DV8WORM 50 mg/144 mg/200 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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DSU DSU (DSU)
17-08-2022

Active ingredient:

Praziquantel; Pyrantel embonate ; Fenbendazole

Available from:

Duggan Veterinary Supplies Limited

ATC code:

QP52AA51

INN (International Name):

Praziquantel; Pyrantel embonate ; Fenbendazole

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic area:

praziquantel, combinations

Authorization date:

2022-05-27

Summary of Product characteristics

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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DV8WORM 50 mg/ 144 mg/ 200 mg Tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCES:
Praziquantel
50 mg
Pyrantel embonate
144 mg
Fenbendazole
200 mg
_ _
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellow or yellowish grey round scored tablets.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by nematodes and cestodes of the
following species and life stages of
parasite:
Nematodes:
Ascarids:
_Toxocara canis, Toxascaris leonina _
(L5 and adults)
_ _
Hookworms:
_Ancylostoma caninum, Uncinaria stenocephala _
(adults)
Whipworms:
_Trichuris vulpis _
(adults)
Cestodes:
Tapeworms:
_Dipylidium caninum, Taenia hydatigena, Taenia pisiformis_
.,
_Echinococcus granulosus _
(adult and late immature forms).
_ _
The
veterinary
medicinal
product
is
exclusively
indicated
when
use
against
gastrointestinal
nematodes and cestodes is indicated at the same time.
4.3.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4.
SPECIAL WARNING FOR EACH TARGET SPECIES
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Fleas serve as intermediate hosts for one common type of tapeworm –
_Dipylidium caninum_
.
Tapeworm infestation is certain to reoccur unless control of
intermediate hosts such as fleas, mice,
etc. is undertaken.
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated
use of an anthelmintic of that class.
Care should be taken to avoid the following practices because they
increase the risk of development
of resistance and could ultimately result in ineffective therapy.
Strategies that should be avoided because they might lead to an
increased risk of development of
resistance to anthelmintic drugs include:
-
Too frequent and repeated use of anthelmintics from the same
                                
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