Closamectin Solution for Injection for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin; Closantel sodium dihydrate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP54AA51

INN (International Name):

Ivermectin; Closantel sodium dihydrate

Dosage:

5, 125 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin, combinations

Authorization status:

Authorised

Authorization date:

2007-11-09

Summary of Product characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin Solution for Injection for Cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE(S):
Ivermectin
5mg
Closantel (as Closantel Sodium Dihydrate)
125mg
Sodium Formaldehyde Sulphoxylate
5mg
EXCIPIENT(S):
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS_ _
Povidone K12
_ _
Macrogol 200
_ _
Glycerol Formal
_ _
3 CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
3.2 INDICATIONS FOR USE FOR EACH 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)
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_
The veterinary medicinal product may also be used as an aid in the
control of the biting louse
_Damalinia bovis _
and the mange mite
_Chorioptes bovis_
, but complete elimination may not occur.
P