DOLPAC 25
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
04-03-2012
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Active ingredient:
oxantel embonate 500.7 mg, praziquantel 125 mg, pyrantel embonate 124.85 mg
Available from:
Vetoquinol
ATC code:
QP52AA51
Pharmaceutical form:
Tablet
Therapeutic group:
praziquantel, combinations
Therapeutic area:
Dogs
Authorization date:
2011-05-19
Summary of Product characteristics
VETOQUINOL/DOLPAC LARGE DOGS/ EUROPEAN RENEWAL
JUNE 2011
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Austria
Belgium
Cyprus
Malta
Czech Republic
Netherlands
Greece
Portugal
Slovakia
Hungary
Slovenia
Germany
Finland
Dolpac large dogs tablets
France Luxembourg
Dolpac 25 comprimé
UK-Ireland-Italy
Dolpac Tablets for Large Dogs
Poland Spain
Dolpac large dogs tablets for 20-75
kg
Denmark
Sweden
Dolpac vet large dogs tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
Active substances
Oxantel
500.70 mg (equivalent to 1397.5 mg of oxantel
embonate)
Pyrantel
124.85 mg (equivalent to 360 mg of pyrantel embonate)
Praziquantel
125.00 mg
Excipient to one 2375 mg divisible tablet
Excipients
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Pale yellow to yellow oblong tablet with breaking line.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For curative treatment of dogs harbouring mixed parasitic infestations with t he following adult stages
of nematode and cestode species:
Nematodes:
_ _
_ _
_Toxocara canis_
_ _
_ _
_Toxascaris leonina _
_ _
_ _
_Ancylostoma caninum_
_ _
_ _
_Uncinaria stenocephala _
_ _
_ _
_Trichuris vulpis_
VETOQUINOL/DOLPAC LARGE DOGS/ EUROPEAN RENEWAL
JUNE 2011
2/5
Cestodes:
_ _
_ _
_Dipylidium caninum _
_ _
_ _
_Taenia _spp
_ _
_ _
_Echinococcus multilocularis_
_ _
_ _
_Echinococcus granulosus_
4.3
CONTRAINDICATIONS
See section 4.8
4.
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