Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Closantel, Ivermectin

Available from:

Norbrook Laboratories Limited

ATC code:

QP54AA51

INN (International Name):

Closantel, Ivermectin

Pharmaceutical form:

Pour-on solution

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Cattle

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

2009-08-04

Summary of Product characteristics

Revised: April 2022
AN: 02842/2021 & 00070/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5mg/ml + 200 mg/ml Pour-On Solution for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT(S)
Ivermectin
5 mg/ml
Closantel (as closantel sodium)
200 mg/ml
EXCIPIENTS
Brilliant Blue FCF (E133)
0.1 mg/ml
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Pour-On solution.
A clear blue/green solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed trematode (fluke) and nematode or arthropod
infestations due to roundworms, lungworms, eyeworms, warbles, mites
and lice
of cattle.
Gastrointestinal roundworms (adults and fourth stage larvae)
_Ostertagia _
_ostertagi _
(including
inhibited
_O. _
_ostertagi_),
_Haemonchus _
_placei_,
_Trichostrongylus _
_axei_,
_Trichostrongylus _
_colubriformis_,
_Cooperia_
spp_, _
_Oesophagostomum radiatum, Nematodirus helvetianus_ (adult), _
Strongyloides _
_papillosus _(adult).
Lungworms (adult and fourth stage larvae)
_Dictyocaulus viviparus_
Trematodes (adult and late immatures)
_Fasciola gigantica_
_Fasciola hepatica_
Treatment of fluke at 12 weeks (mature) >95% efficacy.
Treatment of fluke at 7 weeks (late immature) >95% efficacy.
Revised: April 2022
AN: 02842/2021 & 00070/2022
Page 2 of 8
Eyeworms (adult)
_Thelazia_ spp
Cattle grubs (parasitic stages)
_Hypoderma bovis, Hypoderma lineatum_
Lice
_Linognathus vituli, Haematopinus eurysternus, Damalinia bovis_
Mange Mites
_Chorioptes bovis, Sarcoptes scabiei _var _bovis_
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substances
or to
any of the excipients.
Do not apply to areas of skin which have mange, scabs or other lesions
or to
areas contaminated with mud or manure.
Avermectins
may
not
be
well
tolerated
in
non-target
species
(cases
of
intolerance with fatal outcome are reported in dogs – especially
Collies, Old
English Sheep