ProMeris Duo

Country: European Union

Language: English

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:

Dogs

Therapeutic area:

Ectoparasiticides for topical use, incl. insecticides

Therapeutic indications:

For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs.The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Product summary:

Revision: 7

Authorization status:

Withdrawn

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. PACKAGE LEAFLET
33
Medicinal product no longer authorised
PACKAGE LEAFLET
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
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release
Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
95121 Catania
Italy
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
ACTIVE SUBSTANCES
Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Each unit dose (pipette) of ProMeris Duo delivers:
VOLUME
(ML)
METAFLUMIZONE
(MG)
AMITRAZ
(MG)
ProMeris Duo Spot-on for Small Dogs
(
≤
5 kg)*
0.67
100.5
100.5
ProMeris Duo Spot-on for Medium Sized Dogs -
(5.1 – 10.0 kg)*
1.33
199.5
199.5
ProMeris Duo Spot-on for Medium/Large Sized
Dogs (10.1 – 25.0 kg)*
3.33
499.5
499.5
ProMeris Duo Spot-on for Large Dogs
(25.1 – 40.0 kg)*
5.33
799.5
799.5
ProMeris Duo Spot-on for Extra Large Dogs
(40.1 – 50.0 kg)*
6.66
999
999
34
Medicinal product no longer authorised
*DUE TO LIMITED SPACE ON THE PACKAGING, THE ABBREVIATIONS "S", "M",
"M/L", "L" AND "XL",
WHICH REPRESENT "SMALL", “MEDIUM”,” MEDIUM/LARGE”, “LARGE”
AND “EXTRA LARGE”, RESPECTIVELY,
ARE USED ON THE BLISTER FOIL AND APPLICATOR PIPETTES.
4.
INDICATION(S)
For the treat
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Each unit dose (pipette) of ProMeris Duo delivers:
PROMERIS DUO SPOT-ON FOR DOGS
VOLUME
(ML)
METAFLUMIZONE
(MG)
AMITRAZ
(MG)
for Small Dogs (
≤
5 kg)
0.67
100.5
100.5
for Medium Sized Dogs - (5.1 – 10.0 kg)
1.33
199.5
199.5
for Medium/Large Sized Dogs (10.1 – 25.0 kg)
3.33
499.5
499.5
for Large Dogs (25.1 – 40.0 kg)
5.33
799.5
799.5
for Extra Large Dogs (40.1 – 50.0 kg)
6.66
999
999
EXCIPIENTS
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution
A clear, yellow to amber solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs over 8 weeks of age
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of infestations by fleas (
_Ctenocephalides canis and C. felis_
), and
ticks (
_Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus,
Dermacentor reticulatus and _
_Dermacentor _
_variabilis_
),
and
treatment
of
demodicosis
(caused
by
_Demodex _
spp
_._
)
and
lice
(
_Trichodectes canis_
) in dogs. The veterinary medicinal product can be used as part of a
treatment
strategy for flea allergy dermatitis (FAD).
4.3
CONTRAINDICATIONS
Do not administer to puppies under 8 weeks of age.
Do not administer to cats
Do not administer to sick or debilitated dogs or dogs suffering from
heat stress.
2
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS
Avoid contact with the eyes of the dog and avoid oral ingestion by the
dog.
The veterinary medicinal product remain
                                
                                Read the complete document

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Active ingredient metaflumizone, amitraz

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ATC code QP53AD51

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Marketed by Pfizer Limited 

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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 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
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 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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