Cydectin TriclaMox 1mg/ml + 50 mg/ml Oral Solution for sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Moxidectin; Triclabendazole

Available from:

Zoetis Belgium S.A.

ATC code:

QP54AB52

INN (International Name):

Moxidectin; Triclabendazole

Dosage:

1/50 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Sheep

Therapeutic area:

moxidectin, combinations

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin TriclaMox 1 mg/ml + 50 mg/ml oral solution for sheep
Cydectin TriclaMox 1 mg/ml + 50 mg/ml orale Lösung für Schafe
(Austria, Germany)
Cydectine TriclaMox 1 mg/ml + 50 mg/ml solution orale pour ovins
(Belgium, France, Luxembourg)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml Πόσιμο διάλυμα
για πρόβατα (Greece)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml
mixtúra, lausn handa sauðfé (Iceland)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml soluzione orale per pecore
(Italy)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml oral solution for sheep
(Ireland, UK)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml orale oplossing voor schapen
(The Netherlands)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml solução oral para ovinos
(Portugal)
Cydectin TriclaMox 1 mg/ml + 50 mg/ml solución oral para ovino
(Spain)
TriclaMox vet. 1 mg/ml + 50 mg/ml, oral lösning till får (Sweden)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Moxidectin
1.0 mg
Triclabendazole
50.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzyl alcohol (E1519)
40.0 mg
Butylhydroxytoluene (E321)
1.0 mg
Polysorbate 80
_ _
Sorbitan oleate
Propylene glycol, dicaprylocaprate
A clear yellow to brown liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of mixed nematode and fluke infections, caused by
moxidectin and triclabendazole
sensitive strains of:
PARASITE
ADULT STAGE
L4
INHIBITED STAGES
NEMATODES
GASTRO-INTESTINAL NEMATODES:
_Haemonchus contortus_
•
•
•
_Teladorsagia circumcincta_
•
•
•
_Ostertagia trifurcata_
•
•
_Trichostrongylus axei_
•
•
•
_Trichostrongylus colubriformis_
•
•
_Trichostrongylus vitrinus_
•
•
_Nematodirus battus_
•
•
_Nematodirus spathiger_
•
•
_Nematodirus filicolis_