Nullamec 5 mg/ml pour-on solution for cattle

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Eprinomectin

Prieinama:

Cross Vetpharm Group Limited

ATC kodas:

QP54AA04

INN (Tarptautinis Pavadinimas):

Eprinomectin

Dozė:

5 milligram(s)/millilitre

Vaisto forma:

Pour-on solution

Recepto tipas:

LM: Licensed Merchant as defined in relevant national legislation

Farmakoterapinė grupė:

Cattle

Gydymo sritis:

eprinomectin

Terapinės indikacijos:

Endectoparasiticides

Autorizacija statusas:

Authorised

Leidimo data:

2018-06-14

Prekės savybės

Health Products Regulatory Authority
15 June 2018
CRN000VMP
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nullamec 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).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infestations by the following parasites sensitive to
eprinomectin:
Cattle:
Health Products Regulatory Authority
15 June 2018
CRN000VMP
Page 2 of 10
- 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:
-_ 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_. _
Health Products Regulatory Authority
15 June 2018
CRN000VMP
Page 3 of 10
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 injecti