Solantel 200mg/ml Pour-On Solution for Cattle

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Closantel Sodium Dihydrate

Dostępny od:

Norbrook Laboratories Limited

Kod ATC:

QP52AG09

INN (International Nazwa):

Closantel Sodium Dihydrate

Forma farmaceutyczna:

Pour-on solution

Typ recepty:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Grupa terapeutyczna:

Cattle

Dziedzina terapeutyczna:

Anthelmintic flukicide

Status autoryzacji:

Authorized

Data autoryzacji:

2021-06-16

Charakterystyka produktu

Issued: June 2021
AN: 02022/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Solantel 200mg/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.
Issued: June 2021
AN: 02022/2019
Page 2 of 7
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 different mode of action should be used.
4.5
SPECIAL PRECAU