Norofas Solution for Injection

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:

Solution for injection

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Endectocide

Authorization status:

Expired

Authorization date:

2007-12-21

Summary of Product characteristics

Revised: June 2013
AN: 00253/2013
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norofas Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
Ivermectin
0.5% w/v
Closantel (as closantel sodium dihydrate)
12.5% w/v
EXCIPIENTS
Sodium Formaldehyde Sulphoxylate
0.5% w/v
For a full list of excipients see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear amber 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 gastrointestinal roundworms, lungworms, eyeworms,
warbles,
mites and lice of cattle.
Gastrointestinal roundworms
_Ostertagia ostertagi _ (including inhibited larval stages), _
Ostertagia lyrata _ (adult),
_Haemonchus _
_placei_
(adult
and
immature),
_Trichostrongylus _
_axei _
(adult
and
immature),
_Trichostrongylus _
_colubriformis _
(adult
and
immature),
_Cooperia _
_oncophora _
(adult
and
immature),
_Cooperia _
_punctata_
(adult
and
immature),
_Cooperia pectinata _(adult and immature)_,_ _Oesophagostomum radiatum
_(adult and
immature),
_Nematodirus _
_helvetianus _
(adult),
_Nematodirus _
_spathiger_
(adult),
_Strongyloides papillosus_ (adult), _Bunostomum phlebotomum _(adult
and immature),
_Toxocara vitulorum_ (adult), _Trichuris_ spp.
Lungworms
_Dictyocaulus viviparus_ (adult and 4
th
stage larvae)
Revised: June 2013
AN: 00253/2013
Page 2 of 7
Liver Fluke (trematodes)
_Fasciola gigantica, Fasciola hepatica_
Treatment of fluke at 12 weeks (mature) >99% efficacy.
Treatment of fluke at 9 weeks (late immature) >90% efficacy
Eyeworms (adult)
_Thelazia_ spp
Cattle grubs (parasitic stages)
_Hypoderma bovis, Hypoderma lineatum_
Lice
_Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus_
Mange Mites
_Psoroptes ovis (_syn_ P communis _var_ bovis), Sarcoptes scabiei _var
_bovis_
Norofas Injection may also be used as an aid in the control of the
biting lo