Endex 19.5 % w/v Oral Suspension for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triclabendazole; Levamisole hydrochloride

Available from:

Elanco GmbH

ATC code:

QP52AC30

INN (International Name):

Triclabendazole; Levamisole hydrochloride

Dosage:

19.5 percent weight/volume

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

combinations of benzimidazoles and related substances

Authorization status:

Authorised

Authorization date:

2016-10-21

Summary of Product characteristics

Health Products Regulatory Authority
21 August 2018
CRN008DKW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endex 19.5 % w/v Oral Suspension for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Active substance
​
​
​
Triclabendazole
12.0​
% w/v​
​
Levamisole hydrochloride
7.5​
% w/v​
​
Excipients
​
​
​
Methyl parahydroxybenzoate E218
0.08​
% w/v​
​
Propyl parahydroxybenzoate E216
0.03​
% 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.
​
​
3 PHARMACEUTICAL FORM
Oral suspension. A white to off-white aqueous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the simultaneous treatment and control of mature and developing
immature
infections of stomach worms _(Haemonchus, Ostertagia, Trichostrongylus
axei_), gut
worms (_Trichostrongylus, Cooperia, Nematodirus, Bunostomum,
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_) in
cattle.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredients.
Do not use for the control of inhibited Type II Ostertagia
infestations.
Health Products Regulatory Authority
21 August 2018
CRN008DKW
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Endex 19.5% is not suitable for sheep.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product is effective on the mature and developing immature stages
of
Ostertagia, but is not indicated for the control of inhibited larvae
(i.e. Type II
ostertagiasis).
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product is