SUMEX 1% W/V SOLUTION FOR INJECTION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2016
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Active ingredient:
IVERMECTIN
Available from:
Chanelle Animal Health Ltd.
ATC code:
QP54AA01
INN (International Name):
IVERMECTIN
Dosage:
1 %w/v
Pharmaceutical form:
Solution for Injection
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Porcine
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 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
________________________________________________________________________________________________________________________
_Date Printed 23/12/2015_
_CRN 7022492_
_page number: 1_
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
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