Sumex 5 mg/ml Pour on Solution for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2007-01-19

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2018
CRN008QMW
Page 1 of 7
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.
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_
Health Products Regulatory Authority
12 November 2018
CRN008QMW
Page 2 of 7
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 first 28 days after treatment. It also
has a persistent
activity on horn flies (Haematobia irritans) for 28 days after
treatment, partial efficacy
may last for up to 35 days post application. Occasionally variable
activity may be
observed against Ha