Endogard Plus XL Tablets for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
04-04-2018
Opinber matsskýrsla Opinber matsskýrsla (PAR)
31-10-2018
DSU DSU (DSU)
27-11-2023

Virkt innihaldsefni:

Febantel; Pyrantel embonate ; Praziquantel

Fáanlegur frá:

Krka, d.d., Novo mesto

ATC númer:

QP52AC55

INN (Alþjóðlegt nafn):

Febantel; Pyrantel embonate ; Praziquantel

Skammtar:

525, 504, 175 mg/tablet

Lyfjaform:

Tablet

Gerð lyfseðils:

CAM: Companion Animal Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

febantel, combinations

Ábendingar:

Endoparasiticide

Leyfisstaða:

Authorised

Leyfisdagur:

2011-06-03

Vara einkenni

                                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
                                
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