Anthelmin Plus XL Tablets for dogs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
12-04-2018
DSU DSU (DSU)
27-11-2023

Aktiivinen ainesosa:

Febantel; Pyrantel embonate ; Praziquantel

Saatavilla:

Krka, d.d., Novo mesto

ATC-koodi:

QP52AC55

INN (Kansainvälinen yleisnimi):

Febantel; Pyrantel embonate ; Praziquantel

Annos:

525, 504, 175 mg/tablet

Lääkemuoto:

Tablet

Prescription tyyppi:

CAM: Companion Animal Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

febantel, combinations

Käyttöaiheet:

Endoparasiticide

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-05-01

Valmisteyhteenveto

                                Health Products Regulatory Authority
11 April 2018
CRN000XZH
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Anthelmin 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
11 April 2018
CRN000XZH
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 dose 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.
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
This product is not recommended for use in dogs under 17.5 kg
bodyweight.
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 hygien
                                
                                Lue koko asiakirja