l-għajnejn tal-qattus u evita inġestjoni orali
mill-annimal.
2
Medicinal product no longer authorised
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. Barra
minn hekk huwa rakkomandat li l-
ambjent jiġi ttrattat b’insettiċida xieraq.
4.5
PREKAWZJONIJIET SPEĊJALI GĦALL-UŻU
Prekawzjonijiet speċjali għall-użu fl-annimali
F’annimali
morda
jew
dgħajjfa,
uża
biss
skond
l-analiżi
tal-veterinarju
responsabbli
tal-
benefiċċji/riskji.
Dan il-prodott mediċinali veterinarju huwa għall-użu lokalizzat
bi
                                
                                Read the complete document

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Patient Information leaflet Patient Information leaflet Bulgarian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2015
Public Assessment Report Public Assessment Report Bulgarian 14-07-2015
Patient Information leaflet Patient Information leaflet Spanish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2015
Public Assessment Report Public Assessment Report Spanish 14-07-2015
Patient Information leaflet Patient Information leaflet Czech 13-07-2015
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2015
Public Assessment Report Public Assessment Report Czech 14-07-2015
Patient Information leaflet Patient Information leaflet Danish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2015
Public Assessment Report Public Assessment Report Danish 14-07-2015
Patient Information leaflet Patient Information leaflet German 13-07-2015
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Public Assessment Report Public Assessment Report German 14-07-2015
Patient Information leaflet Patient Information leaflet Estonian 13-07-2015
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Public Assessment Report Public Assessment Report Estonian 14-07-2015
Patient Information leaflet Patient Information leaflet Greek 13-07-2015
Summary of Product characteristics Summary of Product characteristics Greek 13-07-2015
Public Assessment Report Public Assessment Report Greek 14-07-2015
Patient Information leaflet Patient Information leaflet English 13-07-2015
Summary of Product characteristics Summary of Product characteristics English 13-07-2015
Public Assessment Report Public Assessment Report English 14-07-2015
Patient Information leaflet Patient Information leaflet French 13-07-2015
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Public Assessment Report Public Assessment Report French 14-07-2015
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