Animec 18.7 mg/g Oral Paste for Horses

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Ivermectin

זמין מ:

ECO Animal Health Europe Limited

קוד ATC:

QP54AA01

INN (שם בינלאומי):

Ivermectin

כמות:

18.7 milligram(s)/gram

טופס פרצבטיות:

Oral paste

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

ivermectin

מצב אישור:

Authorised

תאריך אישור:

2006-11-10

מאפייני מוצר

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