ProMeris Duo

Country: European Union

Language: Spanish

Source: EMA (European Medicines Agency)

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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, amitraz

Available from:

Pfizer Limited 

ATC code:

QP53AD51

INN (International Name):

metaflumizone, amitraz

Therapeutic group:

Perros

Therapeutic area:

Ectoparasiticides para uso tópico, incl. los insecticidas

Therapeutic indications:

Para el tratamiento y prevención de infestaciones por pulgas (Ctenocephalides canis y C. felis) y garrapatas (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus y Dermacentor variabilis), y el tratamiento de la infección (causada por Demodex spp. ) y piojos (Trichodectes canis) en perros. El medicamento veterinario se puede utilizar como parte de una estrategia de tratamiento para la dermatitis alérgica a las pulgas (FAD).

Product summary:

Revision: 7

Authorization status:

Retirado

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. PROSPECTO
38
Medicinal product no longer authorised
PROSPECTO
ProMeris Duo 100,5 mg + 100,5 mg Spot-on para perros pequeños
ProMeris Duo 199,5 mg + 199,5 mg Spot-on para perros medianos
ProMeris Duo 499,5 mg + 499,5 mg Spot-on para perros medianos/grandes
ProMeris Duo 799,5 mg + 799,5 mg Spot-on para perros grandes
ProMeris Duo 999 mg + 999 mg Spot-on para perros muy grandes
1.
NOMBRE O RAZÓN SOCIAL Y DOMICILIO O SEDE SOCIAL DEL TITULAR DE
LA AUTORIZACIÓN DE COMERCIALIZACIÓN Y DEL FABRICANTE
RESPONSABLE DE LA LIBERACIÓN DE LOS LOTES, EN CASO DE QUE SEAN
DIFERENTES
Titular de la autorización de comercialización
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
Reino Unido
Fabricante que libera el lote
Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
95121 Catania
Italia
2.
DENOMINACIÓN DEL MEDICAMENTO VETERINARIO
ProMeris Duo 100,5 mg + 100,5 mg Spot-on para perros pequeños
ProMeris Duo 199,5 mg + 199,5 mg Spot-on para perros medianos
ProMeris Duo 499,5 mg + 499,5 mg Spot-on para perros medianos/grandes
ProMeris Duo 799,5 mg + 799,5 mg Spot-on para perros grandes
ProMeris Duo 999 mg + 999 mg Spot-on para perros muy grandes
3.
COMPOSICIÓN CUALITATIVA Y CUANTITTATIVA DE LAS SUSTANCIAS
ACTIVAS Y OTRAS SUSTANCIAS
SUSTANCIAS ACTIVAS
Cada ml contiene 150 mg de metaflumizona y 150 mg de amitraz.
Cada dosis (pipeta) de ProMeris Duo contiene:
PROMERIS DUO SPOT-ON
VOLUMEN
(ML)
METAFLUMIZONA
(MG)
AMITRAZ
(MG)
para perros pequeños (
≤
5 kg)*
0,67
100,5
100,5
para perros medianos (5,1 – 10,0 kg)*
1,33
199,5
199,5
para perros medianos/grandes (10,1 – 25,0 kg)*
3,33
499,5
499,5
para perros grandes (25,1 – 40,0 kg)*
5,33
799,5
799,5
para perros muy grandes (40,1 – 50,0 kg)*
6,66
999
999
39
Medicinal product no longer authorised
* DEBIDO AL ESPACIO REDUCIDO EN LOS BLISTERES Y PIPETAS, SE UTILIZAN
LAS ABREVIATURAS “S”, “M”,
“M/L”, “L” Y “XL” PARA INDICAR “PEQUEÑO”,
“MEDIANO”, “MEDIANO/GRANDE”, “GRANDE” Y “MUY
GRANDE”, RESPECT
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ANEXO I
FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
1
Medicinal product no longer authorised
1.
DENOMINACIÓN DEL MEDICAMENTO VETERINARIO
ProMeris Duo 100,5 mg + 100,5 mg Spot-on para perros pequeños
ProMeris Duo 199,5 mg + 199,5 mg Spot-on para perros medianos
ProMeris Duo 499,5 mg + 499,5 mg Spot-on para perros medianos/grandes
ProMeris Duo 799,5 mg + 799,5 mg Spot-on para perros grandes
ProMeris Duo 999 mg + 999 mg Spot-on para perros muy grandes
2.
COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
SUSTANCIAS ACTIVAS :
Cada ml contiene 150 mg de metaflumizona y 150 mg de amitraz.
Cada dosis (pipeta) de ProMeris Duo contiene:
PROMERIS DUO SPOT-ON PARA PERROS
VOLUMEN
(ML)
METAFLUMIZONA
(MG)
AMITRAZ
(MG)
para perros pequeños (≤ 5 kg)
0,67
100,5
100,5
para perros medianos (5,1 – 10,0 kg)
1,33
199,5
199,5
para perros medianos/grandes (10,1 – 25,0 kg)
3,33
499,5
499,5
para perros grandes (25,1 – 40,0 kg)
5,33
799,5
799,5
para perros muy grandes (40,1 – 50,0 kg)
6,66
999
999
EXCIPIENTES
:
Para la lista completa de excipientes, véase la sección 6.1.
3.
FORMA FARMACÉUTICA
Solución para unción dorsal puntual
Solución transparente de color amarillo-ámbar.
4.
DATOS CLÍNICOS
4.1
ESPECIES DE DESTINO
Perros a partir de las 8 semanas.
4.2
INDICACIONES DE USO, ESPECIFICANDO LAS ESPECIES DE DESTINO
Tratamiento y prevención de las infestaciones por pulgas (
_Ctenocephalides canis y C. felis_
) y
garrapatas (
_Ixodes ricinus, Ixodes hexagonus_
,
_Rhipicephalus sanguineus_
,
_Dermacentor reticulatus _
_and Dermacentor variabilis_
)
y tratamiento de la sarna demodécica (causada por
_Demodex_
spp.) y
piojos (
_Trichodectes canis_
) en perros
.
El medicamento veterinario puede utilizarse como parte del
tratamiento estratégico de la dematitis alérgica a pulgas (DAP).
4.3
CONTRAINDICACIONES
No administrar a cachorros de menos de 8 semanas.
No administrar a gatos.
No administrar a perros enfermos o debilitados, o a perros que sufran
un golpe de calor.
2
Medicinal pro
                                
                                Read the complete document

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Active ingredient metaflumizone, amitraz

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INN (International Name) metaflumizone, amitraz

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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 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
Summary of Product characteristics Summary of Product characteristics German 13-07-2015
Public Assessment Report Public Assessment Report German 14-07-2015
Patient Information leaflet Patient Information leaflet Estonian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Estonian 13-07-2015
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
Summary of Product characteristics Summary of Product characteristics French 13-07-2015
Public Assessment Report Public Assessment Report French 14-07-2015
Patient Information leaflet Patient Information leaflet Italian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Italian 13-07-2015
Public Assessment Report Public Assessment Report Italian 14-07-2015
Patient Information leaflet Patient Information leaflet Latvian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Latvian 13-07-2015
Public Assessment Report Public Assessment Report Latvian 14-07-2015
Patient Information leaflet Patient Information leaflet Lithuanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-07-2015
Public Assessment Report Public Assessment Report Lithuanian 14-07-2015
Patient Information leaflet Patient Information leaflet Hungarian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Hungarian 13-07-2015
Public Assessment Report Public Assessment Report Hungarian 14-07-2015
Patient Information leaflet Patient Information leaflet Maltese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Maltese 13-07-2015
Public Assessment Report Public Assessment Report Maltese 14-07-2015
Patient Information leaflet Patient Information leaflet Dutch 13-07-2015
Summary of Product characteristics Summary of Product characteristics Dutch 13-07-2015
Public Assessment Report Public Assessment Report Dutch 14-07-2015
Patient Information leaflet Patient Information leaflet Polish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Polish 13-07-2015
Public Assessment Report Public Assessment Report Polish 14-07-2015
Patient Information leaflet Patient Information leaflet Portuguese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Portuguese 13-07-2015
Public Assessment Report Public Assessment Report Portuguese 14-07-2015
Patient Information leaflet Patient Information leaflet Romanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Romanian 13-07-2015
Public Assessment Report Public Assessment Report Romanian 14-07-2015
Patient Information leaflet Patient Information leaflet Slovak 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovak 13-07-2015
Public Assessment Report Public Assessment Report Slovak 14-07-2015
Patient Information leaflet Patient Information leaflet Slovenian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 13-07-2015
Public Assessment Report Public Assessment Report Slovenian 14-07-2015
Patient Information leaflet Patient Information leaflet Finnish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Finnish 13-07-2015
Public Assessment Report Public Assessment Report Finnish 14-07-2015
Patient Information leaflet Patient Information leaflet Swedish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Swedish 13-07-2015
Public Assessment Report Public Assessment Report Swedish 14-07-2015
Patient Information leaflet Patient Information leaflet Norwegian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Norwegian 13-07-2015
Patient Information leaflet Patient Information leaflet Icelandic 13-07-2015
Summary of Product characteristics Summary of Product characteristics Icelandic 13-07-2015

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ProMeris Duo