Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Moxidectin; Triclabendazole

Sẵn có từ:

Zoetis Belgium S.A.

Mã ATC:

QP54AB52

INN (Tên quốc tế):

Moxidectin; Triclabendazole

Liều dùng:

5/200 milligram(s)/millilitre

Dạng dược phẩm:

Pour-on solution

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Cattle

Khu trị liệu:

moxidectin, combinations

Chỉ dẫn điều trị:

Endectoparasiticides

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2013-12-09

Đặc tính sản phẩm

ANNEX I
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
Each ml contains:
ACTIVE SUBSTANCES:
Moxidectin
5.0 mg
Triclabendazole
200.0 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
_ _
Butylhydroxytoluene (E321)
5.0 mg
γ-Hexalactone
_ _
Cineole
_ _
Caprylocaproyl Macrogolglycerides
A clear, amber liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of mixed trematode (fluke) and nematode infections and
certain arthropod infestations
caused by moxidectin and triclabendazole sensitive strains of:
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_
●
●
ECTOPARASITES
_Linognathus vituli _
●
_Bovicola bovis _
●
_Solenopotes capillatus _
●
The product has a persistent effect in preventing re-infection by
_Ostertagia ostertagi_
and by
_Dictyocaulus viviparus_
for 5 weeks after a single dose.
3.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substances
or to any of the excipient(s).
3.4
SPECIAL WARNINGS
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.
Underdosing, which may be due to underestimation of body weight,
misadm