Closamectin Solution for Injection for Cattle and Sheep

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, Sheep

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

2006-07-28

Summary of Product characteristics

Revised: February 2013
AN: 00171/2012
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin Solution for Injection for Cattle and Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Ivermectin
5 mg
Closantel (as closantel sodium dihydrate)
125 mg
Excipients:
Sodium formaldehyde sulphoxylate
5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution free from visible particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and Sheep.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
CATTLE:
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: February 2013
AN: 00171/2012
Page 2 of 9
Liver Fluke (trematodes)
_Fasciola gigantica, Fasciola hepatica_
Treatment of fluke at 12 weeks (mature) >99% efficacy.
Treatment of fluke from 7 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_
Closamectin In