CYDECTIN TRICLAMOX 5 MG/ML + 200 MG/ML POUR-ON SOLUTION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOXIDECTIN TRICLABENDAZOLE

Available from:

Pfizer Healthcare Ireland

ATC code:

QP54AB52

Pharmaceutical form:

Pour-on Solution

Therapeutic group:

Endectoparasiticides

Therapeutic area:

Bovine

Authorization date:

2012-04-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
A clear, amber liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
Each ml contains:
Active substances
Moxidectin
5.0
mg
Triclabendazole
200.0 mg
Excipients
Butylhydroxytoluene (E321) 5.0
mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/04/2012_
_CRN 7008291_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
Treatment of mixed trematode (fluke) and nematode infections caused by moxidectin and triclabendazole
sensitive strains of:
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance(s) or to any of the excipient(s).
Parasite
Adult stage
Inhibited stages
NEMATODES
L4
GASTRO-INTESTINAL NEMATODES:
_Haemonchus placei_
_Ostertagia ostertagi_
_Trichostrongylus axei_
_Nematodirus helvetianus_
_Cooperia oncophora_
_Cooperia punctata_
_Oesophagostomum radiatum_
_Bunostomum phlebotomum_
RESPIRATORY TRACT NEMATODE:
_Dictyocaulus viviparus_
TREMATODES
LIVER FLUKE:
6 - 8 weeks
immatures
_Fasciola hepatica_
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/04/2012_
_CRN 7008291_
_page number: 2_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they increase the risk of development of resistance and
could ultimately result in ineffective therapy:
•
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
•
Un