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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
02-04-2019
Shusha DSU (DSU)
19-07-2023

Viambatanisho vya kazi:

Ivermectin; Praziquantel

Inapatikana kutoka:

Norbrook Laboratories (Ireland) Limited

ATC kanuni:

QP54AA51

INN (Jina la Kimataifa):

Ivermectin; Praziquantel

Kipimo:

18.7, 140.3 milligram(s)/gram

Dawa fomu:

Oral paste

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Eneo la matibabu:

ivermectin, combinations

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-09-27

Tabia za bidhaa

                                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
                                
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