Promec 18.7 mg/g Oral Paste for Horses

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ivermectin

متاح من:

ECO Animal Health Europe Limited

ATC رمز:

QP54AA01

INN (الاسم الدولي):

Ivermectin

جرعة:

18.7 milligram(s)/gram

الشكل الصيدلاني:

Oral paste

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجال العلاجي:

ivermectin

الوضع إذن:

Authorised

تاريخ الترخيص:

2019-06-21

خصائص المنتج

Health Products Regulatory Authority
23 July 2019
CRN000YR7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Promec 18.7 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Ivermectin 18.7 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 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.
Health Products Regulatory Authority
23 July 2019
CRN000YR7
Page 2 of 5
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 dev