SUMEX 5 MG/ML POUR-ON SOLUTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-12-2016
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Active ingredient:
IVERMECTIN
Available from:
Chanelle Animal Health Ltd.
ATC code:
QP54AA01
INN (International Name):
IVERMECTIN
Dosage:
5 Mg/Ml
Pharmaceutical form:
Pour-on Solution
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Ivermectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization date:
2007-01-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sumex 5 mg/ml Pour on Solution for Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE INGREDIENT
Ivermectin
5.0 mg
EXCIPIENTS
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pour-on solution.
A clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 06/12/2016_
_CRN 7025090_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following species of gastrointestinal roundworms, lungworms, warbles, mites and lice:
GASTRO-INTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi _(including inhibited _O ostertagi_)
_Haemonchus placei_
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Cooperia _spp
_Oesophagostomum radiatum_
_Strongyloides papillosus _(adult only)
_Trichuris _spp (adult only)
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
EYE WORMS (ADULT):
_Thelazia _spp
WARBLES (PARASITIC STAGES):
_Hypoderma bovis_
_Hypoderma lineatum_
MITES:
_Chorioptes bovis _(reduction of infestation)
_Sarcoptes scabiei _var _bovis_.
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
BITING LICE:
_Damalinia bovis_
The product given at the recommended dosage of 500 micrograms/kg bodyweight, has persistent activity against _Trichostrongylus_
_axei _and _Cooperia _spp acquired during the 14 days after treatment, only if the whole herd is treated simultaneously. It also has a
persistent activity against _Ostertagia ostertagi _and _Oesophagostomum radiatum _acquired during the first 21 days after treatment
and _Dictyocaulus viviparus _(lungworm) acquired during the fi
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