ENDEX 19.5 % W/V ORAL SUSPENSION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-04-2016
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Active ingredient:
TRICLABENDAZOLE, LEVAMISOLE HYDROCHLORIDE
Available from:
Novartis Animal Health UK Ltd
ATC code:
QP52AC30
INN (International Name):
TRICLABENDAZOLE, LEVAMISOLE HYDROCHLORIDE
Dosage:
19.5 %w/v
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Combinations of benzimidazoles and related substances
Therapeutic indications:
Endoparasiticide
Authorization status:
Transfer Pending
Authorization date:
2010-05-07
Summary of Product characteristics
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
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Endex 19.5% is not suitable for sheep.
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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/03/2016_
_CRN 7023313_
_page number: 1_
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 M
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