Dugmectin 18.7 mg/g Oral Paste for Horses

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ivermectin

Boleh didapati daripada:

ECO Animal Health Europe Limited

Kod ATC:

QP54AA01

INN (Nama Antarabangsa):

Ivermectin

Dos:

18.7 milligram(s)/gram

Borang farmaseutikal:

Oral paste

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kawasan terapeutik:

ivermectin

Status kebenaran:

Authorised

Tarikh kebenaran:

2007-01-05

Ciri produk

Health Products Regulatory Authority
21 March 2019
CRN008Y4L
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dugmectin 18.7 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ivermectin
18.7 mg/g
EXCIPIENT(S):
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Paste.
A white homogeneous paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of nematode or arthropod infections due to:
Large strongyles:
_Strongylus vulgaris_ (adults and L
4
stage larvae [arterial])
_Strongylus edentatus_ (adults and L
4
stage larvae [tissue])
_Strongylus equinus_ (adults)
Small strongyles (including benzimidazole resistant strains):
_Cyathostomum _spp_. _(adults and luminal L
4
stage larvae)
_Cylicocyclus _spp. (adults and luminal L
4
stage larvae)
_Cylicodontophorus _spp. (adults and luminal L
4
stage larvae)
_Cylicostephanus _spp. (adults and luminal L
4
stage larvae)
_Gyalocephalus_ spp. (adults and luminal L
4
stage larvae)
Ascarids:
_Parascaris equorum_ (luminal L5 larvae and adults)
Pinworms:
_Oxyuris equi_ (L
4
stage larvae and adults)
Neck threadworms:
_Onchocerca _spp_._ (microfilariae)
Stomach bots:
_Gasterophilus _spp_._ (oral and gastric stages)
Health Products Regulatory Authority
21 March 2019
CRN008Y4L
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in horses with known hypersensitivity to the active
substance or to any of the excipients.
Do not use in dogs or cats as severe adverse reactions may occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Some horses with heavy infections of _Onchocerca_ spp. microfilariae
have experienced oedema and pruritus following treatment,
such reactions are assumed to be the result of death of large numbers
of microfilariae. These signs resolve within a few days
but symptomatic treatment may be advisable.
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and