ZANTEL
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
25-08-2015
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Virkt innihaldsefni:
PRAZIQUANTEL, FENBENDAZOLE
Fáanlegur frá:
Chanelle Pharmaceuticals Manufacturing Limited
ATC númer:
QP52AA51
INN (Alþjóðlegt nafn):
PRAZIQUANTEL, FENBENDAZOLE
Skammtar:
50/500
Lyfjaform:
Tablets
Gerð lyfseðils:
CAM-Companion Animal Medicine
Meðferðarhópur:
Canine
Lækningarsvæði:
Praziquantel, combinations
Ábendingar:
Endoparasiticide
Leyfisstaða:
Authorised
Leyfisdagur:
2003-11-04
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ZANTEL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Per tablet
Praziquantel
50.0 mg
Fenbendazole
500.0 mg
EXCIPIENTS
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A round buff-coloured tablet with a quarter score.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 10/08/2015_
_CRN 7021375_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A broad spectrum anthelmintic for the treatment of mixed infections by nematodes and cestodes in dogs.
Ascarids
_Toxocara canis (immature, adult)_
Toxascaris leonina (immature, adult)
Hookworms
_Uncinaria stenocephala (immature, adult)_
_Ancylostoma caninum (immature, adult)_
Whipworms
_Trichuris vulpis (adult)_
Tapeworms
_Echinococcus granulosus_
_Echinococcus multilocularis_
_Dipylidium caninum_
_Taenia pisiformis_
_Taenia hydatigena_
4.3 CONTRAINDICATIONS
Do not use in puppies under the age of 2 weeks.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Since one of the most common tapeworms of the dog and cat (_Dipylidium caninum_) is transmitted by a flea and has a
very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm and the
risk of re-infection.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an
anthelmintic of that class.
Refer to Section 4.3.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands after the administration to th
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