Bayer Dog Tasty Bone XL 525/504/175 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate ; Praziquantel

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AA51

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 area:

praziquantel, combinations

Authorization status:

Authorised

Authorization date:

2017-09-08

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2020
CRN009RGL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bayer Dog Tasty Bone XL 525/504/175 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
525 mg febantel
175 mg pyrantel equivalent to 504 mg pyrantel embonate
175 mg praziquantel
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A light-brown to brown, meat flavoured, bone shaped tablet scored on
both sides that can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by nematodes andcestodes of the
following species:
​
Roundworms:
​
​
Ascarids (adult and late immatureforms):
​_Toxocara canis, Toxascaris leonina_
​
Hookworms(adults):
​_Uncinaria stenocephala, Ancylostoma caninum_
​
Whipworms(adults):
​_Trichuris vulpis_
​
​
​
Tapeworms (adult and immatureforms):
​_Echinococcus granulosus_
​
​_Echinococcus multilocularis_
​
_​Dipylidium caninum_
​
​_Taenia spp._
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to
any of the excipients.
Do not use during the 1st and 2nd trimester of pregnancy (see section
4.7).
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
22 June 2020
CRN009RGL
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Parasite resistance to any particular class of anthelmintic may
develop following frequent, repeated use of an anthelmintic of
that class.
To minimise the risk of reinfestation and new infestation, excreta
should be collected and properly disposed of for 24 hours
following treatment.
Special precautions to be tak