VOXICAL PLUS TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-05-2015
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Active ingredient:
PRAZIQUANTEL, PYRANTEL EMBONATE, FEBANTEL
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QP52AA51
INN (International Name):
PRAZIQUANTEL, PYRANTEL EMBONATE, FEBANTEL
Dosage:
50/144/150
Pharmaceutical form:
Tablets
Prescription type:
CAM-Companion Animal Medicine
Therapeutic group:
Canine
Therapeutic area:
Praziquantel, combinations
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2010-07-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Voxical Plus Tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Tablet.
A pale yellow tablet with a cross breakline on one side.
The tablets can be divided into equal halves or equal quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs: Treatment of mixed infections by nematodes and cestodes of the following species
NEMATODES:
ASCARIDS: _Toxocara canis_, _Toxascaris leonina _(adult and late immature forms).
HOOKWORMS: _Uncinaria stenocephala_, _Ancylostoma caninum _(adults).
WHIPWORMS: _Trichuris vulpis _(adults).
CESTODES:
TAPEWORMS: _Echinococcus _species, _(E. granulosus, E. multilocularis), Taenia _species, _(T. hydatigena, T. pisiformis, T._
_taeniformis), Dipylidium caninum _(adult and immature forms).
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Do not use the product during the first 4 weeks of pregnancy.
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
50 mg
Pyrantel
50 mg (equivalent to 144 mg pyrantel embonate)
Febantel
150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 12/05/2015_
_CRN 7020590_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 th
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