Deltanil 10 mg/ml Pour-on Solution for cattle and sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Deltamethrin

Available from:

Virbac S.A.

ATC code:

QP53AC11

INN (International Name):

Deltamethrin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

deltamethrin

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2014-03-28

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2019
CRN009G0G
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Deltanil 10 mg/ml Pour-on Solution for cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Deltamethrin 10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
Slightly yellowish clear oily solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As a topical application for the treatment and prevention of
infestations by lice and flies on cattle; ticks, lice, keds and
established blowfly strike on sheep and lice and ticks on lambs.
On cattle: For the treatment and prevention of infestations by both
sucking and biting lice, including _Bovicola bovis, _
_Solenopotes capillatus, Linognathus vituli_ and _Haematopinus
eurysternus_. Also as an aid in the treatment and prevention of
infestations by both biting and nuisance flies including _Haematobia
irritans, Stomoxys calcitrans, Musca _species and _Hydrotaea _
_irritans_.
On sheep: For the treatment and prevention of infestations by ticks
_Ixodes ricinus_ and by lice (_Linognathus ovillus, Bovicola ovis_),
keds (_Melophagus ovinus_)
For the treatment of established blowfly strike (usually_ Lucilia
spp_).
On lambs: For the treatment and prevention of infestations by ticks
_Ixodes ricinus_ and by lice _Bovicola ovis_.
4.3 CONTRAINDICATIONS
Do not use on convalescent or sick animals.
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
Do not use in animals with extensive lesions of the skin.
Extra-label use of the product in the non-target species dogs and cats
can lead to toxic neurological signs (ataxia, convulsions,
tremors), digestive signs (hypersalivation, vomiting) and may be
fatal.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
To avoid resistance, the product should only be used if the
susceptibility of the local fly populatio