Endex 8.75 % w/v Oral Suspension for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triclabendazole, Levamisole hydrochloride

Available from:

Elanco Europe Ltd

ATC code:

QP52AC30

INN (International Name):

Triclabendazole, Levamisole hydrochloride

Dosage:

8.75 percent weight/volume

Pharmaceutical form:

Oral suspension

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Sheep

Therapeutic area:

combinations of benzimidazoles and related substances

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2016-10-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endex 8.75 % w/v Oral Suspension for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral suspension.
A white to off-white aqueous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the simultaneous treatment and control of mature and immature
infections, including inhibited stages of stomach
worms (_Haemonchus, Ostertagia, Trichostrongylus axei_), gut worms
(_Trichostrongylus, Cooperia, Nematodirus,_
_Busonstomum, Gaigeria, Chabertia, Oesophagostomum_) and lung worms
(_Dictyocaulus)_ as well as all forms of liver fluke
infection (early immature, immature and adult stages of_ Fasciola
hepatica and Fasciola gigantica_ susceptible to
triclabendazole).
For the treatment and control of nematodes resistant to benzimidazoles
and probenzimidazoles, macrolide anthelmintics
(e.g. ivermectin), salicylanides and tetrahydropyrimidines.
4.3 CONTRAINDICATIONS
Do not administer to animals with known hypersensitivity to the active
ingredients.
Do not administer to goats.
Active Substances
Triclabendazole
5.0
% w/v
Levamisole hydrochloride
3.75
% w/v
Excipients
Methyl parahydroxybenzoate (E218)
0.095 % w/v
Propyl parahydroxybenzoate (E216)
0.035 % w/v
Benzoic acid (E210)
0.1
% w/v
Sodium metabisulphite (E223)
0.25
% w/v
For a full list of excipients, see section 6.1
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