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 Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

1.0 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2002-06-28

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 1 of 6
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_.
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 6
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
PERSISTENT ACTIVITY
Treatment at the recommended dose rate controls re-infection with
_Haemonchusplacei_ and _Cooperia spp. _acquired up to 14 days after
treatment,
_Ostertagia ostertagi_ acquired up to 21 days after treatment and
_Dictyocaulus _
_viviparus_ acquired up to 28 days after treatment.
To obtain maximum benefit from the persistent activity of the product
for grazing
animals it is recommended that calves which are set-stocked in their
first grazing
season should be treated 3, 8 and 13 weeks after the day of turn-out.
This can
protect the animals from parasitic gastroenteritis and lungworm
disease throughout
the grazing season, provided they are set-stocked, all the calves are
included in the
programme and that no untreated cattle are added to the pasture.
Treated calves should always be monitored according t