ProMeris Duo

Country: European Union

Language: Icelandic

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

Active ingredient:

metaflumizone, amitraz

Available from:

Pfizer Limited 

ATC code:

QP53AD51

INN (International Name):

metaflumizone, amitraz

Therapeutic group:

Hundar

Therapeutic area:

Ectoparasiticides fyrir baugi nota, meðtalin. skordýraeitur

Therapeutic indications:

Til meðhöndlunar og forvarnar gegn áföllum með flórum (Ctenocephalides canis og C. sus), og ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus og Dermacentor variabilis), og meðferð demodicosis (af völdum Demodex spp. ) og lús (Trichodectes canis) hjá hundum. Dýralyfið er hægt að nota sem hluti af meðferðaráætlun fyrir húðsjúkdóm í húðflóa (FAD).

Product summary:

Revision: 7

Authorization status:

Aftakað

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. FYLGISEÐILL
33
Medicinal product no longer authorised
FYLGISEÐILL
ProMeris Duo 100,5 mg + 100,5 mg blettunarlausn handa litlum hundum.
ProMeris Duo 199,5 mg + 199,5 mg blettunarlausn handa meðalstórum
hundum.
ProMeris Duo 499,5 mg + 499,5 mg blettunarlausn handa
meðalstórum/stórum hundum.
ProMeris Duo 799,5 mg + 799,5 mg blettunarlausn handa stórum hundum.
ProMeris Duo 999 mg + 999 mg blettunarlausn handa mjög stórum
hundum.
1.
HEITI OG HEIMILISFANG HANDHAFA MARKAÐSLEYFIS OG ÞESS
FRAMLEIÐANDA SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
Bretlandi
Framleiðandi sem sér um lokasamþykkt
Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
95121 Catania
Ítalía
2.
HEITI DÝRALYFS
ProMeris Duo 100,5 mg + 100,5 mg blettunarlausn handa litlum hundum.
ProMeris Duo 199,5 mg + 199,5 mg blettunarlausn handa meðalstórum
hundum.
ProMeris Duo 499,5 mg + 499,5 mg blettunarlausn handa
meðalstórum/stórum hundum.
ProMeris Duo 799,5 mg + 799,5 mg blettunarlausn handa stórum hundum.
ProMeris Duo 999 mg + 999 mg blettunarlausn handa mjög stórum
hundum.
3.
VIRKT INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
VIRKT INNIHALDSEFNI:
Hver ml inniheldur metaflumizon 150 mg og amitraz 150 mg.
Úr hverjum stakskammti (pípettu) af ProMeris Duo fæst:
PROMERIS DUO BLETTUNARLAUSN HANDA
RÚMMÁL
(ML)
METAFLUMIZON
(MG)
AMITRAZ
(MG)
litlum hundum (≤ 5 kg)*
0,67
100,5
100,5
meðalstórum hundum (5,1-10,0 kg)*
1,33
199,5
199,5
meðalstórum/stórum hundum (10,1-25,0 kg)*
3,33
499,5
499,5
stórum hundum (25,1-40,0 kg)*
5,33
799,5
799,5
mjög stórum hundum (40,1-50,0 kg)*
6,66
999
999
*VEGNA TAKMARKAÐS PLÁSS Á PAKKNINGUNUM ERU SKAMMSTAFANIRNAR
„S“, „M“, „M/L“, „L“ OG
„XL“, SEM STANDA FYRIR „SMALL“ (LITLIR), „MEDIUM“
(MEÐALSTÓRIR), „MEDIUM/LARGE“
(MEÐALSTÓRIR/STÓRIR), „LARGE“ (STÓRIR) OG „EXTRA LARGE“
(MJÖG STÓRIR), NOTAÐAR Á ÞYNNUM OG
PÍPETTUM.
34
Medicinal product no lon
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
1
Medicinal product no longer authorised
1.
HEITI DÝRALYFS
ProMeris Duo 100,5 mg + 100,5 mg blettunarlausn handa litlum hundum.
ProMeris Duo 199,5 mg + 199,5 mg blettunarlausn handa meðalstórum
hundum.
ProMeris Duo 499,5 mg + 499,5 mg blettunarlausn handa
meðalstórum/stórum hundum.
ProMeris Duo 799,5 mg + 799,5 mg blettunarlausn handa stórum hundum.
ProMeris Duo 999 mg + 999 mg blettunarlausn handa mjög stórum
hundum.
2.
VIRK INNIHALDSEFNI OG STYRKLEIKAR
VIRKT INNIHALDSEFNI:
Hver ml inniheldur metaflumizon 150 mg og amitraz 150 mg.
Úr hverjum stakskammti (pípettu) af ProMeris Duo fæst:
PROMERIS DUO BLETTUNARLAUSN HANDA
RÚMMÁL
(ML)
METAFLUMIZON
(MG)
AMITRAZ
(MG)
litlum hundun (≤ 5 kg)
0,67
100,5
100,5
meðalstórum hundum (5,1-10,0 kg)
1,33
199,5
199,5
meðalstórum/stórum hundum (10,1-25,0 kg)
3,33
499,5
499,5
stórum hundum (25,1-40,0 kg)
5,33
799,5
799,5
mjög stórum hundum (40,1-50,0 kg)
6,66
999
999
HJÁLPAREFNI:
Heildarlisti með hjálparefnum, sjá kafla 6.1.
3.
LYFJAFORM
Blettunarlausn.
Tær, gul til gulbrún lausn.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUND(IR)
Hundar, eldri en 8 vikna.
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til meðferðar og fyrirbyggjandi meðferðar við flóarsmiti (
_Ctenocephalides canis og C. felis_
) og
blóðmítlum (
_Ixodes ricinus, Ixodes hexagonus_
,
_Rhipicephalus sanguineus,_
_Dermacentor reticulatus_
_og _
_Dermacentor variabilis_
) og til meðferðar við hársekkjamaurakláða (af völdum
_Demodex _
spp
_._
) og
feldlús (
_Trichodectes canis_
) hjá hundum. Dýralyfið má nota sem lið í meðferðaráætlun
gegn
ofnæmishúðbólgu vegna flóar.
4.3
FRÁBENDINGAR
Ekki má nota dýralyfið handa hvolpum sem eru yngri en 8 vikna.
Ekki má nota dýralyfið handa köttum.
Ekki má nota dýralyfið handa veikum eða veikluðum hundum eða
hundum sem eru undir hitaálagi.
2
Medicinal product no longer authorised
4.4
SÉRSTÖK VARNAÐARORÐ
Forðist að dýralyfið ko
                                
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Active ingredient metaflumizone, amitraz

metaflumizone, amitraz

ATC code QP53AD51

QP53AD51

Marketed by Pfizer Limited 

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INN (International Name) metaflumizone, amitraz

metaflumizone, amitraz

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