Wellplus Flavoured tablets for Dogs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Febantel; Pyrantel embonate ; Praziquantel

MAH:

Divasa-Farmavic S.A.

ATC_code:

QP52AA30

INN:

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:

combinations of quinoline derivatives and related substances

therapeutic_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

2013-12-13

SPC

Health Products Regulatory Authority
31 October 2018
CRN000YGP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Wellplus Flavoured tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
​
Praziquantel
50 mg
​
Pyrantel embonate
144 mg
​
Febantel
​150 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Yellowish round tablets with brown dots. _The tablets can be divided
into equal halves _
_or equal quarters. _
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed infestations with the following roundworms
and
tapeworms in dogs and puppies:
​
Ascarids:
​_Toxocara canis_, _Toxascaris leonina _(adult and late immature
forms)
​
Hookworms:
​_Uncinaria stenocephala_, _Ancylostoma caninum _(adults)
​
Tapeworms:
_Echinococcus granulosus_, _Echinococcus multilocularis_, _Dipylidium
_
_caninum_, _Taenia _spp., _Multiceps multiceps_ (adult and immature
forms)
Health Products Regulatory Authority
31 October 2018
CRN000YGP
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in cases of known hypersensitivity to the active substances
or to any of
the excipients.
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 reoccur unless control of
intermediate hosts such
as fleas, mice, etc. is undertaken.
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Parasite resistance to any particular class of anthelmintic may
develop following
frequent, repeated use of an anthelmintic of that class.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion, seek medical advice immediately and
show the
package leaflet