Sumex 1% w/v solution for injection for pigs

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 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 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sumex 1% w/v solution for injection for pigs
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
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the effective treatment of the following
harmful parasites
of pigs:
GASTROINTESTINAL WORMS (adult and fourth stage larvae):
_Ascaris suum,_
_Hyostrongylus rubidus_,
_Oesophagostomum spp_,
_Strongyloides ransomi_ (adult and somatic larval stage)
LUNGWORMS:
_Metastrongylus spp_. (adult)
LICE:
Haematopinus suis
MANGE MITES:
_Sarcoptes scabiei_ var. _suis_
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not administer by the intravenous or intramuscular route.
Do not use in cases of known hypersensitivity to the active
ingredient.
Do not use in cats and dogs as severe adverse reactions may occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Parasite resistance to any particular class of anthelmintic may
develop following
frequent, repeated use of an anthelmintic of that class. It is
important that the correct
dose is given in order to minimise the risk of resistance.
Assess bodyweight as accurately as possible before calculating the
dose.
The product has been formulated specifically for use in pigs only. Do
not use in cats
and dogs. Avermectins may not be well tolerated in all non-target
species (cases of
intolerance with fatal outcome are reported in dogs - especially
Collies, Old English
Sheepdogs and related breeds or crosses, and also in
turtles/tortoises).
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDIC