Spotinor 10 mg/ml Spot-on Solution for cattle and sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Deltamethrin

Available from:

Norbrook Laboratories Limited

ATC code:

QP53AC11

INN (International Name):

Deltamethrin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Spot-on solution

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

deltamethrin

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

2014-09-05

Summary of Product characteristics

Health Products Regulatory Authority
14 March 2018
CRN000X32
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Spotinor 10 mg/ml Spot-on Solution for cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains
​
​
ACTIVE SUBSTANCE:
​
​
Deltamethrin
​10 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-On Solution.
A clear pale gold oily liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_ in beef and dairy cattle. Also as an aid in
the treatment
and prevention of infestations of 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 established
blowfly strike (usually _Lucilia spp_).
On lambs: For the treatment and prevention of infestations by ticks
_Ixodes ricinus _and
by lice _Bovicola ovis_.
Health Products Regulatory Authority
14 March 2018
CRN000X32
Page 2 of 8
4.3 CONTRAINDICATIONS
Do not use on convalescent or sick animals.
Do not use in cases of known hypersensitivity to the active substance
or 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
To avoid resistance, the product should only be used if the
susceptibility of the local
fly population to the active substance i