Profender
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
25-01-2021
Produktets egenskaber
(SPC)
25-01-2021
Offentlige vurderingsrapport
(PAR)
06-06-2016
Aktiv bestanddel:
emodepside, praziquantel
Tilgængelig fra:
Vetoquinol S.A.
ATC-kode:
QP52AA51
INN (International Name):
emodepside, praziquantel
Terapeutisk gruppe:
Dogs; Cats
Terapeutisk område:
Antiparasitic products, insecticides and repellents
Terapeutiske indikationer:
CatsFor cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (Nematodes)Toxocara cati (mature adult, immature adult, L4 and L3);Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring;Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma tubaeforme (mature adult, immature adult and L4).Tapeworms (Cestodes)Dipylidium caninum (mature adult and immature adult);Taenia taeniaeformis (adult);Echinococcus multilocularis (adult).LungwormsAelurostrongylus abstrusus (adult).DogsFor dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (nematodes):Toxocara canis (mature adult, immature adult, L4 and L3);Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma caninum (mature adult and immature adult);Uncinaria stenocephala (mature adult and immature adult);Trichuris vulpis (mature adult, immature adult and L4);Tapeworms (Cestodes):Dipylidium caninum;Taenia spp.;Echinococcus multilocularis (mature adult and immature);Echinococcus granulosus (mature adult and immature).
Produkt oversigt:
Revision: 19
Autorisation status:
Authorised
Autorisation dato:
2005-07-27
Indlægsseddel
63
B. PACKAGE LEAFLET
64
[Single-dose pipettes]
PACKAGE LEAFLET
PROFENDER 30 MG / 7.5 MG SPOT-ON SOLUTION FOR SMALL CATS
PROFENDER 60 MG / 15 MG SPOT-ON SOLUTION FOR MEDIUM CATS
PROFENDER 96 MG / 24 MG SPOT-ON SOLUTION FOR LARGE CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
France
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Profender 30 mg / 7.5 mg spot-on solution for small cats
Profender 60 mg / 15 mg spot-on solution for medium cats
Profender 96 mg / 24 mg spot-on solution for large cats
Praziquantel / Emodepside
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
ACTIVE SUBSTANCES:
Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.
Each unit dose (pipette) of Profender contains:
VOLUME
EMODEPSIDE
PRAZIQUANTEL
Profender for Small Cats
(
0.5 - 2.5 kg)
0.35 ml
7.5 mg
30 mg
Profender for Medium Cats
(> 2.5 – 5 kg)
0.70 ml
15 mg
60 mg
Profender for Large Cats
(> 5 – 8 kg)
1.12 ml
24 mg
96 mg
EXCIPIENTS:
5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
65
4.
INDICATIONS
For cats suffering from, or at risk from, mixed parasitic infections
caused by roundworms, tapeworms
and lungworms of the following species:
Roundworms (Nematodes)
_Toxocara cati_ (mature adult, immature adult, L4 and L3)
_Toxocara cati_ (L3 larvae) – treatment of queens during late
pregnancy to prevent lactogenic
transmission to the offspring
_Toxascaris leonina_ (mature adult, immature adult and L4)
_Ancylostoma tubaeforme_ (mature adult, immature adult and L4)
Tapeworms (Cestodes)
_Dipylidium caninum_ (mature adult and immature adult)
_Taenia taeniaeformis_ (adult)
_Echinococcus multilocularis_ (adult)
Lungworms
_Aelurostrongylus abstrusus_ (adult)
5.
CONTRAINDICATIONS
Do not use in kittens under 8 weeks of
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
[Single-dose pipettes]
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Profender 30 mg/7.5 mg spot-on solution for small cats
Profender 60 mg/15 mg spot-on solution for medium cats
Profender 96 mg/24 mg spot-on solution for large cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.
Each unit dose (pipette) of Profender contains:
VOLUME
EMODEPSIDE
PRAZIQUANTEL
Profender for Small Cats
(
0.5 - 2.5 kg)
0.35 ml
7.5 mg
30 mg
Profender for Medium Cats
(> 2.5 – 5 kg)
0.70 ml
15 mg
60 mg
Profender for Large Cats
(> 5 – 8 kg)
1.12 ml
24 mg
96 mg
EXCIPIENTS:
5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow to brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For cats suffering from, or at risk from, mixed parasitic infections
caused by roundworms, tapeworms
and lungworms of the following species:
Roundworms (Nematodes)
_Toxocara cati_ (mature adult, immature adult, L4 and L3)
_Toxocara cati_ (L3 larvae) – treatment of queens during late
pregnancy to prevent lactogenic
transmission to the offspring_ _
_Toxascaris leonina_ (mature adult, immature adult and L4)
3
_Ancylostoma tubaeforme_ (mature adult, immature adult and L4)
Tapeworms (Cestodes)
_Dipylidium caninum_ (mature adult and immature adult)
_Taenia taeniaeformis_ (adult)
_Echinococcus multilocularis_ (adult)
Lungworms
_Aelurostrongylus abstrusus_ (adult)
4.3
CONTRAINDICATIONS
Do not use in kittens under 8 weeks of age or weighing less than 0.5
kg.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Shampooing or immersion of the animal in water directly after
treatment may reduce the efficacy of
the product. Treated animals therefore should not be bathed until the
solutio
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