Drontal Tasty Bone Wormer 150/144/50 mg tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

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SPC SPC (SPC)
24-08-2019

active_ingredient:

Febantel; Pyrantel embonate ; Praziquantel

MAH:

Bayer Limited

ATC_code:

QP52AC55

INN:

Febantel; Pyrantel embonate ; Praziquantel

dosage:

150,144,50 mg/tablet

pharmaceutical_form:

Tablet

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

febantel, combinations

therapeutic_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

2014-10-24

SPC

                                Health Products Regulatory Authority
23 August 2019
CRN008VNL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Tasty Bone Wormer 150/144/50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
150 mg febantel
50 mg pyrantel equivalent to 144 mg pyrantel embonate
50 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 and cestodes of the
following species:
Roundworms:
Ascarids (adult and late immature forms): _Toxocara canis, Toxascaris
leonina_
Hookworms (adults): _Uncinaria stenocephala, Ancylostoma caninum_
Whipworms (adults): _Trichuris vulpis_
Tapeworms (adult and late immature forms): _Echinococcus granulosus_
_Echinococcus multilocularis_
_Dipylidium caninum_
_Taenia spp._
_Mesocestoides spp._
To help control infections caused by the protozoa _Giardia spp_, in
puppies and adult dogs.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use during the 1st and 2nd third 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
23 August 2019
CRN008VNL
Page 2 of 5
In case your dog develops diarrhoea, please ask your veterinarian for
evaluation and diagnosis to determine the cause before
beginning treatment with this product. Diarrhoea can be caused by the
protozoa _Giardia spp_. but this disease should be
confirmed so as to exclude other potential causes.
4.5 SPECIAL PRECAUTIONS FOR USE

                                
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