Endogard Plus XL 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:

525, 504, 175 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
03 April 2018
CRN000XZF
Page 1 of 6
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_
Health Products Regulatory Authority
03 April 2018
CRN000XZF
Page 2 of 6
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.
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.
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 afterwards.
In case of accidental ingestion, seek medic