Sumex 1% w/v, solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Chanelle Animal Health Ltd.

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

1.0 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

ivermectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2002-06-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sumex 1% w/v, solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin
1.0 % w/v (10 mg/ml)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to slightly yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Beef and non lactating cattle)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the effective treatment of the following
harmful parasites of cattle:
GASTRO-INTESTINAL ROUNDWORMS:
_Ostertagia_ spp (including inhibited_ O. ostertagi_
_(adult and L4_)),
_Haemonchus placei (adult and L4_),
_Trichostrongylus spp (adult and L4_),
_Cooperia_ spp_ (adult and L4_),
_Nematodirus spp (adult_),
LUNGWORMS (adult and fourth stage larvae):
_Dictyocaulus viviparus_
WARBLES (parasitic stages):
_Hypoderma spp_
MANGE MITES:
_Psoroptes bovis_
_Sarcoptes scabiei_ var._ bovis_.
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
PERSISTENT ACTIVITY
Treatment at the recommended dose rate controls re-infection with_
Haemonchus placei_ and_ Cooperia spp._ acquired up
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to 14 days after treatment,
_Ostertagia ostertagi_
acquired up to 21 days after treatment
and_ Dictyocaulus vivi