Trifexis

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Active ingredient:

spinosad, milbemiċin oxime

Available from:

Eli Lilly and Company Limited

ATC code:

QP54AB51

INN (International Name):

spinosad, milbemycin oxime

Therapeutic group:

Klieb

Therapeutic area:

Prodotti kontra l-parassiti, insettiċidi u sustanzi, Endectocides

Therapeutic indications:

Għat-trattament u l-prevenzjoni tal-briegħed (Ctenocephalides felis) jigdem fil-klieb fejn wieħed jew aktar ta 'l-indikazzjonijiet li ġejjin huma meħtieġa fl-istess ħin: il-prevenzjoni tal-heartworm disease (L3, L4-Dirofilaria immitis);il-prevenzjoni tal-angiostrongylosis billi tnaqqas il-livell ta' l-infezzjoni bil-adulti immaturi (L5) ' Angiostrogylus vasorum;it-trattament ta'gastro-nematodu infezzjonijiet ikkawżati mill għall (L4, adulti immaturi, L5) u adulti Ancylostoma caninum), fl-imsaren (adulti immaturi L5, u l-adulti Toxocara canis u adulti Toxascaris leonina) u ħniex (adulti Trichuris vulpis).

Product summary:

Revision: 4

Authorization status:

Irtirat

Authorization date:

2013-09-19

Patient Information leaflet

                                Prodott mediċinali li m’għadux awtorizzat
19
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
20
FULJETT TA’ TAGĦRIF GĦAL:
TRIFEXIS 270 MG/4.5 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
TRIFEXIS 425 MG/7.1 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
TRIFEXIS 665 MG/11.1 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
TRIFEXIS 1040 MG/17.4 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
TRIFEXIS 1620 MG/27 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
1.
L-ISEM U L-INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-
TQEGĦID FIS-SUQ U TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦALL-
MANIFATTURA RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT, JEKK DIFFERENTI
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq
Eli Lilly and Company Ltd
Elanco Animal Health
Priestley Road
Basingstoke
Hampshire
RG24 9NL
IR-RENJU UNIT
Manifattur responsabbli għall-ħruġ tal-lott:
Eli Lilly and Company Ltd
Speke Operations
Fleming Road
Liverpool
L24 9LN
IR-RENJU UNIT
2.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Trifexis 270 mg/4.5 mg pilloli li jintmagħdu għall-klieb (3.9 –
6.0 kg)
Trifexis 425 mg/7.1 mg pilloli li jintmagħdu għall-klieb (6.1 –
9.4 kg)
Trifexis 665 mg/11.1 mg pilloli li jintmagħdu għall-klieb (9.5 –
14.7 kg)
Trifexis 1040 mg/17.4 mg pilloli li jintmagħdu għall-klieb (14.8 –
23.1 kg)
Trifexis 1620 mg/27 mg pilloli li jintmagħdu għall-klieb(23.2 –
36.0 kg)
spinosad / milbemycin oxime
3.
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) U INGREDJENT(I) OĦRA
SUSTANZI ATTIVI:
Kull pillola fiha:
Trifexis 270 mg/4.5 mg
spinosad 270 mg/milbemycin oxime 4.5 mg
Trifexis 425 mg/7.1 mg
spinosad 425 mg/milbemycin oxime 7.1 mg
Trifexis 665 mg/11.1 mg
spinosad 665 mg/milbemycin oxime 11.1 mg
Trifexis 1040 mg/17.4 mg
spinosad 1040 mg/milbemycin oxime 17.4 mg
Trifexis 1620 mg/27 mg
spinosad 1620 mg/milbemycin oxime 27.0 mg
Il-pilloli huma mżewqa bi dbabar minn kannella ċar sa kannella, u
huma tondi u jistgħu jintmagħdu.
Il-lista li ġejja tipprovdi l-kodiċi u n-numru ta’ ħofor żgħar
immarkati fuq kull qawwa ta’ pillola:
Trifexis 270 mg/4
                                
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Summary of Product characteristics

                                Prodott mediċinali li m’għadux awtorizzat
1
ANNESS I
KARATTERISTIĊI TAL-PRODOTT FIL-QOSOR
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Trifexis 270 mg/4.5 mg pilloli li jintmagħdu għall-klieb (3.9 –
6.0 kg)
Trifexis 425 mg/7.1 mg pilloli li jintmagħdu għall-klieb (6.1 –
9.4 kg)
Trifexis 665 mg/11.1 mg pilloli li jintmagħdu għall-klieb (9.5 –
14.7 kg)
Trifexis 1040 mg/17.4 mg pilloli li jintmagħdu għall-klieb (14.8 –
23.1 kg)
Trifexis 1620 mg/27 mg pilloli li jintmagħdu għall-klieb (23.2 –
36.0 kg)
2.
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
SUSTANZI ATTIVI:
Kull pillola fiha:
Spinosad
Milbemycin oxime
Trifexis 270 mg/4.5 mg
270 mg
4.5 mg
Trifexis 425 mg/7.1 mg
425 mg
7.1 mg
Trifexis 665 mg/11.1 mg
665 mg
11.1 mg
Trifexis 1040 mg/17.4 mg
1040 mg
17.4 mg
Trifexis 1620 mg/27 mg
1620 mg
27.0 mg
Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pilloli li jintmagħdu.
Pilloli mżewqa bi dbabar minn kannella ċar sa kannella, tondi,
bikonvessi, b’kodiċi mnaqqxa fuq naħa
waħda u ħofor żgħar fuq in-naħa l-oħra.
Il-lista li ġejja tipprovdi l-kodiċi u n-numru ta’ ħofor żgħar
immarkati fuq kull qawwa ta’ pillola:
Trifexis 270 mg/4.5 mg pilloli:
4333 u 2 ħofor żgħar
Trifexis 425 mg/7.1 mg pilloli:
4346 u 3 ħofor żgħar
Trifexis 665 mg/11.1 mg pilloli:
4347 u l-ebda ħofor żgħar
Trifexis 1040 mg/17.4 mg pilloli:
4349 u 4 ħofor żgħar
Trifexis 1620 mg/27 mg pilloli:
4336 u 5 ħofor żgħar
4.
TAGĦRIF KLINIKU
4.1
SPEĊI LI FUQHOM SER JINTUŻA L-PRODOTT
Klieb.
4.2
INDIKAZZJONIJIET GĦAL UŻU TAL-PRODOTT LI JISPEĊIFIKAW L-ISPEĊI LI
FUQHOM SE JINTUŻA L-PRODOTT.
Għall-kura u
l-prevenzjoni ta’ infestazzjonijiet bil-briegħed (
_Ctenocephalides felis_
) fil-klieb, fejn
infezzjoni waħda jew aktar mill-indikazzjonijiet li ġejjin ikunu
meħtieġa fl-istess ħin:
-
prevenzjoni ta’ marda tal-lungworm (L3, L4
_Dirofilaria immitis_
),
-
prevenzjoni ta’ anġjostrongilożi bit-tnaqqi
                                
                                Read the complete document
                                
                            

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Patient Information leaflet Patient Information leaflet Bulgarian 08-10-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-10-2018
Public Assessment Report Public Assessment Report Bulgarian 08-10-2018
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Public Assessment Report Public Assessment Report Slovenian 08-10-2018
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Public Assessment Report Public Assessment Report Croatian 08-10-2018

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