产品特点
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noropraz, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses (IE, UK
, MT
)
Noromectin Praziquantel Duo, 18.7 mg/g + 140.3 mg/g Oral Paste for Horses (AT, BE, BG, CY, CZ,
DK, EE, FI, FR, DE, EL, HU, IT, LV, LT, LU,
MT,
NO, NL, PL, PT, RO, SK, SI, ES, SE)
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 a 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)
CEST
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