Norofas 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:

2011-06-23

Summary of Product characteristics

Revised: September 2021
AN: 01045/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norofas Pour-On Solution for Cattle (UK)
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).
Treatment of fluke at 7 weeks (late immature).
Revised: September 2021
AN: 01045/2021
Page 2 of 9
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.
The product has been formulated for topical application specifically
for
cattle. It should not be administered to other species as severe
adverse
reactions including fatalities in dogs, may occur.
4.4
SPECIAL WARNINGS
Care s