Solantel 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:

Closantel sodium dihydrate

Sẵn có từ:

Norbrook Laboratories (Ireland) Limited

Mã ATC:

QP52AG09

INN (Tên quốc tế):

Closantel sodium dihydrate

Liều dùng:

200 milligram(s)/millilitre

Dạng dược phẩm:

Pour-on solution

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

closantel

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2021-06-11

Đặc tính sản phẩm

Health Products Regulatory Authority
14 June 2021
CRN009NJY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Solantel 200 mg/ml Pour-On Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml of solution contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Closantel
​200
mg​
​
(as Closantel Sodium Dihydrate 217.5 mg)
​
​
​
EXCIPIENTS:
​
​
​
Brilliant Blue FCF (E133)
​0.1
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Pour-On solution.
A clear blue/green solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of late immature (> 7 weeks) and adult _Fasciola
hepatica _(fluke) infestations of cattle.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not apply to areas of skin which have mange, scabs or other lesions
or to areas contaminated with mud or manure.
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.
Underdosing which may be due to underestimation of bodyweight,
misadministration of the product, or lack of calibration of
the dosing device.
The effect of rain on the pour-on formulation at the time of and after
application has not been investigated. For maximum
effect animals should be kept indoors or undercover following
treatment, when there is rain or an imminent risk of rain.
Suspected clinical cases of resistance to anthelmintics should be
further investigated using appropriate tests (e.g., Faecal Egg
Count Reduction Test). Where the results of the tests strongly suggest
resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a d