Closone 50mg/ml Oral Suspension for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Closantel

Available from:

Norbrook Laboratories Limited

ATC code:

QP52AG09

INN (International Name):

Closantel

Pharmaceutical form:

Oral suspension

Prescription type:

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

Therapeutic group:

Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Expired

Authorization date:

2016-08-04

Summary of Product characteristics

Issued August 2016
AN 00563/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closone 50mg/ml Oral Suspension for Sheep (UK)
Solantel 50mg/ml Oral Suspension for Sheep (BE, ES, FR, IT, PT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Closantel
50.0 mg
(as Closantel Sodium Dihydrate
54.375mg)
EXCIPIENT(S):
Propylene glycol (E1520)
217.6 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Off-white to yellow suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of chronic and subacute fasciolosis (due to _
Fasciola hepatica_).
The product is effective against mature and late immature flukes (from
5 weeks
immature).
For the treatment of _Oestrus ovis_ (Sheep Nasal Bot Fly)_._
For the treatment of inhibited, L4 and adult stages of _Haemonchus
contortus_.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any
of the excipients.
4.4
SPECIAL WARNINGS FOR 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:
Issued August 2016
AN 00563/2015
Page 2 of 6

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,
misadministration of the product, or lack of calibration of the dosing
device (if
any).
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
test(s)
strongly
suggest
resistance
to
a
particular
anthelmintic, an anthelmintic belonging to another pharmacological
class and
having a different mode of action should be used.
Resistance to closantel has been reported in _ Haemonchus_ species
outside the
EU.
The
use
of