Deltadot 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:

Bimeda Animal Health Limited

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 area:

deltamethrin

Authorization status:

Authorised

Authorization date:

2016-09-23

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Deltadot 10 mg/ml Pour-on Solution for Cattle and Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Deltamethrin
10.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Triglycerides, medium chain
A clear pale gold oily liquid
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and sheep.
3.2
INDICATIONS FOR USE
FOR EACH TARGET SPECIES
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_
) and 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_
.
3.3
CONTRAINDICATIONS
Do not use on convalescent or sick animals.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
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.
Do not use in animals with extensive lesions of the skin.
3.4
SPECIAL WARNINGS
The product will reduce the number of flies resting directly on the
animal but it is not expected to
eliminate all flies on a farm. Resistance to deltamethrin has been
recognised and therefore the strategic
use of the product should be based on local and regional
epidemiological information about
susceptibility of parasites, and used in association with other pest
management methods.
Care should be taken to a