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

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Ivermectin; Praziquantel

Disponible des:

Norbrook Laboratories (Ireland) Limited

Codi ATC:

QP54AA51

Designació comuna internacional (DCI):

Ivermectin; Praziquantel

Dosis:

18.7, 140.3 milligram(s)/gram

formulario farmacéutico:

Oral paste

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

ivermectin, combinations

Estat d'Autorització:

Authorised

Data d'autorització:

2013-09-27

Fitxa tècnica

Health Products Regulatory Authority
15 January 2019
CRN008TFC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noropraz, 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)
Health Products Regulatory Authority
15 January 2019
CRN008TFC
Page 2 of 7
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)
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 development of resistance and could ultimately