Bimeprine 5 mg/ml pour-on solution for cattle

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Eprinomectin

Mevcut itibaren:

Cross Vetpharm Group Limited

ATC kodu:

QP54AA04

INN (International Adı):

Eprinomectin

Doz:

5 milligram(s)/millilitre

Farmasötik formu:

Pour-on solution

Reçete türü:

LM: Licensed Merchant as defined in relevant national legislation

Terapötik alanı:

eprinomectin

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2018-06-22

Ürün özellikleri

Health Products Regulatory Authority
22 June 2018
CRN000VN3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimeprine 5 mg/ml pour-on solution for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains:
​
ACTIVE SUBSTANCE:
​
​
Eprinomectin
​
5.00 mg
​
EXCIPIENTS:
​
​
Butylhydroxytoluene (E 321)
​
0.10 mg
​
All-rac-alpha-tocopherol (E 307)
​
0.06 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
Pale yellow to yellow clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and dairy cattle).
Health Products Regulatory Authority
22 June 2018
CRN000VN3
Page 2 of 11
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infestations by the following parasites sensitive to
eprinomectin:
Cattle:
- Warbles (parasitic stages):
_Hypoderma bovis_
_Hypoderma lineatum_
- Mange mites:
_Chorioptes bovis_
_Sarcoptes scabiei var. Bovis_
- Sucking lice:
_Linognathus vituli_
_Haematopinus eurysternus_
_Solenopotes capillatus_
- Biting lice:
_Bovicola (Damalinia) bovis_
- Horn flies:
_Haematobia irritans_
The product protects the animals against reinfestations with:
Health Products Regulatory Authority
22 June 2018
CRN000VN3
Page 3 of 11
-_ Nematodirus helvetianus _for 14 days.
- _Trichostrongylus axei _for 21 days.
-_ Dictyocaulus viviparus, Haemonchus placei, Cooperia oncophora,
Cooperia punctata, _
_Cooperia surnabada, Oesophagostomum radiatum _and _Ostertagia
ostertagi _for 28
days_._
The duration of persistent efficacy can be variable for Cooperia spp
and H. placei 14
days after treatment in particular in young and lean animals at the
time of treatment.
4.3 CONTRAINDICATIONS
Avermectins may not be well tolerated in non-target species (including
dogs, cats
and horses). Cases of mortality are reported in dogs, especially
Collies, bobtail and
related breeds and crosses, and also in turtles/tortoises.
Do not use in other animal species.
Do not administer orally or by injection.