Iverpraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Ivermectin; Praziquantel

Disponible depuis:

Norbrook Laboratories (Ireland) Limited

Code ATC:

QP54AA51

DCI (Dénomination commune internationale):

Ivermectin; Praziquantel

Dosage:

18.7, 140.3 milligram(s)/gram

forme pharmaceutique:

Oral paste

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

ivermectin, combinations

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-09-27

Résumé des caractéristiques du produit

Health Products Regulatory Authority
01 April 2019
CRN008Z7Z
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Iverpraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
​
​
​
ACTIVE SUBSTANCE:
Ivermectin
18.7
mg
Praziquantel
140.3
mg
​
​
​
EXCIPIENT(S):
Titanium Dioxide (E171)
20
mg
​
​
​
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral paste.
A white to off white homogenous paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed cestode and nematode or arthropod
infestations, due to adult and immature roundworms,
lungworms, bots and tapeworms in horses:
NEMATODES:
Large strongyle:
_Strongylus vulgaris_ (adult and arterial larvae),
_Strongylus edentatus_ (adult and L4 tissue larval stages)
_Strongylus equinus_ (adult), _Tridontophorus_ spp. (adult)
Small strongyle:
Cyathostomum: _Cylicocyclus_ spp., _Cylicostephanus_ spp.,
_Cylicodontophorus_ spp.,
_Gyalocephalus_ spp. (adult and non-inhibited mucosal larvae)
Parascaris: _Parascaris equorum_ (adult and larvae)
Oxyuris: _Oxyuris equi_ (larvae)
Trichostrongylus: _Trichostrongylus axei_ (adult)
Strongyloides: _Strongyloides westeri_ (adult)
Habronema: _Habronema_ spp. (adult)
Onchocerca: _Onchocerca_ spp. microfilariae i.e. cutaneous
onchocerciasis
Lungworm: _Dictyocaulus arnfieldi_ (adult and larvae)
CESTODES (Tapeworm):
_Anoplocephala perfoliata_ (adult), _Anoplocephala magna _(adult),
_Paranoplocephala mamillana_ (adult)
_ _
DIPTERAN INSECTS:
_Gasterophilus_ spp. (larvae)
Health Products Regulatory Authority
01 April 2019
CRN008Z7Z
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in foals under 2 weeks of age.
Do not use in case of hypersensitivity to the active substances or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk of developmen