Dugmectin 18.7 mg/g Oral Paste for Horses

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ivermectin

Tillgänglig från:

ECO Animal Health Europe Limited

ATC-kod:

QP54AA01

INN (International namn):

Ivermectin

Dos:

18.7 milligram(s)/gram

Läkemedelsform:

Oral paste

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

ivermectin

Bemyndigande status:

Authorised

Tillstånd datum:

2007-01-05

Produktens egenskaper

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