ENDOGARD PLUS XL TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-11-2016
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Active ingredient:
FEBANTEL, PYRANTEL EMBONATE, PRAZIQUANTEL
Available from:
Krka, d.d., Novo mesto
ATC code:
QP52AC55
INN (International Name):
FEBANTEL, PYRANTEL EMBONATE, PRAZIQUANTEL
Dosage:
525/504/17
Pharmaceutical form:
Tablets
Prescription type:
CAM-Companion Animal Medicine
Therapeutic group:
Canine
Therapeutic area:
Febantel, combinations
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2011-06-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endogard Plus XL Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
175 mg
Pyrantel embonate
504 mg
Febantel
525 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Oval, biconvex tablets with bevelled edges and scored on both sides. Slightly greenish-yellow.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (large and extra large size)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed infestations with the following roundworms and tapeworms in adult dogs:
Nematodes:
Ascarids: _Toxocara canis_, _Toxascaris leonina _(late immature forms and mature forms)
Hookworms: _Uncinaria stenocephala_, _Ancylostoma caninum _(adults)
Cestodes:
Tapeworms: _Taenia _spp., _Dipylidium caninum_
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in animals with a known hypersensitivity to the active substance or to any of excipients.
Do not exceed the stated dosage when treating pregnant bitches.
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 re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 20/10/2016_
_CRN 7024627_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This product is not recommended for use in dogs under 17.5 kg body weight.
Any part-used tablets should be discarded.
Spe
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