Topimec Super Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin; Clorsulon

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA51

INN (International Name):

Ivermectin; Clorsulon

Dosage:

10, 100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

ivermectin, combinations

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2011-10-14

Summary of Product characteristics

Health Products Regulatory Authority
02 July 2018
CRN000YH7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Topimec Super Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE(S):
Ivermectin
10
mg
Clorsulon
100
mg
EXCIPIENTS:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
A clear colourless to pale yellow coloured non-aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In beef and non-lactating dairy cattle:
For the treatment of mixed infestations of the following parasite
species:
GASTROINTESTINAL ROUNDWORMS (ADULT AND FOURTH-STAGE LARVAE):
_Ostertagia _spp_._ (including inhibited _O. ostertagi_)
_Haemonchus placei_
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Cooperia_ spp.
_Bunostomum phlebotomum_
_Oesophagostomum radiatum_
_Strongyloides papillosus_ (adult only)
_Nematodirus helvetianus _(adult only)
_Nematodirus spathiger _(adult only)
Health Products Regulatory Authority
02 July 2018
CRN000YH7
Page 2 of 7
_Toxocara vitulorum_
_Trichuris _spp. (adult only)
LUNGWORM (ADULT AND FOURTH-STAGE LARVAE):
_Dictyocaulus viviparus_
LIVER FLUKE (ADULT):
_Fasciola hepatica_
EYE WORMS (ADULT):
_Thelazia_ spp.
WARBLES (PARASITIC STAGES):
_Hypoderma bovis_
_H. lineatum_
MANGE MITES:
_Psoroptes bovis_
_Sarcoptes scabiei var. bovis_
SUCKING LICE:
_Linognathus vituli _
_Haematopinus eursternus_
_Solenopotes capillatus_
The veterinary medicinal product may also be used as an aid in the
control of biting
lice (_Damalinia bovis_) and the mange mite _Chorioptes bovis_, but
complete elimination
may not occur.
PERSISTENT ACTIVITY
When cattle have to graze on pasture contaminated with infective
larvae of cattle
nematodes, treatment with the product at the recommended dose rate can
control
re-infection with _Haemonchus placei _and _Cooperia_ spp., acquired up
to 14 days after
treatment, _Ostertagia ostertagi _and _Oes