Animec 18.7 mg/g Oral Paste for Horses

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ivermectin

Fáanlegur frá:

ECO Animal Health Europe Limited

ATC númer:

QP54AA01

INN (Alþjóðlegt nafn):

Ivermectin

Skammtar:

18.7 milligram(s)/gram

Lyfjaform:

Oral paste

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

ivermectin

Leyfisstaða:

Authorised

Leyfisdagur:

2006-11-10

Vara einkenni

Health Products Regulatory Authority
26 March 2019
CRN008YYF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Animec 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 infection 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 L
5
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)
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs or cats as severe adverse reactions may occur.
Health Products Regulatory Authority
26 March 2019
CRN008YYF
Page 2 of 5
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 could
ultimately resu