Endogard Plus Flavour Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate ; Praziquantel

Available from:

Krka, d.d., Novo mesto

ATC code:

QP52AC55

INN (International Name):

Febantel; Pyrantel embonate ; Praziquantel

Dosage:

150, 144, 50 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

febantel, combinations

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2011-06-03

Summary of Product characteristics

Health Products Regulatory Authority
19 May 2020
CRN009LZG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endogard Plus Flavour Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel 50 mg
Pyrantel embonate 144 mg
Febantel 150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Yellow coloured, round, biconvex tablets with visible darker spots,
cross-scored on one side.
The tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (small and medium 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 and puppies:
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 exceed the stated dosage when treating pregnant bitches.
Do not use in animals with a known hypersensitivity to the active
substance or to any of excipients.
Not for use in dogs younger than 2 weeks of age and/or weighing less
than 2 kg
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
19 May 2020
CRN009LZG
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Any part-used tablets should be discarded.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In the interests of good hygiene, persons administering the tablet
directly to a dog or by adding it to the dog's food should
wash their hands afterwar