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 (Ireland) Limited

ATC code:

QP53AC11

INN (International Name):

Deltamethrin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

deltamethrin

Authorization status:

Authorised

Authorization date:

2014-09-05

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2020
CRN009S74
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Spotinor 10 mg/ml Spot-on Solution for cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each ml contains
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ACTIVE SUBSTANCE:
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Deltamethrin
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10 mg
For the 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_.
4.3 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.
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 is
assured.
Cases of resistance